CP-868,596 And CP-868,596 Plus AG-013736 In Combination With Docetaxel In Advanced Solid Tumors

Arog Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: CP-868,596; Drug: AG-013736; Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00949624

A5301005

Details and patient eligibility

About

A5301005 is a phase 1 study in patients with solid tumors which is testing the safety and tolerability of adding targeted agents to a standard chemotherapy. CP-868,596 is a platelet-derived growth factor receptor inhibitor (PDGFR) and AG-13736 is a vascular endothelial growth factor receptor inhibitor (VEGFR). This study will test the use of docetaxel (the standard chemotherapy) with either CP-868,596 or the combination of CP-868,596 and AG-13736.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be ≥18 years old and with histologically or cytologically confirmed advanced solid tumors refractory/resistant to currently available therapies or for which there is no standard therapy.
• Patients with primary brain tumors are not eligible.
• Have at least one site of measurable disease.

Exclusion criteria

• Received chemotherapy (including targeted agents such as erlotinib), radiotherapy, immunotherapy or any investigational therapy within 3 weeks of study entry (within 6 weeks for previous treatments with nitrosoureas or mitomycin C).
• Received tamoxifen within 4 weeks prior to study entry.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 4 patient groups

Cohort 1

Experimental group

Description:

60 mg BID/ 75 mg/m2

Treatment:

Drug: CP-868,596

Drug: Docetaxel

Drug: CP-868,596

Drug: Docetaxel

Drug: CP-868,596

Drug: Docetaxel

Drug: CP-868,596

Drug: Docetaxel

Cohort 2

Experimental group

Description:

100 mg BID/75 mg/m2

Treatment:

Drug: CP-868,596

Drug: Docetaxel

Drug: CP-868,596

Drug: Docetaxel

Drug: CP-868,596

Drug: Docetaxel

Drug: CP-868,596

Drug: Docetaxel

Cohort 3

Experimental group

Description:

100 mg BID/100 mg/m2

Treatment:

Drug: CP-868,596

Drug: Docetaxel

Drug: CP-868,596

Drug: Docetaxel

Drug: CP-868,596

Drug: Docetaxel

Drug: CP-868,596

Drug: Docetaxel

Cohort 4b

Experimental group

Description:

CP-868,596 + AG-013736 + TXT 75

Treatment:

Drug: CP-868,596

Drug: Docetaxel

Drug: CP-868,596

Drug: Docetaxel

Drug: CP-868,596

Drug: Docetaxel

Drug: CP-868,596

Drug: Docetaxel

Drug: AG-013736