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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arog Pharmaceuticals LLC
ClinicalTrials.gov Identifier:
NCT00949624
First received: July 24, 2009
Last updated: January 18, 2012
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Advanced Solid Tumors
Drug: CP-868,596
Drug: Docetaxel
Drug: AG-013736
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Arog Pharmaceuticals LLC:

Primary Outcome Measures:
  • First-cycle Dose Limiting Toxicities [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • To evaluate the pharmacokinetics (PK) of CP‑868,596 and docetaxel when given in combination [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
  • To evaluate the pharmacokinetics (PK) of CP‑868,596, AG‑013736 and docetaxel when given in combination [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To explore the effects of CP‑868,596 on tumor blood flow and permeability via DCE‑MRI [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • To assess any preliminary clinical evidence of anti‑tumor activity using RECIST [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: December 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
60 mg BID/ 75 mg/m2
Drug: CP-868,596
Oral tablet 60 mg BID continuous
Drug: Docetaxel
Intravenous 75 mg/m2 every three weeks
Experimental: Cohort 2
100 mg BID/75 mg/m2
Drug: CP-868,596
Oral tablet 100 mg BID continuous
Drug: Docetaxel
Intravenous 75 mg/m2 every three weeks
Experimental: Cohort 3
100 mg BID/100 mg/m2
Drug: CP-868,596
Oral tablet 100 mg BID continuous
Drug: Docetaxel
Intravenous 100 mg/m2 every three weeks
Experimental: Cohort 4b
CP-868,596 + AG-013736 + TXT 75
Drug: CP-868,596
Oral tablet 60 mg BID continuous
Drug: AG-013736
Oral tablet 5 mg BID continuous
Drug: Docetaxel
Intravenous 75 mg/m2 every three weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00949624

Locations
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27710
Australia, Victoria
Pfizer Investigational Site
East Melbourne, Victoria, Australia, 3002
Sponsors and Collaborators
Arog Pharmaceuticals LLC
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Arog Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT00949624     History of Changes
Other Study ID Numbers: A5301005
Study First Received: July 24, 2009
Last Updated: January 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Arog Pharmaceuticals LLC:
PDGFr Inhibition;
VEGFr inhibition;
targeted therapy

Additional relevant MeSH terms:
Neoplasms
Axitinib
Crenolanib
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014