Trial Outcomes & Findings for Phase Ib Study of BKM120 With Cisplatin and XRT in High Risk Locally Advanced Squamous Cell Cancer of Head and Neck (NCT NCT02113878)
NCT ID: NCT02113878
Last Updated: 2024-11-05
Results Overview
The trial uses 3+3 design to determine maximum tolerated dose (MTD).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
While on treatment, up to 66 days
Results posted on
2024-11-05
Participant Flow
September 29, 2014-December 5, 2017
Participant milestones
| Measure |
Dose Level 1
* 40 mg BKM120 will be administered orally daily for 45 days. Starting dose 40 mg.
* Cisplatin: Starting Dose 30 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43).
* Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks.
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.
Cisplatin: Cisplatin is a chemotherapy drug
Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
|
Dose Level 2
* 40 mg BKM120 will be administered orally daily for 45 days.
* Cisplatin: Starting Dose 35 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43).
* Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks.
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.
Cisplatin: Cisplatin is a chemotherapy drug
Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
6
|
|
Overall Study
COMPLETED
|
14
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Dose Level 1
* 40 mg BKM120 will be administered orally daily for 45 days. Starting dose 40 mg.
* Cisplatin: Starting Dose 30 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43).
* Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks.
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.
Cisplatin: Cisplatin is a chemotherapy drug
Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
|
Dose Level 2
* 40 mg BKM120 will be administered orally daily for 45 days.
* Cisplatin: Starting Dose 35 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43).
* Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks.
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.
Cisplatin: Cisplatin is a chemotherapy drug
Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
patient non-compliance
|
1
|
0
|
Baseline Characteristics
Phase Ib Study of BKM120 With Cisplatin and XRT in High Risk Locally Advanced Squamous Cell Cancer of Head and Neck
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=17 Participants
* 40 mg BKM120 will be administered orally daily for 45 days. Starting dose 40 mg.
* Cisplatin: Starting Dose 30 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43).
* Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks.
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.
Cisplatin: Cisplatin is a chemotherapy drug
Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
|
Dose Level 2
n=6 Participants
* 40 mg BKM120 will be administered orally daily for 45 days.
* Cisplatin: Starting Dose 35 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43).
* Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks.
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.
Cisplatin: Cisplatin is a chemotherapy drug
Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 7.1 • n=99 Participants
|
57.2 years
STANDARD_DEVIATION 4.17 • n=107 Participants
|
62.0 years
STANDARD_DEVIATION 7.02 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Stage
Clinical Cancer Stage 3
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Stage
Clinical Cancer Stage 4
|
17 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Primary Disease Site
Hypopharynx
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Primary Disease Site
Oral Cavity
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Primary Disease Site
Oropharynx
|
11 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Primary Disease Site
Larynx
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Primary Disease Site
Oth
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Smoking History
Yes
|
17 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Smoking History
No
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Number of Pack Years
Greater than 10
|
17 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Number of Pack Years
Less than or equal to 10
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Current Smoker
Yes
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Current Smoker
No
|
15 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: While on treatment, up to 66 daysPopulation: \*One additional patient enrolled in Dose Level 1 per physician discretion
The trial uses 3+3 design to determine maximum tolerated dose (MTD).
Outcome measures
| Measure |
Dose Level 1 and Dose Level 2
n=23 Participants
* 40 mg BKM120 will be administered orally daily for 45 days.
* Cisplatin: Starting Dose 30 mg/m2 (Dose Level 1) or 35 mg/m2 (Dose Level 2), given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43).
* Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks.
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.
Cisplatin: Cisplatin is a chemotherapy drug
Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
|
Dose Level 2
* 40 mg BKM120 will be administered orally daily for 45 days.
* Cisplatin: Starting Dose 35 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43).
* Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks.
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.
Cisplatin: Cisplatin is a chemotherapy drug
Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
|
|---|---|---|
|
Maximum Tolerated Dose of Cisplatin
|
30 mg/m2
|
—
|
PRIMARY outcome
Timeframe: While on treatment, up to 66 daysPopulation: \*One additional patient enrolled in Dose Level 1 per physician discretion
The trial uses 3+3 design to determine maximum tolerated dose (MTD).
Outcome measures
| Measure |
Dose Level 1 and Dose Level 2
n=23 Participants
* 40 mg BKM120 will be administered orally daily for 45 days.
* Cisplatin: Starting Dose 30 mg/m2 (Dose Level 1) or 35 mg/m2 (Dose Level 2), given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43).
* Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks.
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.
Cisplatin: Cisplatin is a chemotherapy drug
Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
|
Dose Level 2
* 40 mg BKM120 will be administered orally daily for 45 days.
* Cisplatin: Starting Dose 35 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43).
* Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks.
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.
