Trial Outcomes & Findings for Pembrolizumab Alone or Sequentially Following Single Fraction Non-ablative Radiation to One of the Target Lesions, in Previously Treated Patients With Stage IV NSCLC (NCT NCT02658097)
NCT ID: NCT02658097
Last Updated: 2024-05-03
Results Overview
The Best Overall Response is the best response recorded from the start of the treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The anti-tumor activity will be evaluated as an efficacy endpoints based on radiographic (CT or PET/CT). RECIST 1.1 will be applied for evaluation of tumor response. RECIST 1.1 criteria are as follows: Complete Response (CR) is defined as the disappearance of all lesions and pathologic lymph nodes; Partial Response (PR) is ≥ 30% decrease in sum of diameters with no new lesions, no progression of non-target lesions; Stable disease(SD) is defined as no PR - no progressive disease; and Progressive Disease (PD) is defined as ≥ 20% increase compared to smallest sum of diameters in study or progression of non-target lesions or new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
From first visit to disease progression, up to 24 months after beginning treatment
Results posted on
2024-05-03
Participant Flow
Participant milestones
| Measure |
Single Fraction Radiation Therapy (SFRT) + Pembrolizumab
200mg Pembrolizumab by IV infusion on day 1 of each 3 week cycle. 8Gy will be given in a single fraction on the first day of treatment
Pembrolizumab: 200mg Pembrolizumab by IV infusion
Single Fraction Radiation Therapy: 8Gy radiation therapy will be given in a single fraction on the first day of treatment
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab Alone or Sequentially Following Single Fraction Non-ablative Radiation to One of the Target Lesions, in Previously Treated Patients With Stage IV NSCLC
Baseline characteristics by cohort
| Measure |
Single Fraction Radiation Therapy (SFRT) + Pembrolizumab
n=13 Participants
200mg Pembrolizumab by IV infusion on day 1 of each 3 week cycle. 8Gy will be given in a single fraction on the first day of treatment
Pembrolizumab: 200mg Pembrolizumab by IV infusion
Single Fraction Radiation Therapy: 8Gy radiation therapy will be given in a single fraction on the first day of treatment
|
|---|---|
|
Age, Customized
40-49 years of age
|
0 Participants
n=99 Participants
|
|
Age, Customized
50-59 years of age
|
2 Participants
n=99 Participants
|
|
Age, Customized
60-69 years of age
|
3 Participants
n=99 Participants
|
|
Age, Customized
70-79 years of age
|
7 Participants
n=99 Participants
|
|
Age, Customized
80-89 years of age
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=99 Participants
|
|
Former Smoker
Former Smoker
|
13 Participants
n=99 Participants
|
|
Former Smoker
Non-smoker
|
0 Participants
n=99 Participants
|
|
Prior Treatment
1 prior treatment
|
8 Participants
n=99 Participants
|
|
Prior Treatment
2 prior treatments
|
3 Participants
n=99 Participants
|
|
Prior Treatment
3 prior treatments
|
2 Participants
n=99 Participants
|
|
Types of prior treatments
Carboplatin/Abraxane
|
1 number of prior treatments
n=99 Participants
|
|
Types of prior treatments
Carboplatin/Pemetrexed
|
5 number of prior treatments
n=99 Participants
|
|
Types of prior treatments
Cisplatin/Alimta
|
1 number of prior treatments
n=99 Participants
|
|
Types of prior treatments
ETOPOSIDE / CARBOPLATIN 21 DAY
|
1 number of prior treatments
n=99 Participants
|
|
Types of prior treatments
Maintenance Pemetrexed
|
4 number of prior treatments
n=99 Participants
|
|
Types of prior treatments
Pemetrexed + Bevacizumab
|
1 number of prior treatments
n=99 Participants
|
|
Types of prior treatments
Rucaparib
|
2 number of prior treatments
n=99 Participants
|
|
Types of prior treatments
SBRT
|
1 number of prior treatments
