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)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

Melinda L. Telli, M.D.
Melinda L. Telli, M.D.

Professor of Medicine (Oncology)

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
ccto-office@stanford.edu

New Trial Alerts