Cisplatin: Cisplatin is a chemotherapy drug
Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
|
|---|---|---|
|
Maximum Tolerated Dose of BKM120
|
40 mg
|
—
|
SECONDARY outcome
Timeframe: Measured at end of treatment, up to 66 daysThe best overall response for each patient is given per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1) criteria: Complete Response (CR) - Disappearance of all target and non-target lesions and lymph node short axis is \<10 mm and no new lesions Partial Response (PR) * Disappearance of target lesions and \>=1 persisting non-target lesion or tumor marker levels above normal limits and no new lesions or * \>=30% decrease in sum of target lesion diameter and no new lesions Stable Disease (SD) \- Less than 5 mm increase in target lesion diameter unless it results in a \>=20% increase in diameter and \>=1 persisting non-target lesion or tumor marker levels above normal limits and no new lesions Progressive Disease (PD) * \>20% increase in target lesion diameter, must be an absolute increase of 5mm or * Substantial worsening in non-target lesion or * New lesion present
Outcome measures
| Measure |
Dose Level 1 and Dose Level 2
n=17 Participants
* 40 mg BKM120 will be administered orally daily for 45 days.
* Cisplatin: Starting Dose 30 mg/m2 (Dose Level 1) or 35 mg/m2 (Dose Level 2), given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43).
* Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks.
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.
Cisplatin: Cisplatin is a chemotherapy drug
Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
|
Dose Level 2
n=6 Participants
* 40 mg BKM120 will be administered orally daily for 45 days.
* Cisplatin: Starting Dose 35 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43).
* Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks.
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.
Cisplatin: Cisplatin is a chemotherapy drug
Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
|
|---|---|---|
|
Best Overall Response
Complete Response
|
6 Participants
|
2 Participants
|
|
Best Overall Response
Partial Response
|
6 Participants
|
2 Participants
|
|
Best Overall Response
Stable Disease
|
0 Participants
|
1 Participants
|
|
Best Overall Response
Progressive Disease
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 24 months (Progression is defined using RECIST v1.0 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions)The median amount of time from baseline to progression and/or death. Patients known to be alive at last contact are censored at last contact. All patients alive at 24 months from baseline are censored at 24 months.
Outcome measures
| Measure |
Dose Level 1 and Dose Level 2
n=17 Participants
* 40 mg BKM120 will be administered orally daily for 45 days.
* Cisplatin: Starting Dose 30 mg/m2 (Dose Level 1) or 35 mg/m2 (Dose Level 2), given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43).
* Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks.
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.
Cisplatin: Cisplatin is a chemotherapy drug
Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
|
Dose Level 2
n=6 Participants
* 40 mg BKM120 will be administered orally daily for 45 days.
* Cisplatin: Starting Dose 35 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43).
* Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks.
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.
Cisplatin: Cisplatin is a chemotherapy drug
Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
|
|---|---|---|
|
Median Time to Progression
|
14.5 months
Interval 13.3 to 22.8
|
NA months
Only 1 event occurred and 5 patients were censored. Therefor a median time to progression was not reached
|
SECONDARY outcome
Timeframe: Up to 24 monthsThe probability of survival at 24 months using Kaplan-Meier estimates. Patients alive at 2 years are censored at 2 years.
Outcome measures
| Measure |
Dose Level 1 and Dose Level 2
n=17 Participants
* 40 mg BKM120 will be administered orally daily for 45 days.
* Cisplatin: Starting Dose 30 mg/m2 (Dose Level 1) or 35 mg/m2 (Dose Level 2), given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43).
* Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks.
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.
Cisplatin: Cisplatin is a chemotherapy drug
Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
|
Dose Level 2
n=6 Participants
* 40 mg BKM120 will be administered orally daily for 45 days.
* Cisplatin: Starting Dose 35 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43).
* Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks.
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.
Cisplatin: Cisplatin is a chemotherapy drug
Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
|
|---|---|---|
|
24 Month Overall Survival
|
0.929 probability of survival
Interval 0.591 to 0.99
|
0.240 probability of survival
Interval 0.239 to 0.246
|
SECONDARY outcome
Timeframe: From baseline to cycle 9, up to 66 days.The median change in score on the Generalized Anxiety Disorder - 7 (GAD-7) questionnaire from baseline to cycle 9.GAD-7 has 7 questions and each question has score from 0 to 3. Sum score of all questions will be used as the final score. The final score ranges from 0 to 21. Higher score represents worse anxiety.
Outcome measures
| Measure |
Dose Level 1 and Dose Level 2
n=17 Participants
* 40 mg BKM120 will be administered orally daily for 45 days.
* Cisplatin: Starting Dose 30 mg/m2 (Dose Level 1) or 35 mg/m2 (Dose Level 2), given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43).
* Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks.
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.
Cisplatin: Cisplatin is a chemotherapy drug
Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
|
Dose Level 2
n=6 Participants
* 40 mg BKM120 will be administered orally daily for 45 days.
* Cisplatin: Starting Dose 35 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43).
* Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks.
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.
Cisplatin: Cisplatin is a chemotherapy drug
Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
|
|---|---|---|
|
Median Anxiety Score Change
|
-0.5 points
Interval -5.0 to 6.0
|
0 points
Interval -3.0 to 1.0
|
SECONDARY outcome
Timeframe: From baseline to cycle 9, up to 66 days.The median change in score on the Patient Health Questionnaire - 9 (PHQ-8) from baseline to cycle 9. PHQ-9 has 9 questions and each question has score from 0 to 3. Sum score of all questions will be used as the final score. The final score ranges from 0 to 27. Higher score represents worse depression.
Outcome measures
| Measure |
Dose Level 1 and Dose Level 2
n=17 Participants
* 40 mg BKM120 will be administered orally daily for 45 days.
* Cisplatin: Starting Dose 30 mg/m2 (Dose Level 1) or 35 mg/m2 (Dose Level 2), given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43).
* Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks.
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.
Cisplatin: Cisplatin is a chemotherapy drug
Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
|
Dose Level 2
n=6 Participants
* 40 mg BKM120 will be administered orally daily for 45 days.
* Cisplatin: Starting Dose 35 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43).
* Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks.
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.
Cisplatin: Cisplatin is a chemotherapy drug
Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
|
|---|---|---|
|
Median Depression Score Change
|
1 points
Interval -4.0 to 9.0
|
0 points
Interval -8.0 to 0.0
|
SECONDARY outcome
Timeframe: Biopsies drawn up to 10 days from registration. Response measured at from baseline to cycle 9, up to 66 days.Population: Biomarker data was not collected for all patients. Data reported for all patients who were biopsied.
Phosphoinositide 3-kinase (PI3K) biomarker status, either positive or negative, analyzed using established methods from tumor biopsies. P13K status is reported by response, either responder (CR or PR) or non-responder (SD or PR).
Outcome measures
| Measure |
Dose Level 1 and Dose Level 2
n=15 Participants
* 40 mg BKM120 will be administered orally daily for 45 days.
* Cisplatin: Starting Dose 30 mg/m2 (Dose Level 1) or 35 mg/m2 (Dose Level 2), given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43).
* Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks.
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.
Cisplatin: Cisplatin is a chemotherapy drug
Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
|
Dose Level 2
n=4 Participants
* 40 mg BKM120 will be administered orally daily for 45 days.
* Cisplatin: Starting Dose 35 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43).
* Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks.
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.
Cisplatin: Cisplatin is a chemotherapy drug
Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
|
|---|---|---|
|
P13K Status by Response
P13K Positive - Responder
|
2 Participants
|
1 Participants
|
|
P13K Status by Response
P13K Positive - Non-Responder
|
1 Participants
|
1 Participants
|
|
P13K Status by Response
P13K Negative - Responder
|
9 Participants
|
1 Participants
|
|
P13K Status by Response
P13K Negative - Non-Responder
|
3 Participants
|
1 Participants
|
Adverse Events
Dose Level 1
Serious events: 17 serious events
Other events: 0 other events
Deaths: 1 deaths
Dose Level 2
Serious events: 6 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Dose Level 1
n=17 participants at risk
* 40 mg BKM120 will be administered orally daily for 45 days. Starting dose 40 mg.
* Cisplatin: Starting Dose 30 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43).
* Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks.
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.
Cisplatin: Cisplatin is a chemotherapy drug
Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
|
Dose Level 2
n=6 participants at risk
* 40 mg BKM120 will be administered orally daily for 45 days.
* Cisplatin: Starting Dose 35 mg/m2, given IV, weekly on days: (1, 8, 15, 22, 29, 36 and 43).
* Radiotherapy: All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks.
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.
