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

Roche

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: Paclitaxel + Carboplatin + CP-870,893

Study type: Interventional

Funder types: Industry

Identifiers

NCT00607048

A5021004

Details and patient eligibility

About

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

Enrollment: 34 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Schedule A

Other group

Description:

Schedule A (CP-870,893 administration schedule)

Treatment:

Drug: Paclitaxel + Carboplatin + CP-870,893

Drug: Paclitaxel + Carboplatin + CP-870,893

Schedule B

Other group

Description:

Schedule B (CP-870,893 administration schedule)

Treatment:

Drug: Paclitaxel + Carboplatin + CP-870,893

Drug: Paclitaxel + Carboplatin + CP-870,893