Disease Progression Clinical Trial
Official title:
TREATMENT RESISTANCE FOLLOWING ANTI-CANCER THERAPIES (TRANSLATE)
Verified date | May 2021 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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-care anti-cancer treatment and compared to the initial (archival) tumor biopsy sample taken from the same patient. Annotated reports of results from clinical Next Generation Sequencing (NGS) gene panel tests of both tumor and blood are sent directly from the testing lab to the study physician for discussion with the patient during the study. Patients may participate in interventional treatment clinical trials at the same time as participating in the TRANSLATE study. Primary data will be publicly available after the study to support further research.
Status | Terminated |
Enrollment | 38 |
Est. completion date | December 14, 2020 |
Est. primary completion date | December 14, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Argentina | Hospital Britanico de Buenos Aires | Caba | |
Argentina | Centro de Educacion Medica e Investigaciones Clinicas"Norberto Quirno" CEMIC | Ciudad Autónoma de Bs As | |
Argentina | Sanatorio de la Mujer | Rosario | Santa FÉ |
Argentina | Clínica Viedma S.A. | Viedma | RIO Negro |
Belgium | Grand Hôpital de Charleroi - Site Notre Dame | Charleroi | |
Belgium | AZ Maria Middelares | Gent | |
Belgium | UZ Gent | Gent | |
Belgium | Hôpital de Jolimont | Haine-Saint-Paul | |
Belgium | Clinique Saint-Pierre Ottignies | Ottignies | |
France | Centre Jean Perrin | Clermont Ferrand | |
France | Hôpitaux Civils de Colmar, Centre Hospitalier Louis Pasteur | Colmar | |
France | CHU Henri Mondor | Créteil | |
France | Hôpital La Croix du Sud | Quint Fonsegrives | |
France | Institut Jean Godinot | Reims Cedex | |
France | Hopital Bégin | Saint-Mande | |
United Kingdom | Royal Cornwall Hospital | Cornwall | |
United States | Alaska Urological Institute dba Alaska Clinical Research Center | Anchorage | Alaska |
United States | Southern Cancer Center, P.C. | Daphne | Alabama |
United States | The Oncology Institute of Hope Innovation | Glendale | California |
United States | The Oncology Institute of Hope Innovation | Long Beach | California |
United States | Southern Cancer Center, PC | Mobile | Alabama |
United States | Southern Cancer Center, PC | Mobile | Alabama |
United States | UCI Medical Center-Chao Family Comprehensive Cancer Center | Orange | California |
United States | Woodlands Medical Specialists PA | Pensacola | Florida |
United States | The Oncology Institute of Hope Innovation | Santa Ana | California |
United States | Sansum Clinic | Santa Barbara | California |
United States | Seattle Cancer Care Alliance | Seattle | Washington |
United States | University of Washington Medical Center | Seattle | Washington |
United States | Sansum Clinic | Solvang | California |
United States | Arizona Oncology Associates, PC - HOPE | Tucson | Arizona |
United States | Arizona Oncology Associates, PC-HOPE | Tucson | Arizona |
United States | ICRI-Administrative and Supplies Only | Whittier | California |
United States | The Oncology Institute of Hope and Innovation | Whittier | California |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States, Argentina, Belgium, France, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the frequency of gene alterations between pre treatment tumor samples and post progression tumor biopsies | Through study completion, approximately 3 months | ||
Secondary | Proportion of patients with fully evaluable archival and post progression tumor biopsy (eg, sample sufficient for all intended analyses at all measured time points) | Through study completion, approximately 3 months | ||
Secondary | Concordance of gene alterations between post progression biopsy tissue and blood NGS results | Through study completion, approximately 3 months | ||
Secondary | Change in the frequency of alterations in genes encoding HLA, Beta-2 Microglobulin, STAT1, JAK1, JAK2, IFN-gamma and IFN- gamma R between pre treatment archival and post progression samples | Through study completion, approximately 3 months | ||
Secondary | Frequency of alterations in genes encoding HLA, Beta 2 Microglobulin, STAT1, JAK1, JAK2, IFN-gamma and IFNGR in cfDNA | Through study completion, approximately 3 months | ||
Secondary | Change in the frequency of RB1 gene alterations between pre treatment archival and post progression samples | Through study completion, approximately 3 months | ||
Secondary | Frequency of RB1 gene alterations in cfDNA | Through study completion, approximately 3 months | ||
Secondary | Change in the frequency of AR gene alterations between pre treatment archival and post progression samples | Through study completion, approximately 3 months | ||
Secondary | Frequency of AR gene alterations in cfDNA | Through study completion, approximately 3 months | ||
Secondary | Changes in the expression of nuclear hormone receptors or related RNA signatures reflecting nuclear receptor pathway activity between pre treatment archival and post progression samples | Through study completion, approximately 3 months | ||
Secondary | Change in the frequency of somatic reversion alterations in gBRCA mutant allele between pre treatment archival and post progression samples | Through study completion, approximately 3 months |
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