TREATMENT RESISTANCE FOLLOWING ANTI-CANCER THERAPIES (TRANSLATE)

Pfizer Inc.0 sites550 target enrollmentApril 10, 2019

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Pfizer Inc.
Enrollment: 550
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 10, 2019

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Pfizer Inc.

Eligibility Criteria

Inclusion Criteria

•1\. Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumors treated as follows:
•a. NSCLC monotherapy (Cohort 1\):
•\- Disease progression (PD) on 1st\-line monotherapy anti\-PD\-1/\-L1\.
•b. NSCLC combination (Cohort 2\):
•\- PD on 1st\-line anti\-PD\-1/\-L1 plus standard doublet platinum\-containing regimen.
•c. Renal cell carcinoma (RCC) with clear cell component (Cohort 3\):
•\- PD on 2nd\-line monotherapy anti\-PD\-1/\-L1; or
•\- PD on 1st\-line combination of doublet anti\- PD\-1/\-L1 with anti\-CTLA\-4\.
•d. HR\+ HER2\- breast cancer (Cohort 4\):
•\- PD on 1st\-line combination of doublet palbociclib with hormonal therapy.

Exclusion Criteria

•1\. Discontinuation of current or most recent anti\-cancer therapy due to toxicity and not progressive disease.
•2\. Initiation of new anti\-cancer therapy after PD prior to planned biopsy.
•3\. Any medical condition that, in the investigator’s judgement, unacceptably increases risk associated with the tumor biopsy or blood sampling procedures (eg, evidence of inadequate wound healing, significant neutropenia or thrombocytopenia, recent
•history of clinically significant bleeding or tumor hemorrhage).
•4\. Cohorts 1, 2 and 3 (NSCLC monotherapy, NSCLC combination, RCC with clear cell component) only: Treatment with an anti\-PD\-1/\-L1 agent prior to current or most recent anti\-PD\-1/\-L1 therapy.
•5\. Cohort 4 (HR\+ HER2\- breast cancer) only: Treatment with a CDK 4/6 inhibitor prior to current or most recent CDK 4/6 inhibitor.
•6\. Cohort 5 (castrate\-resistant prostate cancer) only: Treatment with an agent that blocks adrenal androgen synthesis (eg, abiraterone acetate) or second\-generation AR antagonist.
•7\. Patients who are investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees, including their family members, directly involved in the conduct of the study.
•8\. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.