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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Advanced Non-Hematologic Malignancies

Treatments: Drug: Docetaxel; Drug: CP-751,871

Study type: Interventional

Funder types: Industry

Identifiers

NCT01653158

A4021003

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

CP-751,871 combined with docetaxel

Experimental group

Treatment:

Drug: Docetaxel

Drug: CP-751,871