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Picoplatin as Second-Line Therapy for Patients With Small Cell Lung Cancer

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: NCT00116610
Recruitment Status : Completed
First Posted : June 30, 2005
Last Update Posted : January 21, 2009
Sponsor:
Information provided by:
Poniard Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE June 29, 2005
First Posted Date  ICMJE June 30, 2005
Last Update Posted Date January 21, 2009
Study Start Date  ICMJE June 2005
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2005)
Efficacy and safety (outcomes will be measured approximately 1 year after the last subject has been treated)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00116610 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Picoplatin as Second-Line Therapy for Patients With Small Cell Lung Cancer
Official Title  ICMJE A Phase II Study of Picoplatin as Second-Line Therapy for Subjects With Resistant or Refractory Small Cell Lung Cancer
Brief Summary This is a Phase II research study that is designed for patients who have small cell lung cancer (SCLC) that is no longer responding to treatment. Patients will receive picoplatin, a new platinum-based agent that is currently under investigation, in 21-day cycles.
Detailed Description Platinum drugs work by binding to DNA and preventing the rapid cell division of tumors. However, many tumors demonstrate a resistance to platinum drugs. Results from preclinical studies indicate that picoplatin (previously called AMD473 or ZD0473) may be able to overcome or partially overcome platinum resistance. More than 500 patients have received picoplatin in previous Phase I or Phase II clinical trials.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Small Cell Lung Cancer
Intervention  ICMJE Drug: picoplatin
Study Arms  ICMJE Not Provided
Publications *

*   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
Enrollment  ICMJE
 (submitted: June 29, 2005)
75
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Main inclusion criteria:

  1. Diagnosis of small cell lung cancer.
  2. Patients must have had one prior chemotherapy regimen which must have included either cisplatin or carboplatin.

[Additional eligibility criteria apply.]

Exclusion Criteria:

  • Prior radiotherapy that included > 30% of the bone marrow (i.e., the whole of the pelvis or half of the spine).
  • Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom.
  • Significant heart disease.
  • Uncontrolled, untreated, unstable, or symptomatic brain tumors or central nervous system disease.
  • Grade 2+ peripheral neuropathy (a condition caused by damage to the nerves in the peripheral nervous system).

[Additional exclusion criteria apply.]

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,   Russian Federation,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00116610
Other Study ID Numbers  ICMJE 0402
IND No. 69,507
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Poniard Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hazel Breitz, MD Poniard Pharmaceuticals
Study Director: Paul Weiden, MD Poniard Pharmaceuticals
Study Director: David Karlin, MD Poniard Pharmaceuticals
PRS Account Poniard Pharmaceuticals
Verification Date February 2007

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