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Completed

NCT Number: NCT00949624

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

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.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, East Melbourne, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CP-868,596

Drug

Oral tablet 60 mg BID continuous

docetaxel

Drug

Intravenous 75 mg/m2 every three weeks

AG-013736

Drug

Oral tablet 5 mg BID continuous

Primary outcomes

  1. First-cycle Dose Limiting Toxicities

    Time frame: 2.5 years

Secondary outcomes

  1. 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

  2. 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

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

    Time frame: 2.5 years

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

    Time frame: 2.5 years

  5. 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

  6. 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

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

    Time frame: 2.5 years

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

    Time frame: 2.5 years

Sponsors and collaborators

Lead sponsor

Arog Pharmaceuticals, Inc.

Industry

Registry information

Official study title

Phase I Study To Determine The Maximally Tolerated Dose Of Oral, Daily CP-868,596 And CP-868,596 Plus AG-013736 When Given In Combination With Docetaxel Administered Every 3 Weeks To Patients With Advanced Solid Tumors

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jul 30, 2009
Registry last updated
Jan 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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