TerminatedPhase 1

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

United States20 participantsStarted 2011-09-01

Plain-language 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.

Who can participate

Age range18 Years – 99 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: * Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator s study team before subjects are included in the study. * Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. * Subjects must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. * Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: * Disease Criteria: * Dose Escalation Phase: Histologically proven diagnosis of NSCLC that is locally advanced or metastatic, after failure of either at least one prior chemotherapy regimen or targeted therapy. * Expansion Phase: Histologically proven diagnosis of NSCLC that is locally advanced or metastatic and with acquired resistance to erlotinib or gefitinib. Acquired resistance is defined as progression following either an initial response (complete or partial), or stable disease for at least six months, while on single agent erlotinib or single agent gefitinib. In addition to these patients, Cohort 2 will also enroll patients from ongoing trials, including A7471017 and A7471028, who have progressed on single agent PF-00299804. * For the dose escalation phase, any prior treatment (chemotherapy, targeted therapy, radiation or surgery) must have been completed…

What they're measuring

Overall safety profile of combined PF 02341066 plus PF 00299804 including adverse events (AE), as defined and graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], and first cycle Dose Limiting Tox...

Timeframe: 18 months

Trial details

NCT IDNCT01441128

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2014-02-28