Trial record 1 of 1 for:
NCT00321308
Trial of Pemetrexed With or Without PF-3512676 in Advanced Non-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: NCT00321308 |
Recruitment Status :
Terminated
(See Termination Reason in Detailed Description.)
First Posted : May 3, 2006
Last Update Posted : September 28, 2009
|
Sponsor:
Pfizer
Information provided by:
Pfizer
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | May 2, 2006 | |||
First Posted Date ICMJE | May 3, 2006 | |||
Last Update Posted Date | September 28, 2009 | |||
Study Start Date ICMJE | September 2006 | |||
Actual Primary Completion Date | January 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Progression-free survival [ Time Frame: 110 Events ] | |||
Original Primary Outcome Measures ICMJE |
Progression-free survival | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE |
Time to Tumor Progression Overall Objective Response Rate Duration of Response Overall Survival Overall Safety Profile Patient Reported Outcome Pharmacokinetic Parameters | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Trial of Pemetrexed With or Without PF-3512676 in Advanced Non-Small Cell Lung Cancer | |||
Official Title ICMJE | A Randomized Phase II Trial Of Pemetrexed With Or Without PF-3512676 For The Treatment Of Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer After Failure Of One Prior Chemotherapy Regimen For Advanced Disease | |||
Brief Summary | To assess the efficacy and safety of PF-3512676 administered in combination with pemetrexed for the treatment of patients with locally advanced or metastatic NSCLC who have failed one prior chemotherapy regimen | |||
Detailed Description | PF-3512676 dosing was stopped 21 June 2007 when Pfizer decided to stop the administration of PF-3512676 in all trials which combined PF-3512676 with cytotoxic chemotherapy. The decision was made subsequent to DSMC recommendation to close two phase III randomized trials in non-small cell lung cancer which also combined PF-3512676 with cytotoxic chemotherapy, citing lack of efficacy concerns as the primary reason with safety issues (sepsis, thrombocytopenia) also contributing to the decision. Subjects were allowed to complete standard of care treatment and protocol follow-up. Data collection was completed on 31 January 2008. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||
Condition ICMJE | Carcinoma, Non-Small Cell Lung | |||
Intervention ICMJE |
|
|||
Study Arms ICMJE |
|
|||
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 | Terminated | |||
Actual Enrollment ICMJE |
36 | |||
Original Enrollment ICMJE |
130 | |||
Actual Study Completion Date ICMJE | January 2008 | |||
Actual Primary Completion Date | January 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender ICMJE |
|
|||
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, Italy, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00321308 | |||
Other Study ID Numbers ICMJE | A8501004 | |||
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 |
|
|||
PRS Account | Pfizer | |||
Verification Date | September 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |