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Trial record 1 of 1 for:    NCT00982267
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A Trial Of SU14813 In Patients With Advanced Solid Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00982267
Recruitment Status : Completed
First Posted : September 23, 2009
Last Update Posted : August 8, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 22, 2009
First Posted Date  ICMJE September 23, 2009
Last Update Posted Date August 8, 2011
Study Start Date  ICMJE December 2003
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2009)
Maximum Tolerated Dose (MTD) [ Time Frame: 18-Nov-2008 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2009)
  • Determine the recommended Phase 2 dose (RP2D) [ Time Frame: 18-Nov-2008 ]
  • Preliminary information on SU014813 anti-tumor effect; [ Time Frame: 18-Nov-2008 ]
  • Plasma pharmacokinetics [ Time Frame: 18-Nov-2008 ]
  • Plasma targets such as vascular endothelial growth factor (VEGF), soluble VEGF-R2 and soluble KITa [ Time Frame: 18-Nov-2008 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial Of SU14813 In Patients With Advanced Solid Malignancies
Official Title  ICMJE A Phase I Dose Escalating Study Of SU014813 In Patients With Solid Tumors Not Amenable To Conventional Therapy
Brief Summary The purpose of this study is to define the Maximum tolerated dose of SU14813 when administered as single agent in patients with solid tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Neoplasms
  • Solid Tumors
Intervention  ICMJE Drug: SU014813
Escalating doses of SU014813 from 50 to 250mg/day . Capsules administered daily either as continuous dosing or in cycles of 4 weeks on 1 week off
Study Arms  ICMJE Experimental: SU014813
Intervention: Drug: SU014813
Publications * Fiedler W, Giaccone G, Lasch P, van der Horst I, Brega N, Courtney R, Abbattista A, Shalinsky DR, Bokemeyer C, Boven E. Phase I trial of SU14813 in patients with advanced solid malignancies. Ann Oncol. 2011 Jan;22(1):195-201. doi: 10.1093/annonc/mdq313. Epub 2010 Jul 6.

*   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: September 22, 2009)
77
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with a histologically proven advanced solid malignancy for which no recognized therapy was available or for which standard therapy had failed
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Serum albumin ≥3.0 g/dL and adequate haemopoietic, renal and liver function

Exclusion Criteria:

  • Chemotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) or radiotherapy or an investigational agent within 4 weeks before the start of study treatment
  • Subjects had to have recovered from all prior treatment toxicities, except alopecia, and from any major surgery.
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 Germany,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00982267
Other Study ID Numbers  ICMJE RTKD-7840-002
A6191002
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 August 2011

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