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A Study Of PF-06647020 For Adult Patients With Advanced Solid Tumors
Not Recruiting
Trial ID: NCT02222922
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
Stanford Investigator(s)
Melinda L. Telli, M.D.
Professor of Medicine (Oncology)
Heather Wakelee
Winston Chen and Phyllis Huang Professor
Eligibility
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
Intervention(s):
drug: fluconazole
drug: PF-06647020 Q3W
drug: PF-06647020 Q2W
drug: PF-06647020 combined with Avelumab
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
ccto
6504987061