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

Arog Pharmaceuticals, Inc.50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumors

Interventions

CP-868,596DRUG

Oral tablet 60 mg BID continuous

DocetaxelDRUG

Intravenous 75 mg/m2 every three weeks

CP-868,596DRUG

Oral tablet 100 mg BID continuous

Docetaxel

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Pfizer Investigational Site

Durham, North Carolina, United States

Pfizer Investigational Site

East Melbourne, Victoria, Australia

Outcomes

Primary Outcomes

First-cycle Dose Limiting Toxicities

Time frame: 2.5 years

Secondary Outcomes

Determine the safety and tolerability of the combination of daily CP-868,596 and docetaxel on an every 3-week schedule

Time frame: 2.5 years

Determine the safety and tolerability of the combination of daily CP-868,596 plus daily AG-013736 plus docetaxel on an every 3-week schedule

Time frame: 2.5 years

To evaluate the pharmacokinetics (PK) of CP-868,596 and docetaxel when given in combination

Time frame: 2.5 years

To evaluate the pharmacokinetics (PK) of CP-868,596, AG-013736 and docetaxel when given in combination

Time frame: 2.5 years

Conduct biomarker investigations on plasma/serum samples to explore critical events in pharmacodynamic response to CP-868,596 (eg, VEGF, phospho-SHP, etc.)

Time frame: 2.5 years

To explore the relationship between polymorphisms in genes involved in the metabolism and transport of CP-868,596 and pharmacokinetic/pharmacodynamic parameters

Time frame: 2.5 years

To explore the effects of CP-868,596 on tumor blood flow and permeability via DCE-MRI

Time frame: 2.5 years

To assess any preliminary clinical evidence of anti-tumor activity using RECIST

Time frame: 2.5 years

Data from ClinicalTrials.gov

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