TerminatedPhase 1

A Study Of PF-06664178 In Patients With Advanced Solid Tumors

Stopped: The study was prematurely discontinued due to a business-related decision on 09-FEB-2016. The decision to terminate the trial was based on the overall results.

United States31 participantsStarted 2014-08

Plain-language summary

To assess the safety and tolerability at increasing dose levels of PF-06664178 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

Who can participate

Age range18 Years

SexALL

See this in plain English?

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

Inclusion Criteria: * Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for whom no standard therapy is available * Performance Status of 0 or 1 * Adequate bone marrow, kidney and liver function * Part 2 includes target expressing NSCLC, ovarian or breast cancer patients Exclusion Criteria: * Brain metastases requiring steroids * Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start (6 weeks for mitomycin C or nitrosoureas) * Active and clinically significant bacterial, fungal, or viral infection

What they're measuring

First Cycle Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated Dose(MTD)

Timeframe: Day 1 up to Day 21

Number of Patients With All-Causality Treatment-Emergent Adverse Events(TEAEs) [Part 2 & 3]

Timeframe: Day 1 up to Day 21

Number of Participants With Laboratory Abnormalities [Part 2 & 3]

Timeframe: On Day1, Day4, Day8, Day15 of the first cycle; on Day1, Day8, Day15 of the second cycle; on Day 1 of the subsequent cycles; end of treatment visit(no longer than 1 week after the patient has been discontinued)

Trial details

NCT IDNCT02122146

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-06

Results submitted2017-04-25

View on ClinicalTrials.gov More Neoplasms trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

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

What they're measuring

First Cycle Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated Dose(MTD)

Timeframe: Day 1 up to Day 21

Number of Patients With All-Causality Treatment-Emergent Adverse Events(TEAEs) [Part 2 & 3]

Timeframe: Day 1 up to Day 21

Number of Participants With Laboratory Abnormalities [Part 2 & 3]