CompletedPhase 1

A Study Of PF-06647020 For Adult Patients With Advanced Solid Tumors

United States138 participantsStarted 2014-10-17

Plain-language summary

To assess the safety and tolerability at increasing dose levels of PF-06647020 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

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

Q2W Inclusion Criteria: * Diagnosis of platinum resistant or refractory OVCA having received 2 or fewer prior lines, or recurrent advanced NSCLC having received 3 or fewer prior lines * Performance Status of 0, 1, or 2 * Adequate bone marrow, kidney, and liver function Q2W Exclusion Criteria: * OVCA pts excluded with any of the following: non-epithelial, including malignant mixed mullerian tumors, unresolved bowel obstruction * Brain metastases requiring steroids * Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start * Active and clinically significant bacterial, fungal, or viral infection Q3W 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 ovarian cancer, target expressing triple negative breast cancer and non small cell lung cancer patients Q3W Exclusion Criteria: * OVCA pts excluded with any of the following: non-epithelial, including malignant mixed mullerian tumors, prior radiotherapy to pelvis/abdomen, pts with CA-125 only disease, unresolved bowel obstruction * Brain metastases requiring steroids * Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start * Active and clinically significant bacterial, fungal, or viral infection

What they're measuring

Number of Participants With Dose Limiting Toxicities (DLTs) - Q3W Regimen

Timeframe: First Cycle, Day 1 up to Day 21

Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality)

Timeframe: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months)

Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related)

Timeframe: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months)

Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)

Timeframe: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months)

Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen

Timeframe: From baseline to end of treatment (approximately 32 months).

Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen

Timeframe: From baseline to end of treatment (approximately 32 months).

Trial details

NCT IDNCT02222922

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-11-05

Results submitted2020-10-29

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