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-02341066 and PF-00299804 for Advanced Non-Small Cell Lung Cancer

NCT01441128 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-12-17

No results posted yet for this study

Summary

Background:

\- PF-02341066 and PF-00299804 are drugs that specifically target certain proteins that may be more active in cancer cells than normal cells, in particular in non-small cell lung cancer. Both drugs seem to be able to stop the growth of or kill cancer cells. Researchers want to combine them to see if they are a safe and effective treatment for advanced non-small cell lung cancer.

Objectives:

\- To test the safety and effectiveness of PF-02341066 and PF-00299804 for advanced non-small cell lung cancer.

Eligibility:

\- Individuals at least 18 years of age with advanced non-small cell lung cancer that has not responded to standard treatments.

Design:

* Participants will be screened with a medical history and physical exam. They will also have blood and urine tests, and imaging studies. Heart and lung function tests and an eye exam may also be given.
* The first cycle of treatment will be 28 days. Every cycle after the first will be 21 days. Participants may have up to 17 cycles of treatment.
* Participants will take both study drugs as tablets. Twelve hours after the first dose, participants will take only the PF-02341066. This dose schedule will remain the same throughout the study.
* Participants will be monitored with frequent blood and urine tests and imaging studies. Tumor biopsies will be taken as needed. Those in the study will keep a diary to record any symptoms or side effects of taking the study drugs.
* After 17 cycles of treatment, or after stopping the study drugs early for any other reason, participants will have a final followup visit.

Conditions

  • Carcinoma, Non-Small Cell Lung
  • Adenocarcinoma
  • Carcinoma, Squamous Cell
  • Carcinoma, Large Cell

Interventions

DRUG

PF-02341066/PF-00299804

Combined PF-02341066 and PF-00299804

DRUG

PF-02341066/PF-00299804

Single Agent PF-00299804 followed by Combined PF-02341066 and PF-00299804

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Arun Rajan, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-01
Primary Completion
2014-02-28
Completion
2015-02-26

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01441128 on ClinicalTrials.gov