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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Augusta, Georgia, 30909 United States
Contact
1-800-718-1021
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.

NCT00454649
Pfizer
Completed
Investigational Agent AG-013736 In Combinations With Standard Of Care Treatments For Patient's With Advanced Solid Tumor

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Investigational Agent AG-013736 In Combinations With Standard Of Care Treatments For Patient's With Advanced Solid Tumor
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
To determine the best dose of this investigational agent AG-013736 in combination with various standard of care treatments for advanced solid tumors.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Neoplasms
  • 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.
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)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
April 2011
August 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Poland,   Spain,   United States
 
 
NCT00454649
A4061019
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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