Neoplasms

All Conditions

Digestive System Diseases

Adenocarcinoma

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

All Drugs and Chemicals

Herbal and Botanical

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Cola

Human IgG2 Monoclonal Antibody. 20mg/kg or 30 mg/kg every 3 weeks for 17 cycles, until progression or unacceptable toxicity develops.

CP-751, 871

Pfizer CT.gov Call Center

This study will test if there is any survival benefit in patients with refractory metastatic colorectal cancer that receive CP-751, 871.

Study Using CP-751,871 In Patients With Stage IV Colorectal Cancer That Has Not Responded To Previous Anti-Cancer Treatments

A Phase II, Single Arm Study Of CP-751,871 In Patients With Refractory Metastatic Adenocarcinoma Of The Colon Or Rectum

The 6 month survival probability was defined as the probability of survival at 6 months based on the Kaplan-Meier estimate. The time was from date of enrollment to date of death due to any cause. For participants who were last known to be alive, overall survival was censored at the last contact date.

The time from date of enrollment to date of death due to any cause. For participants who were last known to be alive, overall survival was censored at the last contact date.

The period from study entry until disease progression. Participants without progression or death were censored at time of last disease assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as 20% increase in the sum of longest diameters of target measurable lesions, or a clear increase in a non-target lesion, or the apprearance of new lesions.

Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target and non-target disease. PR applied only to participants with at least one measurable lesion. Greater than or equal to 30 % decrease under baseline of the sum of longest diameters of all target measurable lesions.

The measurement of mean plasma concentration of figitumumab in Day 1 of Cycle 1,2,3,4,5

The immunogenicity of figitumumab in terms of producing an antidrug antibody (ADA) response were monitored.

The quantification of circulating tumor cells (CTCs) expressing the IGF-1R in this patient population. Blood samples were collected, and were measured using an automated microscope system.

The quantification of circulating tumor cells (CTCs)in this patient population. Blood samples were collected, and were measured using an automated microscope system.

Pfizer

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.

Figitumumab 20 mg/kg

Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.

Figitumumab 30 mg/kg

Total

<65 years

>=65 years

Age, Customized

Sex: Female, Male

Pfizer ClinicalTrials.gov Call Center

The hypotheses for each group were H0:p=0.45 vs H1:p\>0.45. There was one interim analysis for futility for each group based on the method of Case and Morgan. The futility boundary was not crossed for 20/kg mg group, but was crossed for the 30/kg mg group. It was recommended to investigators that participants be discontinued from treatment with 30 mg/kg of figitumumab.

Estimate of the 6 Month Survival Probability

Overall Survival

Progression-Free Survival (PFS)

Per protocol. All enrolled participants who started treatment, with measurable disease and adequate baseline assessment.

Percentage of Participants With Objective Response

Cycle1/Day2

Cycle2/Day1

Cycle3/Day1

Cycle4/Day1

CYcle5/Day1

All participants for whom PK was assessed at least once. The numbers of participants analyzed are numbers of observation (non-missing concentrations). The numbers for 20 mg/kg group are 84,7,3,2,13 for five cycles, respectively. The numbers for 30 mg/kg group are 79,8,2,2,8 for five cycles, respectively.

Descriptive Summary of Figitumumab Concentration Versus Time

Participants for whom at least one ADA measurement was done. The outcome was not analyzed and only listing of ADA level for each participant was available.

Participants Reporting Positive for Total Anti-drug Antibodies (ADA)

Pre-treatment and/or baseline (n=44,71)

Post-Baseline and/or follow-up (n=18,17)

All enrolled participants who started treatment and who have at least one sample submitted. The total number of participants for this outcome measure was less than the original population. "N" means the numbers of units analyzed in Pre-treatment and/or Baseline, and Post-Baseline and/or Follow-up, respectively.

Spots Global Cancer Trial Database for Study Using CP-751,871 In Patients With Stage IV Colorectal Cancer That Has Not Responded To Previous Anti-Cancer Treatments

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial