Trial Outcomes & Findings for LCI-GU-URO-CRI-001: Crizotinib in Patients With c-MET or RON-Positive Metastatic Urothelial Cancer (NCT NCT02612194)

Last Updated: 2022-11-03

Results Overview

Overall response will be determined as the best treatment response for each patient as a binary variable indicating whether or not the patient achieved a Complete Response (CR) or Partial Response (PR) as determined by RECIST v1.1 criteria. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1):Complete Response (CR) is the disappearance of all lesions (target and non target); Partial Response (PR) is at least 30% decrease in the sum of the diameters of target lesions from baseline and no new lesions or unequivocal progression in non target lesions from baseline; Stable Disease (SD) is neither sufficient shrinkage in target lesions to qualify for PR (less than 30% decrease) nor sufficient increase in target lesions (versus smallest sum of diameters) to qualify for PD (less than 20% increase), with no new lesions or unequivocal progression in non target lesions from baseline. For the purposes of response determination, confirmatory scan for CR and PR is required.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

From enrollment to best response while on crizotinib; Subjects remained on treatment until disease progression or death or unacceptable toxicity (subjects were on treatment for an average of 6 weeks)

Results posted on

2022-11-03

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1 c-MET high (\> 50%), RON null (0-9%) Crizotinib: All arms will receive crizotinib.	Cohort 3 c-MET null (0-9%), RON + (10-100%) Crizotinib was administered orally at 250 mg twice daily.
Overall Study STARTED	6	2
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	6	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 c-MET high (\> 50%), RON null (0-9%) Crizotinib: All arms will receive crizotinib.	Cohort 2 c-MET + (10-100%), RON + (10-100%) Crizotinib was administered orally at 250 mg twice daily.	Cohort 3 c-MET null (0-9%), RON + (10-100%) Crizotinib was administered orally at 250 mg twice daily.
Overall Study Death	5	0	2
Overall Study Early Study Termination	1	0	0

Baseline Characteristics

LCI-GU-URO-CRI-001: Crizotinib in Patients With c-MET or RON-Positive Metastatic Urothelial Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=6 Participants c-MET high (\> 50%), RON null (0-9%) Crizotinib: All arms will receive crizotinib.	Cohort 2 c-MET + (10-100%), RON + (10-100%) Crizotinib: All arms will receive crizotinib.	Cohort 3 n=2 Participants c-MET null (0-9%), RON + (10-100%) Crizotinib: All arms will receive crizotinib.	Total n=8 Participants Total of all reporting groups
Age, Continuous	60 years n=5 Participants	—	71.5 years n=5 Participants	62 years n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	—	0 Participants n=5 Participants	2 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	—	2 Participants n=5 Participants	6 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	—	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	—	2 Participants n=5 Participants	8 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	—	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	—	2 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	6 participants n=5 Participants	—	2 participants n=5 Participants	8 participants n=4 Participants
Primary Tumor Site Bladder	5 Participants n=5 Participants	—	1 Participants n=5 Participants	6 Participants n=4 Participants
Primary Tumor Site Other	1 Participants n=5 Participants	—	1 Participants n=5 Participants	2 Participants n=4 Participants
ECOG at Baseline 0	4 Participants n=5 Participants	—	0 Participants n=5 Participants	4 Participants n=4 Participants
ECOG at Baseline 1	2 Participants n=5 Participants	—	2 Participants n=5 Participants	4 Participants n=4 Participants
c-MET Expression, % 0%	0 Participants n=5 Participants	—	1 Participants n=5 Participants	1 Participants n=4 Participants
c-MET Expression, % 1 - 9%	0 Participants n=5 Participants	—	1 Participants n=5 Participants	1 Participants n=4 Participants
c-MET Expression, % 51 - 75%	2 Participants n=5 Participants	—	0 Participants n=5 Participants	2 Participants n=4 Participants
c-MET Expression, % >75%	4 Participants n=5 Participants	—	0 Participants n=5 Participants	4 Participants n=4 Participants
RON Expression, % 0%	2 Participants n=5 Participants	—	0 Participants n=5 Participants	2 Participants n=4 Participants
RON Expression, % 1 - 9%	4 Participants n=5 Participants	—	0 Participants n=5 Participants	4 Participants n=4 Participants
RON Expression, % >75%	0 Participants n=5 Participants	—	2 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: From enrollment to best response while on crizotinib; Subjects remained on treatment until disease progression or death or unacceptable toxicity (subjects were on treatment for an average of 6 weeks)

Population: Study was designed to evaluate objective response rate overall for all enrolled subjects and not separately by molecular cohorts. Efficacy analyses were conducted on the population of subjects who began crizotinib treatment. Analysis of overall response rate was conducted on those patients in the efficacy population with measurable disease present at baseline.