n=99 Participants
|
|
Sites of Metastatic Disease
Bone site
|
5 number of sites
n=99 Participants
|
|
Sites of Metastatic Disease
Lung site
|
1 number of sites
n=99 Participants
|
|
Sites of Metastatic Disease
Lymph Nodes site
|
8 number of sites
n=99 Participants
|
|
Sites of Other Metastatic Disease
Adrenal Gland site
|
5 number of sites
n=99 Participants
|
|
Sites of Other Metastatic Disease
Contralateral lung site
|
7 number of sites
n=99 Participants
|
|
Sites of Other Metastatic Disease
Kidney site
|
1 number of sites
n=99 Participants
|
|
Sites of Other Metastatic Disease
L supreaspinatus muscle site
|
2 number of sites
n=99 Participants
|
|
Sites of Other Metastatic Disease
Mediastinal LN site
|
3 number of sites
n=99 Participants
|
|
Sites of Other Metastatic Disease
Pleura site
|
2 number of sites
n=99 Participants
|
|
Sites of Other Metastatic Disease
Retoperitoneal LNs site
|
2 number of sites
n=99 Participants
|
|
Sites of Other Metastatic Disease
Rib site
|
1 number of sites
n=99 Participants
|
PRIMARY outcome
Timeframe: From first visit to disease progression, up to 24 months after beginning treatmentThe Best Overall Response is the best response recorded from the start of the treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The anti-tumor activity will be evaluated as an efficacy endpoints based on radiographic (CT or PET/CT). RECIST 1.1 will be applied for evaluation of tumor response. RECIST 1.1 criteria are as follows: Complete Response (CR) is defined as the disappearance of all lesions and pathologic lymph nodes; Partial Response (PR) is ≥ 30% decrease in sum of diameters with no new lesions, no progression of non-target lesions; Stable disease(SD) is defined as no PR - no progressive disease; and Progressive Disease (PD) is defined as ≥ 20% increase compared to smallest sum of diameters in study or progression of non-target lesions or new lesions.
Outcome measures
| Measure |
Single Fraction Radiation Therapy (SFRT) + Pembrolizumab
n=13 Participants
200mg Pembrolizumab by IV infusion on day 1 of each 3 week cycle. 8Gy will be given in a single fraction on the first day of treatment
Pembrolizumab: 200mg Pembrolizumab by IV infusion
Single Fraction Radiation Therapy: 8Gy radiation therapy will be given in a single fraction on the first day of treatment
|
|---|---|
|
Number of Patients With Each Response as Measured by RECIST 1.1
Complete Response
|
0 Participants
|
|
Number of Patients With Each Response as Measured by RECIST 1.1
Partial Response
|
4 Participants
|
|
Number of Patients With Each Response as Measured by RECIST 1.1
Progressive Disease
|
2 Participants
|
|
Number of Patients With Each Response as Measured by RECIST 1.1
Stable Disease
|
5 Participants
|
|
Number of Patients With Each Response as Measured by RECIST 1.1
Not Evaluable
|
2 Participants
|
SECONDARY outcome
Timeframe: From first visit to disease progression, up to 24 months after beginning treatmentProgression free survival, PFS is defined as the time from initiation of study drug post-SFRT, until the first documented, confirmed progression of disease. PFS will also be measured and report from the initiation of study drug, pre-SFRT.
Outcome measures
| Measure |
Single Fraction Radiation Therapy (SFRT) + Pembrolizumab
n=13 Participants
200mg Pembrolizumab by IV infusion on day 1 of each 3 week cycle. 8Gy will be given in a single fraction on the first day of treatment
Pembrolizumab: 200mg Pembrolizumab by IV infusion
Single Fraction Radiation Therapy: 8Gy radiation therapy will be given in a single fraction on the first day of treatment
|
|---|---|
|
Median Time of Progression Free Survival
|
3.5 months
Interval 1.4 to
N/A implies Not Reached; the upper side of the confidence interval has not been reached by the end of the follow up period.
