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BRIEF TITLE: 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

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


  • Org Study ID: C3851001
  • Secondary ID:
  • NCT ID: NCT03854227
  • NCT Alias:
  • Sponsor: Pfizer - Industry
  • Source: 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.

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

Primary Outcomes:

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

Primary Outcome 1 - Time Frame: Baseline through day 28

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

Primary Outcome 2 - Time Frame: Baseline through approximately 2 years

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

Primary Outcome 3 - Time Frame: Baseline through approximately 2 years

Condition:

  • Advanced Solid Tumors
  • Metastatic Solid Tumors

Eligibility

Criteria:
Inclusion Criteria:

- Participants who are intolerant or resistant to standard treatment for selected solid
tumors

- 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

- Known or suspected hypersensitivity to PF-06939999

- Inability to consume or absorb study drug
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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.

Location

Facility Status Contact
NEXT Oncology
San Antonio, Texas 78229
United States
Recruiting