Trial Outcomes & Findings for Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer (NCT NCT00006046)
NCT ID: NCT00006046
Last Updated: 2023-10-04
Results Overview
Toxicity was graded in accordance with the Common Toxicity Scale developed by NCI (1998) where Grade 1 represents the lowest toxicity grade and Grade 5 death. Dose-limiting toxicity (DLT) was defined as Grade 3 and Grade 4 adverse events which were at least possibly related to study treatment.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
7 participants
Primary outcome timeframe
up to 10 weeks.
Results posted on
2023-10-04
Participant Flow
Seven patients were entered into the 10mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
Participant milestones
| Measure |
Hu3S193 10 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
Hu3S193 25 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
Hu3S193 50 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
Hu3S193 100 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
Hu3S193 200 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Hu3S193 10 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
Hu3S193 25 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
Hu3S193 50 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
Hu3S193 100 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
Hu3S193 200 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
0
|
0
|
0
|
|
Overall Study
Disease Progression
|
2
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Hu3S193 10 mg/m2
n=7 Participants
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
Hu3S193 25 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
Hu3S193 50 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
Hu3S193 100 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
Hu3S193 200 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
6 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
1 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
4 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
3 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
2 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
5 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
7 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
—
|
—
|
—
|
—
|
7 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: up to 10 weeks.Population: All patients who entered the study.
Toxicity was graded in accordance with the Common Toxicity Scale developed by NCI (1998) where Grade 1 represents the lowest toxicity grade and Grade 5 death. Dose-limiting toxicity (DLT) was defined as Grade 3 and Grade 4 adverse events which were at least possibly related to study treatment.
Outcome measures
| Measure |
Hu3S193 10 mg/m2
n=7 Participants
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
Hu3S193 25 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
Hu3S193 50 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
Hu3S193 100 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
Hu3S193 200 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
|---|---|---|---|---|---|
|
Number of Patients With Dose-limiting Toxicities (DLTs)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: All patients who entered the study and had tumor assessments.
Complete response (CR); disappearance of all measurable disease lasting a minimum of 4 weeks. Partial Response (PR); 50% or greater decrease in the sum of the products of the perpendicular diameters or all measurable lesions, without development of new lesions or increase in size of any lesion, lasting a minimum of 4 weeks. Progressive disease (PD); Appearance of new lesions or increase by 25% or more in size of any measurable lesion. Stable disease (SD); Not meeting criteria for response or progression.
Outcome measures
| Measure |
Hu3S193 10 mg/m2
n=4 Participants
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
Hu3S193 25 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
Hu3S193 50 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
Hu3S193 100 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
Hu3S193 200 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
|---|---|---|---|---|---|
|
Number of Patients With Tumor Responses
CR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Tumor Responses
PR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Tumor Responses
SD
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Tumor Responses
PD
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Hu3S193 10 mg/m2
Serious events: 5 serious events
Other events: 3 other events
Deaths: 0 deaths
Hu3S193 25 mg/m2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hu3S193 50 mg/m2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hu3S193 100 mg/m2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hu3S193 200 mg/m2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hu3S193 10 mg/m2
n=7 participants at risk
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
Hu3S193 25 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
Hu3S193 50 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
Hu3S193 100 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
Hu3S193 200 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
|---|---|---|---|---|---|
|
Infections and infestations
Actinomycosis
|
14.3%
1/7 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
28.6%
2/7 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.3%
1/7 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
14.3%
1/7 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
Other adverse events
| Measure |
Hu3S193 10 mg/m2
n=7 participants at risk
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
Hu3S193 25 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
Hu3S193 50 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
Hu3S193 100 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
Hu3S193 200 mg/m2
Hu3S193 was administered weekly for 8 consecutive weeks. The antibody was diluted in physiologic saline containing 5% human serum albumin and infused intravenously at a maximum rate of 100 mg/hour. If patients were stable or responding, they were eligible to receive 8-week maintenance cycles of hu3S193 at 10 mg/m2 starting in week 10 and continuing until progression.
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
|
Musculoskeletal and connective tissue disorders
Chills
|
14.3%
1/7 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
|
General disorders
Pyrexia
|
14.3%
1/7 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor hemorrhage
|
14.3%
1/7 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
|
Infections and infestations
Viral infection
|
14.3%
1/7 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
—
0/0 • up to 10 weeks
Adverse Events (AEs) were collected on the adverse event page of the Case Report Form (CRF). AEs were graded in accordance with the Common Toxicity Scale developed by NCI (1998). Seven patients were entered into the 10 mg/m2 dose cohort. No patients were entered into the other cohorts as the study was terminated due to poor recruitment.
|
Additional Information
Jonathan Skipper PhD
Ludwig Institute for Cancer Research
Phone: 12124501539
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place