Study Complete
Sponsor ID
20060332

Conatumumab/Panitumumab Combination Metastatic Colorectal Cancer study

Sponsor ID
20060332
Clinicaltrials.gov ID
NCT00630786
EUCTIS ID
N/A
EudraCT ID
2007-004722-25

Study Details

This is an exploratory phase 1b/2, global, multicenter, single-arm, 2-part (phase 1b and 2) study of conatumumab in combination with panitumumab in patients with Metastatic Colorectal Cancer.

Additional Study Details

Phase
Phase 1/Phase 2
Product
panitumumab
Type
Interventional
Masking
None (Open Label)
Enrollment
53
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Participants with an Objective Response

Timeframe: Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment. The mean follow-up time was 35.7 weeks.

Part 1: Number of participants with Dose-limiting Toxicities

Timeframe: 4 weeks

Secondary Outcome Measures

Progression-free Survival

Timeframe: Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment. The mean follow-up time was 35.7 weeks.

Overall survival

Timeframe: Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment. The mean follow-up time was 35.7 weeks.

Number of Participants with Disease control

Timeframe: Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment. The mean follow-up time was 35.7 weeks.

Time to Response

Timeframe: Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment. The mean follow-up time was 35.7 weeks.

Duation of Response

Timeframe: Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment. The mean follow-up time was 35.7 weeks.

Number of participants with anti-therapeutic antibodies

Timeframe: Antibody samples were collected at weeks 1, 7, and 23 and every 6 months thereafter during treatment, and at the safety follow-up and follow-up visits. The mean follow-up time was 35.7 weeks.

Number of Participants with Adverse Events (AEs)

Timeframe: From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks.

Number of Participants with Post-baseline Laboratory Values Grade 3 or Higher

Timeframe: From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks.

Study Documents

Study Synopsis
Available Language(s): English

Locations

No locations found.