Dose Finding Study Of CP-870,893, An Immune System Stimulating Antibody, In Combination With Paclitaxel And Carboplatin For Patients With Metastatic Solid Tumors

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-07-31

Brief Summary

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This is a dose-finding study; therefore, there is no hypothesis testing

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Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Schedule A

Schedule A (CP-870,893 administration schedule)

Group Type OTHER

Paclitaxel + Carboplatin + CP-870,893

Intervention Type DRUG

Paclitaxel is administered intravenously on day 1 of a 21-day cycle at a dose of 175 mg/m\^2. Carboplatin is administered intravenously on day 1 of a 21-day cycle at AUC 6. CP-870,893 is administered intravenously on DAY 3 of a 21-day cycle in escalating doses (0.1 mg/kg and 0.2 mg/kg)

Schedule B

Schedule B (CP-870,893 administration schedule)

Group Type OTHER

Paclitaxel + Carboplatin + CP-870,893

Intervention Type DRUG

Paclitaxel is administered intravenously on day 1 of a 21-day cycle at a dose of 175 mg/m\^2. Carboplatin is administered intravenously on day 1 of a 21-day cycle at AUC 6. CP-870,893 is administered intravenously on DAY 8 of a 21-day cycle in escalating doses (0.1 mg/kg and 0.2 mg/kg)

Interventions

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Paclitaxel + Carboplatin + CP-870,893

Paclitaxel is administered intravenously on day 1 of a 21-day cycle at a dose of 175 mg/m\^2. Carboplatin is administered intravenously on day 1 of a 21-day cycle at AUC 6. CP-870,893 is administered intravenously on DAY 3 of a 21-day cycle in escalating doses (0.1 mg/kg and 0.2 mg/kg)

Intervention Type DRUG

Paclitaxel + Carboplatin + CP-870,893

Paclitaxel is administered intravenously on day 1 of a 21-day cycle at a dose of 175 mg/m\^2. Carboplatin is administered intravenously on day 1 of a 21-day cycle at AUC 6. CP-870,893 is administered intravenously on DAY 8 of a 21-day cycle in escalating doses (0.1 mg/kg and 0.2 mg/kg)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with metastatic solid tumors, for whom carboplatin and paclitaxel are appropriate;
* Patients \>18 years of age;
* Good performance status;
* Adequate bone marrow and organ function

Exclusion Criteria

* Previous treatment with any other compound that targets CD40
* Current or planned concurrent treatment with any anticancer agent;
* Patients who have received bone marrow transplant;
* History of autoimmune disorder
* History (within the previous year) of heart failure or heart attack
* Cancer-associated coagulation disorders

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No