Trial Of PF-00299804 In Patients With Advanced Refractory Lung Cancer

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00553254

First received: November 2, 2007

Last updated: May 7, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 2, 2007

Last Updated Date

May 7, 2013

Start Date ^ICMJE

February 2008

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Endpoints- Phase 1- Recommended phase 2 dose. [ Time Frame: 30-AUG-2008 ] [ Designated as safety issue: Yes ]
Phase 2- Progression -free survival at 4 months [ Time Frame: 26-JUL-2010 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Endpoints- Phase 1- Recommended phase 2 dose.
Phase 2- Overall response according to Response Evaluation Criteria in Solid Tumors.

Change History

Complete list of historical versions of study NCT00553254 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Overall response according to Response Evaluation Criteria in Solid Tumors. [ Time Frame: 30-JAN-2010 ] [ Designated as safety issue: No ]
Overall survival at 6 months [ Time Frame: 26-JUL-2010 ] [ Designated as safety issue: No ]
Safety profile as characterized by type, frequency, severity [as graded by NCI CTCAE v.3.0], timing and relationship to study treatment of adverse events and laboratory abnormalities observed. [ Time Frame: 26-JUL-2010 ] [ Designated as safety issue: Yes ]
Phase 1- Single and multiple dose pharmacokinetic parameters of PF_00299804 [ Time Frame: 30-MAR-2009 ] [ Designated as safety issue: No ]
Phase 2-Duration of overall response [ Time Frame: 26-JUL-2010 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Phase 1-
1. Single and multiple dose pharmacokinetic parameters of PF_00299804
Phase 2-
1. Duration of overall response
2. Progression -free survival at 6 months
3. Overall survival at 6 months
4. Safety profile as characterized by type, frequency, severity [as graded by NCI CTCAE v.3.0], timing and relationship to study treatment of adverse events and laboratory abnormalities observed.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Trial Of PF-00299804 In Patients With Advanced Refractory Lung Cancer

Official Title ^ICMJE

A Phase 1/2, Open Label, Single Arm Trial To Determine The Recommended Phase 2 Dose And Evaluate The Efficacy Of Pf 00299804 In Patients In Korea With Kras Wild Type Advanced NSCLC, Which Is Refractory To Chemotherapy And Erlotinib Or Gefitinib

Brief Summary

To assess the safety and efficacy of PF-00299804 in patients with advanced lung cancer.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Carcinoma, Non Small Cell Lung

Intervention ^ICMJE

Drug: PF-00299804

Single arm (no comparator) study, oral once daily dosing, dose escalation (it is a phase 1/2 study) until disease progression, unacceptable toxicity or withdrawal of consent

Study Arm (s)

Experimental: 1

Intervention: Drug: PF-00299804

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

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

December 2013

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Advanced NSCLC
Prior treatment with and failure of at least one regimen of chemotherapy and erlotinib or gefitinib
Prior treatment with no more than two chemotherapy regimens, including adjuvant treatment
Measurable disease

Exclusion Criteria:

Chemotherapy, radiotherapy, biological or investigational agents within 4 weeks of baseline disease assessment
Patients who lack of tolerance of erlotinib therapy
Patients with known brain Metastases
Patients with demonstrated history of or presence of interstitial lung disease.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00553254

Other Study ID Numbers ^ICMJE

A7471003

Has Data Monitoring Committee

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

May 2013

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

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