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

  • Interventional
  • Recruiting
  • NCT02222922
Eligibility Details Visit Clinicaltrials.gov

A FIRST-IN-HUMAN PHASE 1, DOSE ESCALATION, SAFETY AND PHARMACOKINETIC STUDY OF PF-06647020 IN ADULT PATIENTS WITH ADVANCED SOLID TUMORS

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT02222922

IRB#IRB14-0987

Lead SponsorPfizer

Lead PhysicianJyoti Patel

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting