Trial Outcomes & Findings for First in Human Study of M1069 in Advanced Solid Tumors (NCT NCT05198349)
NCT ID: NCT05198349
Last Updated: 2026-04-22
Results Overview
A DLT was defined as any AE, per National Cancer Institute - Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0), assessed by the Investigator or Sponsor at any dose, unrelated to underlying disease, prior/concomitant medication, or condition, occurring during the DLT observation period. DLTs included Grade more than equal to (≥) 3 thrombocytopenia with bleeding, excluding isolated Grade 4 lymphopenia without symptoms or Grade 4 neutropenia/thrombocytopenia less than (\<) 7 days without signs. Other DLTs were Hy's Law hepatotoxicity without clear cause, vision changes (≥5-line Best Corrected Visual Acuity (BCVA) loss, BCVA \<20/160, MD \>9 decibel (dB), macular thickness \>25 percentage (%)), severe eye disorders limiting self-care, ≥5-day drug interruption to prevent DLT.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Cycle 1 (first 21 days after first study drug administration)
Results posted on
2026-04-22
Participant Flow
Participant milestones
| Measure |
M1069 150 mg BID
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 150 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 300 mg BID
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 300 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 450 mg BID
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 450 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 600 mg BID
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 600 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
3
|
|
Overall Study
COMPLETED
|
1
|
3
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
M1069 150 mg BID
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 150 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 300 mg BID
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 300 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 450 mg BID
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 450 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 600 mg BID
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 600 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Overall Study
Study Closing
|
1
|
0
|
0
|
0
|
|
Overall Study
Started New Cancer Therapy
|
0
|
0
|
1
|
0
|
Baseline Characteristics
First in Human Study of M1069 in Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
M1069 300 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 300 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 450 mg BID
n=6 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 450 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 600 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 600 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
Total
n=15 Participants
Total of all reporting groups
|
M1069 150 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 150 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
|---|---|---|---|---|---|
|
Age, Continuous
|
52 Years
STANDARD_DEVIATION 19 • n=56 Participants
|
61 Years
STANDARD_DEVIATION 9.6 • n=116 Participants
|
62 Years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
59 Years
STANDARD_DEVIATION 12.2 • n=3 Participants
|
60 Years
STANDARD_DEVIATION 13.1 • n=60 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=56 Participants
|
2 Participants
n=116 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=3 Participants
|
1 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=56 Participants
|
4 Participants
n=116 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=3 Participants
|
2 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=56 Participants
|
5 Participants
n=116 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=3 Participants
|
3 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=56 Participants
|
1 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=56 Participants
|
1 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=56 Participants
|
5 Participants
n=116 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=3 Participants
|
2 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (first 21 days after first study drug administration)Population: DLT set included all participants who received more than or equal to (\>=) 1 M1069 dose and with at least 1 DLT during the DLT period, and/or received at least 80% of the planned cumulative dose during the DLT period, and/or did not receive 80% of the planned total dose, but at least 80% dosing of a different dose cohort and finished the DLT period.
A DLT was defined as any AE, per National Cancer Institute - Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0), assessed by the Investigator or Sponsor at any dose, unrelated to underlying disease, prior/concomitant medication, or condition, occurring during the DLT observation period. DLTs included Grade more than equal to (≥) 3 thrombocytopenia with bleeding, excluding isolated Grade 4 lymphopenia without symptoms or Grade 4 neutropenia/thrombocytopenia less than (\<) 7 days without signs. Other DLTs were Hy's Law hepatotoxicity without clear cause, vision changes (≥5-line Best Corrected Visual Acuity (BCVA) loss, BCVA \<20/160, MD \>9 decibel (dB), macular thickness \>25 percentage (%)), severe eye disorders limiting self-care, ≥5-day drug interruption to prevent DLT.
Outcome measures
| Measure |
M1069 300 mg BID
n=2 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 300 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 450 mg BID
n=5 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 450 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 600 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 600 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 150 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 150 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
|---|---|---|---|---|
|
Number of Participants With Dose-Limiting Toxicities (DLTs)
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 16 monthsPopulation: The Safety analysis set (SAF) included all participants who were administered any dose of any study intervention.
An AE can be any unfavorable and unintended sign, symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. For surgical or diagnostic procedures, the condition/illness leading to such a procedure is considered as the AE rather than the procedure itself. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. An AE was considered as 'treatment emergent' if it occurred after the first drug administration of each period or if it was present prior to drug administration but exacerbated after the drug administration. TEAEs included both serious TEAEs and non-serious TEAEs. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization, results in persistent disability. Treatment Related TEAEs are also reported.
