MEK Inhibitor PD-325901 To Treat Advanced Non-Small Cell Lung Cancer
This study has been terminated.
(Terminated [See Detailed Description for Termination Reason.])
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00174369
First received: September 9, 2005
Last updated: March 16, 2009
Last verified: February 2009
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Purpose
MEK is a critical member of the MAPK pathway involved in growth and survival of cancer cells. PD-325901 is a new drug designed to block this pathway and kill cancer cells. The purpose of this study is to study the effectiveness of PD-325901 in patients with non-small cell lung cancer. PD-325901 will be given by mouth as a pill twice a day, CT scans will be done and biopsies of a tumor and a blood sample will be taken before treatment to examine the how genes affect tumor response to the study medication. Blood samples will be taken to measure the amount of drug in the blood.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Non-Small-Cell Lung |
Drug: PD-0325901 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 2 Study Of The MEK Inhibitor PD-0325901 In Patients With Advanced Non-Small Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- To determine the activity of PD-0325901 in advanced non-small cell lung cancer [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To determine the progression-free survival [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]
- To determine the duration of response [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]
- To determine the overall survival [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]
- To determine the safety profile of PD-0325901 [ Time Frame: Duration of trial ] [ Designated as safety issue: Yes ]
- To explore pharmacogenomic and cancer biomarkers (gene and/or protein expression profiling) relationships with cancer- and treatment-related outcomes duration of response [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]
- To evaluate PD-0325901 population pharmacokinetics and explore its correlation with efficacy and safety parameters [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]
- To explore pharmacogenomic and cancer biomarkers (gene and/or protein expression profiling) relationships with cancer- and treatment-related outcomes [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]
| Enrollment: | 34 |
| Study Start Date: | November 2005 |
| Study Completion Date: | June 2007 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PD0325901
15 mg BID
|
Drug: PD-0325901
15 mg BID
|
Detailed Description:
This study was terminated prematurely on 23 March 2007 due to safety issues (ocular and neurological toxicity observed in another PD-0325901 study, A4581001) as well as lack of objective responses
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically documented non-small cell lung cancer with metastases (Stage IV or recurrent disease) or locally advanced (Stage IIIB) with malignant pleural effusion with no expectation of further effects of prior anticancer therapy, and resolution of all acute toxic effects
- Adequate renal, liver, and bone marrow function, determined within 2 weeks prior to the first treatment and an ECOG status of <=1.
- Must have evidence of progression of disease within 6 months of most recent prior systemic anticancer therapy.
Exclusion Criteria:
- No parathyroid disorder or history of malignancy associated hypercalcemia
- No ongoing radiation therapy or radio-cytotoxic therapy within prior 4 weeks; No immunotherapy, biologic therapy, hormonal, or molecular targeted therapy within prior 2 weeks
- No concurrent serious infection or life-threatening illness (unrelated to tumor)
- No history of a malignancy (other tha non-small cell lung cancer) except those treated with curative intent for skin cancer (other than melanoma) or in situ breast or cervical cancer or those treated with curative intent for any other cancer with no evidence of disease for 5 years.
- No active seizure disorders or untreated brain metastases.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00174369
Locations
| United States, California | |
| Pfizer Investigational Site | |
| Greenbrae, California, United States, 94904 | |
| Pfizer Investigational Site | |
| La Jolla, California, United States, 92093 | |
| Pfizer Investigational Site | |
| LaJolla, California, United States, 92037 | |
| Pfizer Investigational Site | |
| San Diego, California, United States, 92103 | |
| Pfizer Investigational Site | |
| San Mateo, California, United States, 94402 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Tampa, Florida, United States, 33612 | |
| United States, Michigan | |
| Pfizer Investigational Site | |
| Ann Arbor, Michigan, United States, 48106-0995 | |
| Pfizer Investigational Site | |
| Detroit, Michigan, United States, 48201 | |
| Pfizer Investigational Site | |
| Farmington Hills, Michigan, United States, 48334 | |
| United States, Minnesota | |
| Pfizer Investigational Site | |
| Coon Rapids, Minnesota, United States, 55433 | |
| Pfizer Investigational Site | |
| Fridley, Minnesota, United States, 55432 | |
| Pfizer Investigational Site | |
| Robbinsdale, Minnesota, United States, 55422 | |
| United States, New York | |
| Pfizer Investigational Site | |
| New York, New York, United States, 11725 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19111 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00174369 History of Changes |
| Other Study ID Numbers: | A4581002 |
| Study First Received: | September 9, 2005 |
| Last Updated: | March 16, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic |
Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013