CP-751,871 In Combination With Docetaxel In Advance Non-hematologic Malignancies

NCT ID: NCT01653158

Last Updated: 2013-10-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2009-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This clinical trial is designed to determine the safety, tolerability, pharmacokinetics and pharmacodynamic effects of escalating doses of CP 751,871 given in combination with docetaxel in patients with non-hematologic malignancies for whom docetaxel is a reasonable treatment option.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Non-Hematologic Malignancies

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

non-hematologic cancer advanced solid tumors prostrate cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CP-751,871 combined with docetaxel

Group Type EXPERIMENTAL

CP-751,871

Intervention Type DRUG

CP-751,871 was given intravenously \[IV\] every 3 weeks in escalating doses ranging from 0.1 mg/kg up to 20 mg/kg.

Standard doses of Docetaxel were given every 3 weeks with CP-751,871. Study therapy was continued until disease progression, lack of tolerability for up to 17 cycles (approximately 1 year).

Docetaxel

Intervention Type DRUG

Docetaxel up to 75 mg/m\^2 was administered intravenously \[IV\] on Day 1 of each 3-week dosing cycle.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CP-751,871

CP-751,871 was given intravenously \[IV\] every 3 weeks in escalating doses ranging from 0.1 mg/kg up to 20 mg/kg.

Standard doses of Docetaxel were given every 3 weeks with CP-751,871. Study therapy was continued until disease progression, lack of tolerability for up to 17 cycles (approximately 1 year).

Intervention Type DRUG

Docetaxel

Docetaxel up to 75 mg/m\^2 was administered intravenously \[IV\] on Day 1 of each 3-week dosing cycle.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age greater than 18 years
* Documented advanced-stage non-hematologic malignancy for whom docetaxel monotherapy is a reasonable treatment option
* Eastern Cooperative Oncology Group \[ECOG\] performance status 0-1

Exclusion Criteria

* Significant active cardiac disease
* Chemotherapy, biological or investigational agents within 4 weeks prior to dosing
* Inadequate bone marrow, renal, cardiac or liver function
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Sutton, Surrey, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A4021003

Identifier Type: -

Identifier Source: org_study_id