|
SECONDARY outcome
Timeframe: From first visit to disease progression, up to 24 months after beginning treatmentOverall Survival, OS will be measure from the initiation of study therapy
Outcome measures
| Measure |
Single Fraction Radiation Therapy (SFRT) + Pembrolizumab
n=13 Participants
200mg Pembrolizumab by IV infusion on day 1 of each 3 week cycle. 8Gy will be given in a single fraction on the first day of treatment
Pembrolizumab: 200mg Pembrolizumab by IV infusion
Single Fraction Radiation Therapy: 8Gy radiation therapy will be given in a single fraction on the first day of treatment
|
|---|---|
|
Median Time of Overall Survival
|
9.2 months
Interval 2.6 to
N/A implies Not Reached; the upper side of the confidence interval has not been reached by the end of the follow up period.
|
SECONDARY outcome
Timeframe: From first visit to disease progression, up to 24 months after beginning treatmentLocal Control with SFRT: The target lesion selected for SFRT will be followed for local control. For the purpose of the study, local control will be defined as a complete response, partial response, or stable disease within the planning target volume.
Outcome measures
| Measure |
Single Fraction Radiation Therapy (SFRT) + Pembrolizumab
n=13 Participants
200mg Pembrolizumab by IV infusion on day 1 of each 3 week cycle. 8Gy will be given in a single fraction on the first day of treatment
Pembrolizumab: 200mg Pembrolizumab by IV infusion
Single Fraction Radiation Therapy: 8Gy radiation therapy will be given in a single fraction on the first day of treatment
|
|---|---|
|
Number of Patients With Local Control of Disease With SFRT
|
9 Participants
|
SECONDARY outcome
Timeframe: From first visit to disease progression, up to 24 months after beginning treatmentLocal Control with SFRT: The target lesion selected for SFRT will be followed for local control. For the purpose of the study, local control will be defined as a complete response, partial response, or stable disease within the planning target volume. The duration of local control will be measured from the time of SBRT treatment fraction.
Outcome measures
| Measure |
Single Fraction Radiation Therapy (SFRT) + Pembrolizumab
n=13 Participants
200mg Pembrolizumab by IV infusion on day 1 of each 3 week cycle. 8Gy will be given in a single fraction on the first day of treatment
Pembrolizumab: 200mg Pembrolizumab by IV infusion
Single Fraction Radiation Therapy: 8Gy radiation therapy will be given in a single fraction on the first day of treatment
|
|---|---|
|
Duration of Local Control of Disease With SFRT
|
13 months
Standard Deviation 11
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From first visit to 30 days after disease progression, up to 25 months after beginning treatmentFor patients receiving SFRT to lung lesions, the development of grade 3 or greater pneumonitis that is probably or definitely attributable to either SFRT or pembrolizumab within the follow-up period will be monitored
Outcome measures
| Measure |
Single Fraction Radiation Therapy (SFRT) + Pembrolizumab
n=13 Participants
200mg Pembrolizumab by IV infusion on day 1 of each 3 week cycle. 8Gy will be given in a single fraction on the first day of treatment
Pembrolizumab: 200mg Pembrolizumab by IV infusion
Single Fraction Radiation Therapy: 8Gy radiation therapy will be given in a single fraction on the first day of treatment
|
|---|---|
|
Number of Patients With Pneumonitis
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From first visit to 30 days post treatment, up to 25 monthsFrom first visit to disease progression, up to 25 months after beginning treatment. Median (95% CI) overall survival by PD-L1 status in months.
Outcome measures
| Measure |
Single Fraction Radiation Therapy (SFRT) + Pembrolizumab
n=13 Participants
200mg Pembrolizumab by IV infusion on day 1 of each 3 week cycle. 8Gy will be given in a single fraction on the first day of treatment
Pembrolizumab: 200mg Pembrolizumab by IV infusion
Single Fraction Radiation Therapy: 8Gy radiation therapy will be given in a single fraction on the first day of treatment
|
|---|---|
|
Changes in PD-L1
Negative PD-L Status
|
7.1 months
Interval 4.7 to
N/A implies Not Reached; the upper side of the confidence interval has not been reached by the end of the follow up period.