Outcome measures
| Measure |
M1069 300 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 300 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 450 mg BID
n=6 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 450 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 600 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 600 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 150 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 150 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment Related TEAEs and Serious TEAEs
Participants with TEAEs
|
3 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment Related TEAEs and Serious TEAEs
Participants with Serious TEAEs
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment Related TEAEs and Serious TEAEs
Participants with Treatment related TEAEs
|
3 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 8 and 15 of Cycle 1 and Day 1 of Cycle 4 (each cycle is of 21 days)Population: Pharmacokinetic (PK) analysis set included all participants who received at least one dose of study intervention and provided at least one measurable post-dose concentration that is unaffected by any protocol deviations or events that affect its validity.
The AUC from time zero (= dosing time) to the last sampling time (tlast) at which the concentration is at or above the lower limit of quantification. Calculated using the mixed log-linear trapezoidal rule (linear up, log down).
Outcome measures
| Measure |
M1069 300 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 300 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 450 mg BID
n=6 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 450 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 600 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 600 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 150 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 150 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Time of Last Measurable Concentration (AUC0-tlast) of M1069
|
13300 hour* nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 7.6
|
16600 hour* nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 51.1
|
22100 hour* nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 54.1
|
8360 hour* nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 28.7
|
SECONDARY outcome
Timeframe: Day 8 and 15 of Cycle 1 and Day 1 of Cycle 4 (each cycle is of 21 days)Population: The Pharmacokinetic analysis set included all participants who received at least one dose of study intervention and provided at least one measurable post-dose concentration that is unaffected by any protocol deviations or events that affect its validity.
AUC \[0-24\]/D is the Area under plasma concentration time curve from time zero to 24 divided by dose (AUC \[0-24\]/D) of M1069. Calculated using the mixed log-linear trapezoidal rule (linear up, log down).
Outcome measures
| Measure |
M1069 300 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 300 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 450 mg BID
n=6 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 450 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 600 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 600 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 150 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 150 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
|---|---|---|---|---|
|
Area Under Plasma Concentration Time Curve From Time Zero to 24, Divided by Dose (AUC [0-24]/D) of M1069
|
44.5 h*ng/mL/mg
Geometric Coefficient of Variation 7.6
|
37.0 h*ng/mL/mg
Geometric Coefficient of Variation 51.1
|
36.8 h*ng/mL/mg
Geometric Coefficient of Variation 54.1
|
55.8 h*ng/mL/mg
Geometric Coefficient of Variation 28.7
|
SECONDARY outcome
Timeframe: Day 8 and 15 of Cycle 1 and Day 1 of Cycle 4 (each cycle is of 21 days)Population: The Pharmacokinetic analysis set included all participants who received at least one dose of study intervention and provided at least one measurable post-dose concentration that is unaffected by any protocol deviations or events that affect its validity.
Cmax is the maximum observed plasma concentration and was obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
M1069 300 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 300 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 450 mg BID
n=6 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 450 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 600 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 600 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 150 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 150 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of M1069
|
4060 nanogram per mililiter (ng/mL)
Geometric Coefficient of Variation 6.6
|
3840 nanogram per mililiter (ng/mL)
Geometric Coefficient of Variation 68.6
|
4850 nanogram per mililiter (ng/mL)
Geometric Coefficient of Variation 45.7
|
2340 nanogram per mililiter (ng/mL)
Geometric Coefficient of Variation 19.0
|
SECONDARY outcome
Timeframe: Day 8 and 15 of Cycle 1 and Day 1 of Cycle 4 (each cycle is of 21 days)Population: The Pharmacokinetic analysis set included all participants who received at least one dose of study intervention and provided at least one measurable post-dose concentration that is unaffected by any protocol deviations or events that affect its validity.
Cmax/D is the maximum observed plasma concentration by dose. Cmax was obtained directly from the concentration versus time curve, divided by Dose of M1069.
