Status:
TERMINATED
Treatment Resistance Following Anti-cancer Therapies
Lead Sponsor:
Pfizer
Conditions:
Disease Progression
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The TRANSLATE study aims to better understand why tumors become resistant to standard anti-cancer therapies. New tumor biopsy and blood samples are collected after disease progression on standard-of-...
Detailed Description
Background: Development of new cancer treatments requires better understanding of why tumors develop resistance to standard-of-care (SOC) therapies. However, post-progression tumor biopsies are not ro...
Eligibility Criteria
Inclusion
- Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumors treated as follows:
- Non small cell lung carcinoma (NSCLC) monotherapy: Disease progression (PD) on 1st line monotherapy anti PD-1/ L1.
- NSCLC combination: PD on 1st line anti PD-1/ L1 plus standard doublet platinum containing regimen; or PD on 1st-line anti-PD-1/-L1 plus standard doublet platinum-containing regimen followed by continuation of single agent anti-PD-1/-L1).
- Renal cell carcinoma (RCC) with clear cell component: 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; or PD on 1st-line combination of avelumab with axitinib or pembrolizumab with axitinib.
- HR+ HER2 adenocarcinoma of the breast: PD on 1st line combination of doublet palbociclib with hormonal therapy.
- Castrate resistant adenocarcinoma of the prostate: PD on enzalutamide monotherapy.
- Castrate resistant adenocarcinoma of the prostate: PD on abiraterone in combination with prednisone.
- germline mutated BRCA (gBRCAm), HER2- breast cancer: PD on a PARP inhibitor monotherapy in patients previously treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting.
- Radiographic evidence of PD, including the target lesion being subjected to biopsy for the study, on the most recent regimen that requires a change in anti-cancer treatment.
Exclusion
- Tumor biopsy taken from a bone or an irradiated target lesion.
- Discontinuation of current or most recent anti cancer therapy due to toxicity and not progressive disease.
- Initiation of new anti-cancer therapy after disease progression prior to planned biopsy.
Key Trial Info
Start Date :
February 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2020
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04436120
Start Date
February 13 2019
End Date
December 14 2020
Last Update
December 3 2024
Active Locations (33)
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1
Southern Cancer Center, P.C.
Daphne, Alabama, United States, 36526
2
Southern Cancer Center, PC
Mobile, Alabama, United States, 36607
3
Southern Cancer Center, PC
Mobile, Alabama, United States, 36608
4
Alaska Urological Institute dba Alaska Clinical Research Center
Anchorage, Alaska, United States, 99503