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Trial record 1 of 1 for:    NCT00528619
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A Study To Find The Best Dose Of SU011248 When Given With Pemetrexed, Pemetrexed And Cisplatin Or Pemetrexed And Carboplatin In Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT00528619
Recruitment Status : Completed
First Posted : September 12, 2007
Last Update Posted : April 8, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 10, 2007
First Posted Date  ICMJE September 12, 2007
Last Update Posted Date April 8, 2011
Study Start Date  ICMJE November 2006
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
To determine maximally tolerated dose of SU011248 (dosed continuously or on a 2/1 Schedule) when given in combination with pemetrexed, pemetrexed and cisplatin or pemetrexed and carboplatin. [ Time Frame: From screening until at least 28 days beyond discontinuation of study treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 10, 2007)
To determine maximally tolerated dose of SU011248 (dosed continuously or on a 2/1 Schedule) when given in combination with pemetrexed, pemetrexed and cisplatin or pemetrexed and carboplatin.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2008)
  • To evaluate the plasma pharmacokinetics of SU011248 and its metabolite, SU012662 in addition to pemetrexed, SU011248 and pemetrexed/cisplatin, and SU011248 and pemetrexed/carboplatin when these drugs are co-administered. [ Time Frame: From screening until disease progression or discontinuation of the study ]
  • To preliminarily assess the antitumor activity of SU011248 in addition to pemetrexed, SU011248 and pemetrexed/cisplatin, and SU011248 and pemetrexed/carboplatin in patients with non-small cell lung cancer or advanced unresectable mesothelioma. [ Time Frame: From screening until disease progression or discontinuation of the study ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2007)
  • To evaluate the pharmacokinetics of SU011248 and pemetrexed, SU011248, pemetrexed and cisplatin and SU011248, pemetrexed and carboplatin when these drugs are co-administered.
  • To preliminarily assess the antitumor activity of SU011248 and pemetrexed in non-small cell lung cancer patients.
  • To preliminarily assess the antitumor activity of SU011248, pemetrexed and cisplatin and SU011248, pemetrexed and carboplatin in patients with non-small cell lung cancer or advanced unresectable mesothelioma.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Find The Best Dose Of SU011248 When Given With Pemetrexed, Pemetrexed And Cisplatin Or Pemetrexed And Carboplatin In Patients With Advanced Solid Tumors
Official Title  ICMJE Phase I Study Of SU011248 In Combination With Pemetrexed, Pemetrexed/Cisplatin And Pemetrexed/Carboplatin In Patients With Advanced Solid Malignancies
Brief Summary This study will assess the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with pemetrexed, pemetrexed and cisplatin or pemetrexed and carboplatin in patients with 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: Sunitinib, Pemetrexed, Cisplatin, Carboplatin
Dose finding study using Sunitinib daily by oral capsule in a continuous regimen or administered for 2 weeks out of every 3 weeks, with pemetrexed every 3 weeks or also with cisplatin 75 mg/m2 or carboplatin AUC=5 mg*min/mL until progression or unacceptable toxicity.
Other Name: Sutent, SU011248, Alimta, Platinol, Paraplatin
Study Arms  ICMJE Experimental: A
Intervention: Drug: Sunitinib, Pemetrexed, Cisplatin, Carboplatin
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 16, 2010)
96
Original Enrollment  ICMJE
 (submitted: September 10, 2007)
100
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with a diagnosis of a solid cancer which is not responsive to standard therapy or for which no standard therapy exists.
  • Patient has a good performance status (ECOG 0 or 1).

Exclusion Criteria:

  • Prior treatment with either pemetrexed or SU011248.
  • Coughing up blood within 4 weeks before starting study treatment (small amounts okay).
  • Hypertension that cannot be controlled by medications.
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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00528619
Other Study ID Numbers  ICMJE A6181084
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2011

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