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

Trial ID or NCT#

NCT02222922

Status

not recruiting iconNOT 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: No
Inclusion Criteria:
  1. - 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:
  1. - 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)

Heather Wakelee
Heather Wakelee
Medical oncologist, Thoracic specialist
Winston Chen and Phyllis Huang Professor
Melinda L. Telli, M.D.
Melinda L. Telli, M.D.
Medical oncologist, Breast specialist
Professor of Medicine (Oncology)

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Contact

ccto
ccto-office@stanford.edu