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

NCT ID: NCT00949624

Last Updated: 2012-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Solid Tumors

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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Cohort 1

60 mg BID/ 75 mg/m2

Group Type EXPERIMENTAL

CP-868,596

Intervention Type DRUG

Oral tablet 60 mg BID continuous

Docetaxel

Intervention Type DRUG

Intravenous 75 mg/m2 every three weeks

Cohort 2

100 mg BID/75 mg/m2

Group Type EXPERIMENTAL

CP-868,596

Intervention Type DRUG

Oral tablet 100 mg BID continuous

Docetaxel

Intervention Type DRUG

Intravenous 75 mg/m2 every three weeks

Cohort 3

100 mg BID/100 mg/m2

Group Type EXPERIMENTAL

CP-868,596

Intervention Type DRUG

Oral tablet 100 mg BID continuous

Docetaxel

Intervention Type DRUG

Intravenous 100 mg/m2 every three weeks

Cohort 4b

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

Group Type EXPERIMENTAL

CP-868,596

Intervention Type DRUG

Oral tablet 60 mg BID continuous

AG-013736

Intervention Type DRUG

Oral tablet 5 mg BID continuous

Docetaxel

Intervention Type DRUG

Intravenous 75 mg/m2 every three weeks

Interventions

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CP-868,596

Oral tablet 60 mg BID continuous

Intervention Type DRUG

Docetaxel

Intravenous 75 mg/m2 every three weeks

Intervention Type DRUG

CP-868,596

Oral tablet 100 mg BID continuous

Intervention Type DRUG

Docetaxel

Intravenous 75 mg/m2 every three weeks

Intervention Type DRUG

CP-868,596

Oral tablet 100 mg BID continuous

Intervention Type DRUG

Docetaxel

Intravenous 100 mg/m2 every three weeks

Intervention Type DRUG

CP-868,596

Oral tablet 60 mg BID continuous

Intervention Type DRUG

AG-013736

Oral tablet 5 mg BID continuous

Intervention Type DRUG

Docetaxel

Intravenous 75 mg/m2 every three weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arog Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Durham, North Carolina, United States

Site Status

Pfizer Investigational Site

East Melbourne, Victoria, Australia

Site Status

Countries

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United States Australia

Related Links

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Other Identifiers

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A5301005

Identifier Type: -

Identifier Source: org_study_id

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