Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Dose Escalation
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Escalation
Participants will receive PF-06939999 orally at escalating doses in 28 day cycles on a continuous basis
  • Drug: PF-06939999 dose escalation
    PF-06939999 orally at escalating doses on a continuous basis
    Other names:
    • PRMT5 inhibitor
Experimental
Non small cell lung cancer monotherapy
Participants will receive PF-06939999 at the recommended Phase 2 dose in 28 day cycles on a continuous basis
  • Drug: PF-06939999 monotherapy
    PF-06939999 at the recommended Phase 2 dose orally on a continuous basis
    Other names:
    • PRMT5 inhibitor
Experimental
Urothelial carcinoma
Participants will receive PF-06939999 at the recommended Phase 2 dose in 28 day cycles on a continuous basis
  • Drug: PF-06939999 monotherapy
    PF-06939999 at the recommended Phase 2 dose orally on a continuous basis
    Other names:
    • PRMT5 inhibitor
Experimental
Head and neck squamous cell carcinoma
Participants will receive PF-06939999 at the recommended Phase 2 dose in 28 day cycles on a continuous basis
  • Drug: PF-06939999 monotherapy
    PF-06939999 at the recommended Phase 2 dose orally on a continuous basis
    Other names:
    • PRMT5 inhibitor
Experimental
Non small cell lung cancer PF-06939999 plus docetaxel
Participants will receive PF-06939999 on a continuous basis in combination with docetaxel
  • Drug: PF-06939999 in combination with docetaxel
    PF-06939999 orally on a continuous basis in combination with docetaxel
    Other names:
    • PRMT5 inhibitor
Experimental
Non small cell lung cancer dose finding
Participants will receive PF-06939999 on a continuous basis at escalating doses in combination with docetaxel
  • Drug: PF-06939999 in combination with docetaxel
    PF-06939999 orally on a continuous basis in combination with docetaxel
    Other names:
    • PRMT5 inhibitor

Recruiting Locations

Henry-Joyce Cancer Clinic
Nashville, Tennessee 37232

Oncology IDS Pharmacy
Nashville, Tennessee 37232

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.