Vanderbilt Clinical Trials

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

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

Advanced Solid Tumors
Metastatic Solid Tumors

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: Parallel Assignment
Intervention Model Description: Dose Escalation and Dose expansion
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned 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

More Details

Status: Terminated
Sponsor: Pfizer

Study Contact

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.