A Study Of PF-06647020 For Adult Patients With Advanced Solid Tumors
Trial ID or NCT#
NCT02222922
Status
NOT RECRUITING
Purpose
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.
Official Title
A FIRST-IN-HUMAN PHASE 1, DOSE ESCALATION, SAFETY AND PHARMACOKINETIC STUDY OF PF-06647020 IN ADULT PATIENTS WITH ADVANCED SOLID TUMORS
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
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
Investigator(s)
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Contact
ccto
6504987061
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