|
|
Changes in PD-L1
Positive PD-L Status
|
13 months
Interval 2.1 to
N/A implies Not Reached; the upper side of the confidence interval has not been reached by the end of the follow up period.
|
Adverse Events
Single Fraction Radiation Therapy (SFRT) + Pembrolizumab
Serious events: 5 serious events
Other events: 10 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Single Fraction Radiation Therapy (SFRT) + Pembrolizumab
n=13 participants at risk
200mg Pembrolizumab by IV infusion on day 1 of each 3 week cycle. 8Gy will be given in a single fraction on the first day of treatment
Pembrolizumab: 200mg Pembrolizumab by IV infusion
Single Fraction Radiation Therapy: 8Gy radiation therapy will be given in a single fraction on the first day of treatment
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Nervous system disorders
Edema Cerebral
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
General disorders
Death NOS
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
General disorders
Fever
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Psychiatric disorders
Confusion
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Injury, poisoning and procedural complications
Fall
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Renal and urinary disorders
Acute kidney injury
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Respiratory, thoracic and mediastinal disorders
Respitory Failure
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Gastrointestinal disorders
Colitis
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Nervous system disorders
Syncope
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
Other adverse events
| Measure |
Single Fraction Radiation Therapy (SFRT) + Pembrolizumab
n=13 participants at risk
200mg Pembrolizumab by IV infusion on day 1 of each 3 week cycle. 8Gy will be given in a single fraction on the first day of treatment
Pembrolizumab: 200mg Pembrolizumab by IV infusion
Single Fraction Radiation Therapy: 8Gy radiation therapy will be given in a single fraction on the first day of treatment
|
|---|---|
|
General disorders
Fatigue
|
30.8%
4/13 • Number of events 5 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
46.2%
6/13 • Number of events 8 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Blood and lymphatic system disorders
Anemia
|
38.5%
5/13 • Number of events 6 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Gastrointestinal disorders
Esophagitis
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal Mucositis
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
1/13 • Number of events 2 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Endocrine disorders
Hypothyroidism
|
15.4%
2/13 • Number of events 2 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
38.5%
5/13 • Number of events 5 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
15.4%
2/13 • Number of events 2 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Nervous system disorders
Dysphasia
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Investigations
White blood cell decrease
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Gastrointestinal disorders
Dry Mouth
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Gastrointestinal disorders
Nausea
|
15.4%
2/13 • Number of events 2 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Injury, poisoning and procedural complications
Fall
|
15.4%
2/13 • Number of events 2 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Nervous system disorders
Seizure
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Nervous system disorders
Memory impairment
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Nervous system disorders
Encephalopathy
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Investigations
Lymphocyte count decreased
|
30.8%
4/13 • Number of events 4 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Investigations
Alkaline phosphatase increased
|
15.4%
2/13 • Number of events 2 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
7.7%
1/13 • Number of events 2 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
General disorders
Edema limbs
|
15.4%
2/13 • Number of events 3 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Investigations
Creatinine increased
|
15.4%
2/13 • Number of events 6 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Metabolism and nutrition disorders
Anorexia
|
15.4%
2/13 • Number of events 3 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Gastrointestinal disorders
Dysphagia
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
23.1%
3/13 • Number of events 5 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Nervous system disorders
Dizziness
|
15.4%
2/13 • Number of events 6 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Gastrointestinal disorders
Diarrhea
|
15.4%
2/13 • Number of events 2 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
2/13 • Number of events 3 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Investigations
Aspartate aminotransferase increased
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Infections and infestations
Lung Infection
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Nervous system disorders
Stroke
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Investigations
Platelet count decreased
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
15.4%
2/13 • Number of events 3 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.7%
1/13 • Number of events 2 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Investigations
Weight Loss
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
7.7%
1/13 • Number of events 2 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
|
Infections and infestations
Sinusitis
|
7.7%
1/13 • Number of events 1 • Adverse events were collected up until 30 days after the final dose of study drug was administered to each participant.
|
Additional Information
Dr. Nathan Pennell
Cleveland Clinic, Case Comprehensive Cancer Center
Phone: 1-866-223 8100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place