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Study With AG-013736 Combined With Chemotherapy And Bevacizumab In Patients With Metastatic Colorectal Cancer

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Daphne, Alabama, 36526 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Colorectal 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

- (Phase 1) Patients with any solid/GI tumor who have had no more than 1 previous
chemotherapy for greater than 3 months prior to enrollment

- (Phase 2) Patients with locally advanced or metastatic colorectal cancer (CRC)
previously untreated with any systemic therapy.

- Patients treated with adjuvant chemotherapy (with radiation) will be eligible if last
treatment was > 12 months prior to enrollment,

- Patients must have measurable disease by RECIST and if any history of hypertension, it
must be controlled with medication.

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

- Prior system therapy for advanced CRC (Ph 2 portion only)

- Prior treatment with anti-angiogenesis agent such as bevacizumab or VEGF inhibitors.

- Prior irradiation of greater than 25% of bone marrow (whole pelvis = 25%)

- Prior radiation, major surgery, or investigational agent within 4 weeks of study entry
except palliative radiotherapy to non-target, metastatic lesions. Minor surgeries
should be completed > 2 weeks of enrollment and be fully recovered from any procedure.

NCT00460603
Pfizer
Completed
Study With AG-013736 Combined With Chemotherapy And Bevacizumab In Patients With Metastatic Colorectal Cancer

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Study With AG-013736 Combined With Chemotherapy And Bevacizumab In Patients With Metastatic Colorectal Cancer
A Randomized Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Combinations With Chemotherapy And Bevacizumab In Patients With Metastatic Colorectal Cancer Preceded By A Phase 1 Portion
To determine the safety and efficacy of AG-013736 in combination with other standard of care medication in patients with first line metastatic colorectal cancer.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Colorectal Neoplasms
  • Drug: bevacizumab
    bevacizumab 5 mg/kg every 2 weeks
  • Drug: AG-013726
    AG-013726 5 mg bid every 2 weeks
  • Drug: AG-013736 (axitinib)
    AG-013736 5 mg bid starting dose
  • Active Comparator: B
    bevacizumab 5 mg/kg every 2 weeks + FOLFOX
    Intervention: Drug: bevacizumab
  • Experimental: C
    AG-013726 5 mg bid+ bevacizumab 2 mg/kg every 2 weeks + FOLFOX
    Intervention: Drug: AG-013726
  • Experimental: A
    AG-013736 5 mg bid starting dose + FOLFOX
    Intervention: Drug: AG-013736 (axitinib)
Hoh CK, Burris HA 3rd, Bendell JC, Tarazi J, Rosbrook B, Kim S, Infante JR, Reid TR. Intermittent dosing of axitinib combined with chemotherapy is supported by (18)FLT-PET in gastrointestinal tumours. Br J Cancer. 2014 Feb 18;110(4):875-81. doi: 10.1038/bjc.2013.806. Epub 2014 Jan 14.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
187
November 2012
April 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • (Phase 1) Patients with any solid/GI tumor who have had no more than 1 previous chemotherapy for greater than 3 months prior to enrollment
  • (Phase 2) Patients with locally advanced or metastatic colorectal cancer (CRC) previously untreated with any systemic therapy.
  • Patients treated with adjuvant chemotherapy (with radiation) will be eligible if last treatment was > 12 months prior to enrollment,
  • Patients must have measurable disease by RECIST and if any history of hypertension, it must be controlled with medication.

Exclusion Criteria:

  • Prior system therapy for advanced CRC (Ph 2 portion only)
  • Prior treatment with anti-angiogenesis agent such as bevacizumab or VEGF inhibitors.
  • Prior irradiation of greater than 25% of bone marrow (whole pelvis = 25%)
  • Prior radiation, major surgery, or investigational agent within 4 weeks of study entry except palliative radiotherapy to non-target, metastatic lesions. Minor surgeries should be completed > 2 weeks of enrollment and be fully recovered from any procedure.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00460603
A4061020
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2013

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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