Outcome measures

Outcome measures
Measure	Total Enrolled Study Cohort n=8 Participants This group contains all subjects enrolled on the study, who received crizotinib, pooling the subjects in the three molecularly defined cohorts.
Overall Response	0 Participants

SECONDARY outcome

Timeframe: From date of treatment start to date of death, or censored as described above; assessed for approximately 2 years.

Population: Study was designed to evaluate outcomes overall for all enrolled subjects and not separately by molecular cohorts. Efficacy analyses were conducted on the population of subjects who began crizotinib treatment.

Overall survival was defined as the duration from enrollment date to the date of death from any cause. Subjects who were alive or lost to follow-up at the time of the analysis were censored at the last known date they were alive.

Outcome measures

Outcome measures
Measure	Total Enrolled Study Cohort n=8 Participants This group contains all subjects enrolled on the study, who received crizotinib, pooling the subjects in the three molecularly defined cohorts.
Overall Survival	3.1 months Interval 0.2 to 6.1

SECONDARY outcome

Timeframe: From date of treatment start to date of progression or death, or censored as described above; assessed for approximately 2 years.

PFS was defined as duration of time from enrollment to the study to time of progression or death. Disease progression (PD) can be objectively determined as per RECIST v1.1 (Response Evaluation Criteria in Solid Tumors, where PD is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in non-target lesion, or the appearance of new lesions) or progression can be subjective as determined by the investigator. Evidence for subjective progressions must be documented in medical records. For surviving subjects who do not have documented PD, PFS will be censored at last radiologic assessment. For subjects who receive subsequent anti-cancer therapy prior to documented PD, PFS will be censored at last radiologic assessment prior to commencement of subsequent therapy. Subjects who experience a PFS event following an interval equal to two or more scheduled assessments will be censored at date of last assessment prior to first missed assessment.

Outcome measures

Outcome measures
Measure	Total Enrolled Study Cohort n=8 Participants This group contains all subjects enrolled on the study, who received crizotinib, pooling the subjects in the three molecularly defined cohorts.
Progression Free Survival	1.5 months Interval 0.2 to 1.8

Adverse Events

Cohort 1

Serious events: 2 serious events

Other events: 5 other events

Deaths: 5 deaths

Cohort 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 3

Serious events: 2 serious events

Other events: 2 other events

Deaths: 2 deaths

Total

Serious events: 4 serious events

Other events: 7 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1 n=6 participants at risk c-MET high (\> 50%), RON null (0-9%) Crizotinib: All arms will receive crizotinib.	Cohort 2 c-MET + (10-100%), RON + (10-100%) Crizotinib: All arms will receive crizotinib.	Cohort 3 n=2 participants at risk c-MET null (0-9%), RON + (10-100%) Crizotinib: All arms will receive crizotinib.	Total n=8 participants at risk Pooled Cohorts 1, 2, and 3
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	— 0/0 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	50.0% 1/2 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	12.5% 1/8 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.
Psychiatric disorders Confusion	16.7% 1/6 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	— 0/0 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	0.00% 0/2 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	12.5% 1/8 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.
Gastrointestinal disorders Constipation	0.00% 0/6 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	— 0/0 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	50.0% 1/2 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	12.5% 1/8 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	— 0/0 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	50.0% 1/2 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	12.5% 1/8 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.
General disorders Fever	16.7% 1/6 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	— 0/0 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	0.00% 0/2 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	12.5% 1/8 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/6 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	— 0/0 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	50.0% 1/2 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	12.5% 1/8 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.
Gastrointestinal disorders Nausea	16.7% 1/6 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	— 0/0 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	50.0% 1/2 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	25.0% 2/8 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.
General disorders Pain	16.7% 1/6 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	— 0/0 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	0.00% 0/2 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	12.5% 1/8 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.
Respiratory, thoracic and mediastinal disorders Respiratory failure	16.7% 1/6 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	— 0/0 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	0.00% 0/2 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	12.5% 1/8 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.
Infections and infestations Sepsis	16.7% 1/6 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	— 0/0 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	0.00% 0/2 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.	12.5% 1/8 • Baseline, during treatment, and through 30 days after last dose. Duration of treatment was the time from treatment start until evidence of progressive disease, unacceptable toxicity, Investigator discretion, or consent withdrawal. Note, as there were no subjects enrolled in Cohort 2, the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Adverse Events in Cohort 2 is zero.

Other adverse events

Additional Information

Chair of Biostatistics Department

Levine Cancer Institute

Phone: 9804422371

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place