Outcome measures
| Measure |
M1069 300 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 300 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 450 mg BID
n=6 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 450 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 600 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 600 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 150 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 150 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
|---|---|---|---|---|
|
Maximum Observed Plasma (Peak) Drug Concentration, by Dose (Cmax/D)
|
13.5 ng/mL/mg
Geometric Coefficient of Variation 6.6
|
8.53 ng/mL/mg
Geometric Coefficient of Variation 68.6
|
8.08 ng/mL/mg
Geometric Coefficient of Variation 45.7
|
15.6 ng/mL/mg
Geometric Coefficient of Variation 19.0
|
SECONDARY outcome
Timeframe: Day 8 and 15 of Cycle 1 and Day 1 of Cycle 4 (each cycle is of 21 days)Population: The Pharmacokinetic analysis set included all participants who received at least one dose of study intervention and provided at least one measurable post-dose concentration that is unaffected by any protocol deviations or events that affect its validity.
The time to reach the maximum observed plasma concentration (Tmax) was obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
M1069 300 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 300 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 450 mg BID
n=6 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 450 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 600 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 600 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 150 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 150 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
|---|---|---|---|---|
|
Time to Reach Peak or Maximum Observed Concentration or Response Following Drug Administration (Tmax)
|
1.93 hours
Interval 1.53 to 2.0
|
1.49 hours
Interval 1.0 to 2.25
|
2.17 hours
Interval 2.03 to 3.92
|
1.53 hours
Interval 1.5 to 1.97
|
SECONDARY outcome
Timeframe: Time from first observation of response (CR or PR) up to planned assessment at 17.3 monthsPopulation: The Safety analysis included all participants who were administered any dose of any study intervention.
OR is defined as a best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all target lesions. Number of participants with BOR of CR or PR was reported.
Outcome measures
| Measure |
M1069 300 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 300 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 450 mg BID
n=6 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 450 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 600 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 600 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 150 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 150 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
|---|---|---|---|---|
|
Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), as Assessed by Investigator
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), as Assessed by Investigator
Partial Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Time from first observation of response (CR or PR) up to planned assessment at 17.3 monthsPopulation: None of the participants showed objective response, hence Duration of Response was not evaluable.
DoR is the time from when the complete response (CR) or partial response (PR) (whichever is first) criteria are first met until disease progression (PD) or death due to any cause within the period of 2 scheduled tumor assessments after the last tumor assessment, whichever occurs first. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from first administration of study intervention to the date of the first documentation of progression disease (PD) or death due to any cause within, whichever occurs first, assessed up to maximum of 17.3 monthsPopulation: The Safety analysis included all participants who were administered any dose of any study intervention.
PFS is defined as the time (in months) from first administration of study intervention to the date of the first documentation of progression disease (PD) or death due to any cause within the period of 2 scheduled tumor assessments after the last tumor assessment, whichever occurs first. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was to be estimated using Kaplan-Meier (KM) plots.
Outcome measures
| Measure |
M1069 300 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 300 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 450 mg BID
n=6 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 450 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 600 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 600 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 150 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 150 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
|---|---|---|---|---|
|
Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), as Assessed by Investigator
|
1.2 months
Interval 1.2 to 2.6
|
1.3 months
Interval 1.0 to 3.9
|
1.4 months
Interval 1.0 to 12.6
|
1.3 months
Interval 1.3 to 12.6
|
SECONDARY outcome
Timeframe: Cycle (C)1Day (D)1: 1h, 2h, 4h, 6h, 8h post-dose; C1D8: 15min predose, 1h, 2h, 4h, 6h, 8h post-dose; C1D15: predose; C2D1: predose, 2h post-dose; C4D1, C6D1, C10D1, C12D1, C14D1, C18D1(each cycle is of 21 days)Population: The Safety analysis included all participants who were administered any dose of any study intervention.
A 12-lead ECG was recorded with the participant in a supine position after a rest of at least 10 minutes using an ECG machine. Change from baseline in QTc interval was reported. In the Timeframe the "C" refers to Cycle, "D" refers to Day and "h" refers to the hours.
Outcome measures
| Measure |
M1069 300 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 300 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 450 mg BID
n=6 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 450 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 600 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 600 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 150 mg BID
n=3 Participants
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 150 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
|---|---|---|---|---|
|
Change From Baseline in Corrected QT (QTc) Interval
C1D1 1h post-dose
|
-3.67 milliseconds
Interval -17.0 to 7.0
|
10.33 milliseconds
Interval -15.0 to 28.0
|
0.33 milliseconds
Interval -4.0 to 8.0
|
-6.33 milliseconds
Interval -38.0 to 21.0
|
|
Change From Baseline in Corrected QT (QTc) Interval
C1D1 2h post-dose
|
-6.33 milliseconds
Interval -21.0 to 6.0
|
7.67 milliseconds
Interval -3.0 to 24.0
|
3.67 milliseconds
Interval -2.0 to 8.0
|
-10.00 milliseconds
Interval -29.0 to 16.0
|
|
Change From Baseline in Corrected QT (QTc) Interval
C1D1 4h post-dose
|
-11.67 milliseconds
Interval -33.0 to 8.0
|
5.17 milliseconds
Interval -10.0 to 22.0
|
9.67 milliseconds
Interval -3.0 to 34.0
|
-13.33 milliseconds
Interval -43.0 to 18.0
|
|
Change From Baseline in Corrected QT (QTc) Interval
C1D1 6h post-dose
|
3.50 milliseconds
Interval -9.0 to 16.0
|
4.00 milliseconds
Interval -12.0 to 24.0
|
-4.3 milliseconds
Interval -13.0 to 2.0
|
-18.33 milliseconds
Interval -35.0 to 8.0
|
|
Change From Baseline in Corrected QT (QTc) Interval
C1D1 8h post-dose
|
11.00 milliseconds
Interval 4.0 to 18.0
|
3.83 milliseconds
Interval -5.0 to 14.0
|
-5.67 milliseconds
Interval -18.0 to 10.0
|
-27.50 milliseconds
Interval -35.0 to -20.0
|
|
Change From Baseline in Corrected QT (QTc) Interval
C1D8 15min Predose
|
-4.33 milliseconds
Interval -10.0 to -1.0
|
2.67 milliseconds
Interval -17.0 to 22.0
|
21.50 milliseconds
Interval 3.0 to 40.0
|
-10.00 milliseconds
Interval -33.0 to 14.0
|
|
Change From Baseline in Corrected QT (QTc) Interval
C1D8 1h Post dose
|
-0.33 milliseconds
Interval -6.0 to 5.0
|
9.17 milliseconds
Interval -9.0 to 31.0
|
11.33 milliseconds
Interval -7.0 to 41.0
|
-1.33 milliseconds
Interval -32.0 to 16.0
|
|
Change From Baseline in Corrected QT (QTc) Interval
C1D8 2h post-dose
|
2.33 milliseconds
Interval -4.0 to 12.0
|
28.33 milliseconds
Interval -11.0 to 80.0
|
14.00 milliseconds
Interval -7.0 to 55.0
|
-0.67 milliseconds
Interval -28.0 to 15.0
|
|
Change From Baseline in Corrected QT (QTc) Interval
C1D8 4h post-dose
|
-6.67 milliseconds
Interval -17.0 to 0.0
|
23.17 milliseconds
Interval 0.0 to 59.0
|
11.00 milliseconds
Interval -15.0 to 51.0
|
-33.00 milliseconds
Interval -77.0 to 8.0
|
|
Change From Baseline in Corrected QT (QTc) Interval
C1D8 6h post-dose
|
-5.33 milliseconds
Interval -11.0 to -1.0
|
10.50 milliseconds
Interval -5.0 to 22.0
|
10.00 milliseconds
Interval -1.0 to 29.0
|
-19.00 milliseconds
Interval -43.0 to 4.0
|
|
Change From Baseline in Corrected QT (QTc) Interval
C1D8 8h Post dose
|
-4.50 milliseconds
Interval -6.0 to -3.0
|
5.00 milliseconds
Interval -8.0 to 21.0
|
18.00 milliseconds
Interval -5.0 to 34.0
|
-2.00 milliseconds
Interval -41.0 to 18.0
|
|
Change From Baseline in Corrected QT (QTc) Interval
C1D15 Predose
|
-11.50 milliseconds
Interval -14.0 to -9.0
|
-2.25 milliseconds
Interval -11.0 to 8.0
|
0.50 milliseconds
Interval -7.0 to 8.0
|
-0.33 milliseconds
Interval -20.0 to 18.0
|
|
Change From Baseline in Corrected QT (QTc) Interval
C2D1 Predose
|
-0.50 milliseconds
Interval -2.0 to 1.0
|
18.40 milliseconds
Interval 0.0 to 39.0
|
13.00 milliseconds
Interval 1.0 to 25.0
|
-9.00 milliseconds
Interval -17.0 to -2.0
|
|
Change From Baseline in Corrected QT (QTc) Interval
C2D1 2h post-dose
|
7.00 milliseconds
Interval 5.0 to 9.0
|
7.40 milliseconds
Interval -8.0 to 17.0
|
9.50 milliseconds
Interval -4.0 to 23.0
|
-9.33 milliseconds
Interval -45.0 to 15.0
|
|
Change From Baseline in Corrected QT (QTc) Interval
C4D1 Predose
|
-11.00 milliseconds
Interval -11.0 to -11.0
|
-7.00 milliseconds
Interval -17.0 to 3.0
|
-7.00 milliseconds
Interval -7.0 to -7.0
|
28.00 milliseconds
Interval 28.0 to 28.0
|
|
Change From Baseline in Corrected QT (QTc) Interval
C6D1 Predose
|
—
|
6.00 milliseconds
Interval 6.0 to 6.0
|
—
|
171.00 milliseconds
Interval 171.0 to 171.0
|
|
Change From Baseline in Corrected QT (QTc) Interval
C10D1
|
—
|
—
|
—
|
17.00 milliseconds
Interval 17.0 to 17.0
|
|
Change From Baseline in Corrected QT (QTc) Interval
C12D1
|
—
|
—
|
—
|
15.00 milliseconds
Interval 15.0 to 15.0
|
|
Change From Baseline in Corrected QT (QTc) Interval
C14D1
|
—
|
—
|
—
|
25.00 milliseconds
Interval 25.0 to 25.0
|
|
Change From Baseline in Corrected QT (QTc) Interval
C18D1
|
—
|
—
|
—
|
3.00 milliseconds
Interval 3.0 to 3.0
|
Adverse Events
M1069 150 mg BID
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
M1069 300 mg BID
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
M1069 450 mg BID
Serious events: 0 serious events
Other events: 6 other events
Deaths: 1 deaths
M1069 600 mg BID
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
M1069 150 mg BID
n=3 participants at risk
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 150 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 300 mg BID
n=3 participants at risk
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 300 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 450 mg BID
n=6 participants at risk
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 450 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 600 mg BID
n=3 participants at risk
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 600 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/3 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Nervous system disorders
Cerebrovascular accident
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
Other adverse events
| Measure |
M1069 150 mg BID
n=3 participants at risk
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 150 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 300 mg BID
n=3 participants at risk
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 300 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 450 mg BID
n=6 participants at risk
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 450 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
M1069 600 mg BID
n=3 participants at risk
Participants received consecutive 21-day cycles with twice daily oral administration (BID) of M1069 at a dose of 600 miligrams (mg) until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from study intervention.
|
|---|---|---|---|---|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
16.7%
1/6 • Number of events 1 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
16.7%
1/6 • Number of events 1 • Up to 17.3 months
|
33.3%
1/3 • Number of events 2 • Up to 17.3 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
16.7%
1/6 • Number of events 1 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
16.7%
1/6 • Number of events 1 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
16.7%
1/6 • Number of events 1 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
33.3%
1/3 • Number of events 2 • Up to 17.3 months
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/3 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to skin
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
16.7%
1/6 • Number of events 1 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
16.7%
1/6 • Number of events 1 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
16.7%
1/6 • Number of events 1 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/3 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/3 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
33.3%
1/3 • Number of events 2 • Up to 17.3 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
16.7%
1/6 • Number of events 1 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
16.7%
1/6 • Number of events 1 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
16.7%
1/6 • Number of events 1 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
16.7%
1/6 • Number of events 1 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
|
General disorders
Catheter site pain
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 2 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
33.3%
2/6 • Number of events 2 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
16.7%
1/6 • Number of events 1 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
16.7%
1/6 • Number of events 1 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
16.7%
1/6 • Number of events 1 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
16.7%
1/6 • Number of events 1 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Investigations
Lipase increased
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
16.7%
1/6 • Number of events 1 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/3 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/3 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Investigations
Amylase increased
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
16.7%
1/6 • Number of events 1 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
33.3%
1/3 • Number of events 2 • Up to 17.3 months
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
16.7%
1/6 • Number of events 1 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
16.7%
1/6 • Number of events 1 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 2 • Up to 17.3 months
|
66.7%
2/3 • Number of events 3 • Up to 17.3 months
|
16.7%
1/6 • Number of events 1 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
16.7%
1/6 • Number of events 1 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Eye disorders
Retinal degeneration
|
66.7%
2/3 • Number of events 2 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
0.00%
0/3 • Up to 17.3 months
|
0.00%
0/6 • Up to 17.3 months
|
33.3%
1/3 • Number of events 1 • Up to 17.3 months
|
Additional Information
Communication Center
Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place