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A Study Of AG-013736 (Axitinib) Or Bevacizumab (Avastin) In Combination With Paclitaxel And Carboplatin In Patients With Advanced Lung Cancer.

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Baton Rouge, Louisiana, 70809 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Small-Cell Lung Carcinoma, Adenocarcinoma
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 non squamous cell, lung cancer

- No prior treatment for lung cancer except prior adjuvant therapy if last dose was >12
months prior to enrollment

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

- Prior therapy for advanced lung cancer

- The need for blood-thinners

- Coughing up blood

NCT00600821
Pfizer
Completed
A Study Of AG-013736 (Axitinib) Or Bevacizumab (Avastin) In Combination With Paclitaxel And Carboplatin In Patients With Advanced Lung Cancer.

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A Study Of AG-013736 (Axitinib) Or Bevacizumab (Avastin) In Combination With Paclitaxel And Carboplatin In Patients With Advanced Lung Cancer.
Randomized Phase 2 Trial Of AG013736 Or Bevacizumab In Combination With Paclitaxel And Carboplatin As First Line Treatment For Patients With Advanced Non Small Cell Lung Cancer
To determine if the addition of AG-013736 to chemotherapy is beneficial in patients with advanced lung cancer who have not been previously treated.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Non-Small-Cell Lung Carcinoma
  • Adenocarcinoma
  • Drug: Bevacizumab
    Bevacizumab is available as 100 and 400 mg preservative-free, single use vials- The starting dose is 15 mg/kg, iv infusion, every 3 weeks.
    Other Name: Avastin
  • Drug: Carboplatin
    Carboplatin is available as pre-mixed 10mg /ml aqueous solution- The starting dose is AUC 6 mg*min/ml, iv infusion, every 3 weeks.
  • Drug: Paclitaxel
    Paclitaxel is available in multidose vials (30 mg/5ml;100mg/16.7 ml;300 mg/50ml)- The starting dose is 200 mg/m2, every 3 weeks
  • Drug: AG-013736 (axitinib)
    AG-013736 (axitinib) is available as 1mg, and 5 mg film-coated tablets for oral administration- The starting dose is 5 mg BID-
    Other Name: axitinib Taxol
  • Active Comparator: B
    Bevacizumab will be administered in combination with carboplatin and paclitaxel.
    Interventions:
    • Drug: Bevacizumab
    • Drug: Carboplatin
    • Drug: Paclitaxel
  • Experimental: A
    AG-013736 will be administered in combination with carboplatin and paclitaxel.
    Interventions:
    • Drug: AG-013736 (axitinib)
    • Drug: Carboplatin
    • Drug: Paclitaxel
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
118
October 2012
April 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Advanced non squamous cell, lung cancer
  • No prior treatment for lung cancer except prior adjuvant therapy if last dose was >12 months prior to enrollment

Exclusion Criteria:

  • Prior therapy for advanced lung cancer
  • The need for blood-thinners
  • Coughing up blood
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   France,   Poland,   Spain,   United Kingdom,   United States
 
 
NCT00600821
A4061030
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 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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1-800-718-1021

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