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Brief Title: A Dose Escalation Study Of PF-06939999 In Participants With Advanced Or Metastatic Solid Tumors

A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ESCALATING DOSES OF PF-06939999 (PRMT5 INHIBITOR) IN PARTICIPANTS WITH ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER, HEAD AND NECK SQUAMOUS CELL CARCINOMA, ESOPHAGEAL CANCER, ENDOMETRIAL CANCER, CERVICAL CANCER AND BLADDER CANCER

INTRODUCTION

  • Org Study ID: C3851001
  • Secondary ID: N/A
  • NTC ID: NCT03854227
  • Sponsor: Pfizer

BRIEF SUMMARY


This is a Phase 1, open label, multi center, dose escalation and expansion, safety,
tolerability, PK, and pharmacodynamics study of PF 06939999 in previously treated patients
with advanced or metastatic cancer.


  • Overall Status
    Recruiting
  • Start Date
    March 14, 2019
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of participants with dose limiting toxicities (DLTs)

Primary Outcome 1 - Timeframe: Baseline through day 28

Primary Outcome 2 - Measure: Number of participants with treatment emergent adverse events (AEs)

Primary Outcome 2 - Timeframe: Baseline through up to 2 years or until disease progression

Primary Outcome 3 - Measure: Number of participants with laboratory abnormalities

Primary Outcome 3 - Timeframe: Baseline through up to 2 years or until disease progression

Primary Outcome 4 - Measure: Objective Response Rate

Primary Outcome 4 - Timeframe: Baseline through up to 2 years or until disease progression

CONDITION

  • Advanced Solid Tumors
  • Metastatic Solid Tumors

ELIGIBILITY


Inclusion Criteria:

- Histologically or cytologically confirmed locally advanced or metastatic NSCLC,
urothelial carcinoma or HNSCC

- Progressed after at least 1 line of treatment and no more than 3 lines of treatment

- At least one measurable lesion as defined by RECIST version 1.1

- ECOG Performance Status 0 or 1

- Adequate Bone Marrow Function

- Adequate Renal Function

- Adequate Liver Function

- Resolved acute effects of any prior therapy

Exclusion Criteria:

- Known active uncontrolled or symptomatic CNS metastases.

- Major surgery, radiation therapy, systemic anti-cancer therapy or investigational
drug(s) within 4 weeks prior to study entry.

- Active, uncontrolled infection, including COVID-19

- Known or suspected hypersensitivity to PF-06939999

- Inability to consume or absorb study drug

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Pfizer CT.gov Call Center

Role: Study Director

Affiliation: Pfizer

Overall Contact

Name: Pfizer CT.gov Call Center

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

LOCATION

Facility Status Contact
Facility: Scottsdale Healthcare Hospitals d/b/a HonorHealth
Scottsdale, Arizona 85258
United States
Status: Recruiting Contact: N/A
Facility: Virginia G. Piper Cancer Pharmacy
Scottsdale, Arizona 85258
United States
Status: Recruiting Contact: N/A
Facility: Keck Hospital of USC
Los Angeles, California 90033
United States
Status: Recruiting Contact: N/A
Facility: LAC + USC Medical Center
Los Angeles, California 90033
United States
Status: Recruiting Contact: N/A
Facility: USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Status: Recruiting Contact: N/A
Facility: Keck Medical Center of USC Pasadena
Pasadena, California 91105
United States
Status: Recruiting Contact: N/A
Facility: AdventHealth Celebration Infusion Center
Celebration, Florida 34747
United States
Status: Recruiting Contact: N/A
Facility: AdventHealth Medical Group Oncology Research at Celebration
Celebration, Florida 34747
United States
Status: Recruiting Contact: N/A
Facility: University Of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center
Miami, Florida 33136
United States
Status: Recruiting Contact: N/A
Facility: AdventHealth Hematology and Oncology
Orlando, Florida 32804
United States
Status: Recruiting Contact: N/A
Facility: AdventHealth Orlando - Investigational Drug Services
Orlando, Florida 32804
United States
Status: Recruiting Contact: N/A
Facility: AdventHealth Orlando Infusion Center
Orlando, Florida 32804
United States
Status: Recruiting Contact: N/A
Facility: Henry-Joyce Cancer Clinic
Nashville, Tennessee 37232
United States
Status: Recruiting Contact: N/A
Facility: Oncology IDS Pharmacy
Nashville, Tennessee 37232
United States
Status: Recruiting Contact: N/A
Facility: The University of Texas
Houston, Texas 77030
United States
Status: Recruiting Contact: N/A
Facility: NEXT Oncology
San Antonio, Texas 78229
United States
Status: Recruiting Contact: N/A
Facility: Seattle Cancer Care Alliance
Seattle, Washington 98109
United States
Status: Recruiting Contact: N/A
Facility: University of Washington Medical Center
Seattle, Washington 98195
United States
Status: Recruiting Contact: N/A