Cisplatin: Cisplatin is a chemotherapy drug
Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Investigations
Alanine aminotransferase increased
|
11.8%
2/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Blood and lymphatic system disorders
Anemia
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
16.7%
1/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Metabolism and nutrition disorders
Anorexia
|
70.6%
12/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
100.0%
6/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Psychiatric disorders
Anxiety
|
23.5%
4/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
33.3%
2/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Cardiac disorders
Atrial fibrillation
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
16.7%
1/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Investigations
Blood bilirubin increased
|
11.8%
2/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
33.3%
2/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Eye disorders
Blurred vision
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Injury, poisoning and procedural complications
Bruising
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Investigations
Cholesterol high
|
17.6%
3/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Psychiatric disorders
Confusion
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Gastrointestinal disorders
Constipation
|
70.6%
12/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
66.7%
4/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.6%
3/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
33.3%
2/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Metabolism and nutrition disorders
Dehydration
|
23.5%
4/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
33.3%
2/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Psychiatric disorders
Depression
|
29.4%
5/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
16.7%
1/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
58.8%
10/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
100.0%
6/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Infections and infestations
Device related infection
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Gastrointestinal disorders
Diarrhea
|
35.3%
6/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
50.0%
3/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Nervous system disorders
Dizziness
|
17.6%
3/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
16.7%
1/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Eye disorders
Dry eye
|
11.8%
2/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Gastrointestinal disorders
Dry mouth
|
52.9%
9/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
100.0%
6/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
17.6%
3/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Nervous system disorders
Dysgeusia
|
64.7%
11/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
100.0%
6/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
16.7%
1/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Gastrointestinal disorders
Dysphagia
|
58.8%
10/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Nervous system disorders
Dysphasia
|
17.6%
3/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
50.0%
3/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
16.7%
1/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Ear and labyrinth disorders
Ear pain
|
17.6%
3/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
General disorders
Edema face
|
0.00%
0/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
16.7%
1/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
General disorders
Edema limbs
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
16.7%
1/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
General disorders
Edema trunk
|
11.8%
2/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Gastrointestinal disorders
Esophageal pain
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
General disorders
Fatigue
|
52.9%
9/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
83.3%
5/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
General disorders
Fever
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
General disorders
Gait disturbance
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
35.3%
6/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
33.3%
2/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
17.6%
3/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
33.3%
2/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
11.8%
2/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
16.7%
1/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Psychiatric disorders
Hallucinations
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Nervous system disorders
Headache
|
29.4%
5/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Ear and labyrinth disorders
Hearing impaired
|
17.6%
3/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
16.7%
1/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
52.9%
9/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
66.7%
4/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Vascular disorders
Hypertension
|
29.4%
5/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
17.6%
3/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
23.5%
4/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
16.7%
1/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
17.6%
3/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
33.3%
2/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
17.6%
3/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
16.7%
1/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Endocrine disorders
Hypothyroidism
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
29.4%
5/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
66.7%
4/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Psychiatric disorders
Insomnia
|
23.5%
4/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
33.3%
2/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Investigations
Investigations - Other, specify
|
11.8%
2/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
16.7%
1/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Infections and infestations
Lip infection
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
16.7%
1/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Investigations
Lipase increased
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Infections and infestations
Lung infection
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Vascular disorders
Lymphedema
|
47.1%
8/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
33.3%
2/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Nervous system disorders
Memory impairment
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
23.5%
4/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Infections and infestations
Mucosal infection
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Gastrointestinal disorders
Mucositis oral
|
88.2%
15/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
100.0%
6/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
33.3%
2/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Gastrointestinal disorders
Nausea
|
70.6%
12/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
83.3%
5/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
General disorders
Neck edema
|
0.00%
0/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
16.7%
1/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.8%
2/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Investigations
Neutrophil count decreased
|
17.6%
3/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
16.7%
1/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
General disorders
Non-cardiac chest pain
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Gastrointestinal disorders
Oral pain
|
29.4%
5/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
66.7%
4/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
General disorders
Pain
|
17.6%
3/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
16.7%
1/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
16.7%
1/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Cardiac disorders
Palpitations
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
33.3%
2/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Nervous system disorders
Paresthesia
|
17.6%
3/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
33.3%
2/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Investigations
Platelet count decreased
|
41.2%
7/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
50.0%
3/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
16.7%
1/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
16.7%
1/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
11.8%
2/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.9%
1/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Infections and infestations
Rash pustular
|
11.8%
2/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
16.7%
1/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
11.8%
2/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
16.7%
1/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
11.8%
2/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Investigations
Serum amylase increased
|
11.8%
2/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
16.7%
1/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Cardiac disorders
Sinus bradycardia
|
11.8%
2/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
16.7%
1/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Infections and infestations
Sinusitis
|
11.8%
2/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
11.8%
2/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
16.7%
1/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Infections and infestations
Skin infection
|
11.8%
2/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
16.7%
1/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
11.8%
2/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
11.8%
2/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Ear and labyrinth disorders
Tinnitus
|
11.8%
2/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
33.3%
2/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Gastrointestinal disorders
Tooth discoloration
|
11.8%
2/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
16.7%
1/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal fistula
|
11.8%
2/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Nervous system disorders
Tremor
|
11.8%
2/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Renal and urinary disorders
Urinary frequency
|
11.8%
2/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
0.00%
0/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
11.8%
2/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
33.3%
2/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
2/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
33.3%
2/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Investigations
Weight loss
|
11.8%
2/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
100.0%
6/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
|
Investigations
White blood cell decreased
|
11.8%
2/17 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
16.7%
1/6 • Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place