Trial · NCT00560560

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

NCT00560560, Phase 2, Completed, Pfizer; results first posted 2013-05-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study Using CP-751,871 In Patients With Stage IV Colorectal Cancer That Has Not Responded To Previous Anti-Cancer Treatments. Trials, record NCT00560560. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00560560

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study Using CP-751,871 In Patients With Stage IV Colorectal Cancer That Has Not Responded To Previous Anti-Cancer Treatments
NCT number: NCT00560560
Status: Completed
Phases: Phase 2
Enrollment: 168 participants, actual
Lead sponsor: Pfizer
Conditions: Colorectal Neoplasm
Interventions: CP-751, 871
First posted: 2007-11-19
Last updated: 2013-05-20
Results first posted: 2013-05-09

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Estimate of the 6 Month Survival Probability	Baseline up to Month 6	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.
Secondary	Overall Survival	From date of enrollment until death or censorship, up to 33 months	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.
Secondary	Progression-Free Survival (PFS)	Baseline until tumor progression or censorship, up to 33 months. The frequency of tumor assessments was screening, every cycle, end of treatment (within 28 days of last dose of study drug), and follow-up.	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.
Secondary	Percentage of Participants With Objective Response	Baseline, every cycle (Day 15-21 or according to local standard), end of treatment (within 28 days of last dose of study drug) and follow-up (150 days after last dose of study drug), up to 33 months	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.
Secondary	Descriptive Summary of Figitumumab Concentration Versus Time	Pre-dose on Day 1, 1 hour after end of infusion (post-dose) on Day 2 in Cycle 1, pre-dose on Day 1 in Cycles 2,3,4, 1 hour post-dose on Day 1 in Cycle 5	The measurement of mean plasma concentration of figitumumab in Day 1 of Cycle 1,2,3,4,5
Secondary	Participants Reporting Positive for Total Anti-drug Antibodies (ADA)	Up to 2 hours prior to infusion in Cycles 1 and 4, at the end of treatment, and at the 4th scheduled follow-up visit (~150 days after the last infusion)	The immunogenicity of figitumumab in terms of producing an antidrug antibody (ADA) response were monitored.
Secondary	Counts of Circulating Tumor Cells (CTCs) Expressing Positive Insulin-like Growth Factor 1 Receptor (IGF-1R)	Cycle 1 pre-dosing and Cycle 4 pre-dosing	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.
Secondary	Counts of Circulating Tumor Cells (CTCs)	Cycle 1 pre-dosing and Cycle 4 pre-dosing	The quantification of circulating tumor cells (CTCs)in this patient population. Blood samples were collected, and were measured using an automated microscope system.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Estimate of the 6 Month Survival Probability	Baseline up to Month 6	All enrolled participants.	Percent chance of survival	NUMBER
SECONDARY	Overall Survival	From date of enrollment until death or censorship, up to 33 months	All enrolled participants.	Months	MEDIAN
SECONDARY	Progression-Free Survival (PFS)	Baseline until tumor progression or censorship, up to 33 months. The frequency of tumor assessments was screening, every cycle, end of treatment (within 28 days of last dose of study drug), and follow-up.	All enrolled participants.	months	MEDIAN
SECONDARY	Percentage of Participants With Objective Response	Baseline, every cycle (Day 15-21 or according to local standard), end of treatment (within 28 days of last dose of study drug) and follow-up (150 days after last dose of study drug), up to 33 months	Per protocol. All enrolled participants who started treatment, with measurable disease and adequate baseline assessment.	Percentage of participants	NUMBER
SECONDARY	Descriptive Summary of Figitumumab Concentration Versus Time	Pre-dose on Day 1, 1 hour after end of infusion (post-dose) on Day 2 in Cycle 1, pre-dose on Day 1 in Cycles 2,3,4, 1 hour post-dose on Day 1 in Cycle 5	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.	miligrams/liter (mg/L)	MEAN
SECONDARY	Participants Reporting Positive for Total Anti-drug Antibodies (ADA)	Up to 2 hours prior to infusion in Cycles 1 and 4, at the end of treatment, and at the 4th scheduled follow-up visit (~150 days after the last infusion)	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.
SECONDARY	Counts of Circulating Tumor Cells (CTCs) Expressing Positive Insulin-like Growth Factor 1 Receptor (IGF-1R)	Cycle 1 pre-dosing and Cycle 4 pre-dosing	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.	number of CTC expressing IGF-1R/ml blood	MEDIAN
SECONDARY	Counts of Circulating Tumor Cells (CTCs)	Cycle 1 pre-dosing and Cycle 4 pre-dosing	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.	Number of CTC/ml of blood	MEDIAN

Source ClinicalTrials.gov

Results by group26

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Estimate of the 6 Month Survival Probability	Figitumumab 20 mg/kg		49.4	95% Confidence Interval 38.8 to 60.0	Percent chance of survival
Estimate of the 6 Month Survival Probability	Figitumumab 30 mg/kg		44.1	95% Confidence Interval 33.4 to 54.9	Percent chance of survival
Overall Survival	Figitumumab 20 mg/kg		5.8	95% Confidence Interval 4.3 to 7.1	Months
Overall Survival	Figitumumab 30 mg/kg		5.6	95% Confidence Interval 4.1 to 6.9	Months
Progression-Free Survival (PFS)	Figitumumab 20 mg/kg		1.4	95% Confidence Interval 1.3 to 1.8	months
Progression-Free Survival (PFS)	Figitumumab 30 mg/kg		1.4	95% Confidence Interval 1.3 to 1.7	months
Percentage of Participants With Objective Response	Figitumumab 20 mg/kg		0	95% Confidence Interval 0.0 to 4.8	Percentage of participants
Percentage of Participants With Objective Response	Figitumumab 30 mg/kg		0	95% Confidence Interval 0.0 to 4.5	Percentage of participants
Descriptive Summary of Figitumumab Concentration Versus Time	Figitumumab 20 mg/kg	Cycle1/Day2	647.0	Standard Deviation 288.23	miligrams/liter (mg/L)
Descriptive Summary of Figitumumab Concentration Versus Time	Figitumumab 30 mg/kg	Cycle1/Day2	877.7	Standard Deviation 230.22	miligrams/liter (mg/L)

1 to 10 of 26Source ClinicalTrials.gov

See all 26 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Figitumumab 20 mg/kg	85
Overall Study	STARTED	Figitumumab 30 mg/kg	83
Overall Study	COMPLETED	Figitumumab 20 mg/kg	0
Overall Study	COMPLETED	Figitumumab 30 mg/kg	0
Overall Study	NOT COMPLETED	Figitumumab 20 mg/kg	85
Overall Study	NOT COMPLETED	Figitumumab 30 mg/kg	83

Source ClinicalTrials.gov

Adverse events656

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Figitumumab 20 mg/kg	9	85
other	Anaemia	Blood and lymphatic system disorders	Figitumumab 30 mg/kg	6	83
other	Neutropenia	Blood and lymphatic system disorders	Figitumumab 20 mg/kg	4	85
other	Neutropenia	Blood and lymphatic system disorders	Figitumumab 30 mg/kg	0	83
other	Thrombocytopenia	Blood and lymphatic system disorders	Figitumumab 20 mg/kg	1	85
other	Thrombocytopenia	Blood and lymphatic system disorders	Figitumumab 30 mg/kg	3	83
other	Coagulopathy	Blood and lymphatic system disorders	Figitumumab 20 mg/kg	0	85
other	Coagulopathy	Blood and lymphatic system disorders	Figitumumab 30 mg/kg	1	83
other	Heparin-induced thrombocytopenia	Blood and lymphatic system disorders	Figitumumab 20 mg/kg	0	85
other	Heparin-induced thrombocytopenia	Blood and lymphatic system disorders	Figitumumab 30 mg/kg	1	83

1 to 10 of 656Source ClinicalTrials.gov

See all 656 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Figitumumab 20 mg/kg
Total, all-cause mortality	Figitumumab 30 mg/kg
Total, other adverse events	Figitumumab 20 mg/kg	85	85
Total, other adverse events	Figitumumab 30 mg/kg	83	83
Total, serious adverse events	Figitumumab 20 mg/kg	56	85
Total, serious adverse events	Figitumumab 30 mg/kg	53	83

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Figitumumab 20 mg/kg vs Figitumumab 30 mg/kg: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00560560

GET https://conductscience.org/api/trials/v1/NCT00560560/results?page=2

API reference For AI assistants