Investigational Agent AG-013736 In Combinations With Standard Of Care Treatments For Patient's With Advanced Solid Tumor

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NCT00454649

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Study Location
Pfizer Investigational Site
Augusta, Georgia, 30909, United States
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1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Advanced solid tumors suitable for treatment with Taxanes, with or without carboplatin, or treatment with Capecitabine, Gemcitabine/Cisplatin. or Pemetrexed/Cisplatin

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Tumors abutting or providing support for blood vessels


- Any significant gastrointestinal abnormalities or active bleeding.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Investigational Agent AG-013736 In Combinations With Standard Of Care Treatments For Patient's With Advanced Solid Tumor
Official Title  ICMJE A Phase 1 Dose-Finding Study Of The Anti-Angiogenesis Agent, AG-013736, In Combinations Of Paclitaxel/Carboplatin, Weekly Paclitaxel, Docetaxel, Capecitabine, Gemcitabine/Cisplatin and Pemetrexed/Cisplatin In Patients With Advanced Solid Tumors
Brief Summary To determine the best dose of this investigational agent AG-013736 in combination with various standard of care treatments for advanced solid tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasms
Intervention  ICMJE
  • Drug: Axitinib + Paclitaxel + Carboplatin (Cohort 1)
    Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
  • Drug: Axitinib + Paclitaxel + Carboplatin (Cohort 2)
    Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
  • Drug: Axitinib + Paclitaxel + Carboplatin (Cohort 3)
    Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
  • Drug: Axitinib + Paclitaxel (Cohort 4)
    Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
  • Drug: Axitinib + Docetaxel + Carboplatin (Cohort 4a)
    Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Docetaxel (75 mg/m^2) 60-minute infusion on Day 1 of every cycle. Carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
  • Drug: Axitinib + Docetaxel (Cohort 5)
    Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
  • Drug: Axitinib + Capecitabine (Cohort 6)
    Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
  • Drug: Axitinib + Capecitabine (Cohort 7)
    Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
  • Drug: Axitinib + Gemcitabine + Cisplatin (Cohort 8)
    Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
  • Drug: Axitinib + Pemetrexed + Cisplatin (Cohort 9)
    Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
Study Arms  ICMJE Experimental: Axitinib [AG-013736] + chemotherapy combination

The following separate groups were included:

axitinib

  1. plus carboplatin/paclitaxel in three different schedules
  2. plus paclitaxel
  3. plus docetaxel/carboplatin
  4. plus docetaxel
  5. plus capecitabine
  6. plus gemcitabine/cisplatin
  7. plus pemetrexed/cisplatin
Interventions:
  • Drug: Axitinib + Paclitaxel + Carboplatin (Cohort 1)
  • Drug: Axitinib + Paclitaxel + Carboplatin (Cohort 2)
  • Drug: Axitinib + Paclitaxel + Carboplatin (Cohort 3)
  • Drug: Axitinib + Paclitaxel (Cohort 4)
  • Drug: Axitinib + Docetaxel + Carboplatin (Cohort 4a)
  • Drug: Axitinib + Docetaxel (Cohort 5)
  • Drug: Axitinib + Capecitabine (Cohort 6)
  • Drug: Axitinib + Capecitabine (Cohort 7)
  • Drug: Axitinib + Gemcitabine + Cisplatin (Cohort 8)
  • Drug: Axitinib + Pemetrexed + Cisplatin (Cohort 9)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 29, 2011)		102
Original Enrollment  ICMJE
 (submitted: March 30, 2007)		62
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Advanced solid tumors suitable for treatment with Taxanes, with or without carboplatin, or treatment with Capecitabine, Gemcitabine/Cisplatin. or Pemetrexed/Cisplatin

Exclusion Criteria:

  • Tumors abutting or providing support for blood vessels
  • Any significant gastrointestinal abnormalities or active bleeding.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00454649
Other Study ID Numbers  ICMJE A4061019
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP