Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Carcinoma

Prostatic Neoplasms

Adenocarcinoma

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Colorectal Neoplasms

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Melanoma

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Mesothelioma

Mesothelioma, Malignant

Neoplasms, Squamous Cell

Neoplasms by Histologic Type

Skin Diseases

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms, Mesothelial

Breast Diseases

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Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

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Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Prostatic Diseases

Pancreatic Cancer

Malignant Mesothelioma

All Drugs and Chemicals

Mitogens

PF-06952229 at 375 mg BID in combination with enzalutamide

PF-06952229 at 500 mg BID in combination with enzalutamide

PF-06952229 at 625 mg BID in combination with enzalutamide

PF-06952229 at 750 mg BID in combination with enzalutamide

PF-06952229 at recommended Phase 2 Dose BID

PF-06952229 at recommended phase 2 dose BID in combination with enzalutamide

Oral 7 days on / 7 days off - 28 day cycles (Part 1)

PF-06952229

Prostate Cancer (Part 2). 160mg, capsules, orally, daily

Enzalutamide

Pfizer CT.gov Call Center

A Phase 1 dose escalation and expansion study evaluating safety, tolerability and pharmacokinetics of PF-06952229 in adult patients with advanced solid tumors.

This is a Phase 1, open label, multi center, multiple dose, dose escalation and expansion, safety, tolerability, PK, and pharmacodynamics study of PF 06952229 in previously treated patients with advanced or metastatic cancers that may have high TGFbeta signatures and EMT expression.

The study includes Parts 1A and 1B, which are dose-escalation for monotherapy and combination therapy with enzalutamide, respectively, and Parts 2A and 2B, which are dose expansion for monotherapy and combination therapy with enzalutamide, respectively.

PF-06952229 Treatment in Adult Patients With Advanced Solid Tumors

A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY EVALUATING SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF 06952229 IN ADULT PATIENTS WITH ADVANCED SOLID TUMORS

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

First cycle DLTs will be utilized to determine the max tolerated dose and future escalations or deescalations. A DLT is any of the predefined set of unacceptable adverse events observed and at least possibly related to investigational agents.

Treatment-related AE is any untoward medical occurrence attributed to study drug in a participant who received study drug.

Laboratory parameters may include: hematology (hemoglobin, hematocrit, red blood cell, platelet and white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen, creatinine, sodium, potassium, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein and serum pregnancy test \[for all female participants\]) and urine (urine pregnancy test \[for all female participants\]). Clinical significance of laboratory parameters was determined at the investigator's discretion.

Prostate-specific antigen decline by more than 50% from baseline

Tumor assessment per prostate cancer working group 2 and RECIST v1.1

Single dose and multiple dose PK will be calculated as data permits including Maximum Observed Plasma Concentration (Cmax).

Single dose and multiple dose PK will be calculated as data permits including Time to Reach Maximum Observed Plasma Concentration (Tmax).

Single dose and multiple dose PK will be calculated as data permits including Area Under the Curve (AUC).

Single dose and multiple dose PK will be calculated as data permits including Apparent Oral Clearance (CL/F). Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

Single dose and multiple dose PK will be calculated as data permits including Apparent Volume of Distribution (Vz/F). Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.

The time it takes for the concentration of the study drug in plasma to be reduced by 50%

Prostate-specific antigen decline by more than 50% from baseline.

Number of Participants With Tumor Reponse per PCWG2 and RECIST v1.1

Proportion of patients with a reduction in tumor burden as defined by RECIST 1.1. and PWG3 response criteria.

Time of initial response until documented tumor progression.

The time from Cycle 1 Day 1 dose administration to disease progression or death from any cause.

Time from Cycle 1 Day 1 until death from any cause.

Time from Cycle 1 Day 1 until objective tumor progression.

Time from Cycle 1 Day 1 to objective tumor response.

As data permit, levels of intra-tumor T cells, such as CD8 IHC, will be assessed.

Spots Global Cancer Trial Database for PF-06952229 Treatment in Adult Patients With Advanced Solid Tumors

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