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BRIEF TITLE: STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ESCALATING DOSES OF PF-06940434 IN PATIENTS WITH ADVANCED OR METASTATIC SOLID TUMORS

A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ESCALATING DOSES OF PF-06940434 IN PATIENTS WITH ADVANCED OR METASTATIC SOLID TUMORS


  • Org Study ID: C3891001
  • Secondary ID: 2020-004009-29
  • NCT ID: NCT04152018
  • NCT Alias:
  • Sponsor: Pfizer - Industry
  • Source: Pfizer

Brief Summary

Open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamics and clinical activity study of PF-06940434 in patients with SCCHN (Squamous Cell Carcinoma of the Head and Neck), renal cell carcinoma (RCC - clear cell and papillary), ovarian, gastric, esophageal, esophageal (adeno and squamous), lung squamous cell, pancreatic and biliary duct, endometrial, melanoma and urothelial tumors. This study contains two parts, single agent dose escalation (Part 1A), dose finding of PF 06940434 in combination with anti-PD-1 (Part 1B), biopsy cohorts with monotherapy lead-in at the maximum tolerated dose (MTD) or maximum administered dose (MAD), followed by combination of anti-PD-1 [PF-06801591] (Part 1C) followed by dose expansion (Part 2). Part 2 Dose Combination Expansion will enroll participants into 2 cohorts at doses determined from Part 1B in order to further evaluate the safety of PF-06940434 in combination with anti-PD-1.

Overal Status Start Date Phase Study Type
Recruiting November 13, 2019 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Number of participants with Dose-limiting toxicities (DLT) for Dose Escalation and Dose Finding

Primary Outcome 1 - Time Frame: Baseline up to 28 Days (Cycle 1)

Primary Outcome 2 - Measure: Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities

Primary Outcome 2 - Time Frame: Baseline up to approximately 24 months

Primary Outcome 3 - Measure: Number of Participants With Adverse Events (AEs) According to Severity

Primary Outcome 3 - Time Frame: Baseline up to approximately 24 months

Primary Outcome 4 - Measure: Number of Participants With Adverse Events (AEs) According to Seriousness

Primary Outcome 4 - Time Frame: Baseline up to up to approximately 24 months

Primary Outcome 5 - Measure: Number of Participants With Adverse Events (AEs) by Relationship

Primary Outcome 5 - Time Frame: Baseline up to approximately 24 months

Primary Outcome 6 - Measure: Progression-Free Survival (PFS) for Dose Expansion

Primary Outcome 6 - Time Frame: Baseline up to 24 Months

Primary Outcome 7 - Measure: Objective Response Rate - Percentage of Participants With Objective Response in Dose Expansion

Primary Outcome 7 - Time Frame: Baseline up to 24 months

Primary Outcome 8 - Measure: Duration of Response (DR) for Dose Expansion

Primary Outcome 8 - Time Frame: Baseline up to 24 Months

Condition:

  • Squamous Cell Carcinoma of the Head and Neck
  • Renal Cell Carcinoma
  • Ovarian Cancer
  • Gastric Cancer
  • Esophageal Cancer
  • Lung Squamous Cell Carcinoma
  • Pancreatic Cancer
  • Bile Duct Cancer
  • Endometrial Cancer
  • Melanoma Cancer
  • Urothelial Cancer

Eligibility

Criteria:
Inclusion Criteria:

- Histological or cytological diagnosis of SCCHN, RCC (clear cell and papillary cell),
ovarian, gastric, esophageal (adeno and squamous), lung squamous cell, pancreatic and
biliary duct, endometrial, melanoma, or urothelial cancer.

- Adequate bone marrow, kidney and liver function.

- Performance status of 0 or 1.

Exclusion Criteria:

- Participant disease status is suitable for local therapy administered with curative
intent.

- Hypertension that cannot be controlled by medications.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

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

Link: To obtain contact information for a study center near you, click here.

Locations

Facility Status Contact
Scottsdale Healthcare Hospitals DBA HonorHealth
Scottsdale, Arizona 85258
United States
Recruiting
Virginia G. Piper Cancer Pharmacy
Scottsdale, Arizona 85258
United States
Recruiting
Ronald Reagan UCLA Medical Center
Los Angeles, California 90095
United States
Not yet recruiting
UCLA Hematology Oncology
Los Angeles, California 90095
United States
Not yet recruiting
UCLA Hematology/Oncology
Los Angeles, California 90095
United States
Not yet recruiting
Siteman Cancer Center - West County
Creve Coeur, Missouri 63141
United States
Recruiting
Barnes-Jewish Hospital
Saint Louis, Missouri 63110
United States
Recruiting
Washington University School of Medicine Siteman Cancer Center
Saint Louis, Missouri 63110
United States
Recruiting
Siteman Cancer Center - South County
Saint Louis, Missouri 63129
United States
Recruiting
Siteman Cancer Center - North County
Saint Louis, Missouri 63136
United States
Recruiting
Siteman Cancer Center - St. Peters
Saint Peters, Missouri 63376
United States
Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Not yet recruiting
NEXT Oncology
San Antonio, Texas 78229
United States
Recruiting
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington 98109
United States
Recruiting