CompletedPhase 1

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

United States, Spain138 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 range

18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Trial details

NCT IDNCT02222922

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-11-05

Results submitted2020-10-29

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