Ignite Creation Date:
2024-05-06 @ 2:49 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04436120
Status:
TERMINATED
Last Update Posted:
2021-05-14
First Post:
2020-06-09
Brief Title:
Treatment Resistance Following Anti-cancer Therapies
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
TREATMENT RESISTANCE FOLLOWING ANTI-CANCER THERAPIES TRANSLATE
Status:
TERMINATED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated due to lack of enrollment that has been compounded by the global COVID-19 pandemic There were no safety andor efficacy concerns involved in the decision to stop enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-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
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
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 routinely collected limiting the tissue available to characterize mechanisms of treatment resistance The TRANSLATE clinical study is specifically designed to address these critical gaps
Trial design TRANSLATE is a global multicenter translational study designed to collect and compare archival pre-treatment tumor tissue with paired de novo tumor and blood samples obtained following disease progression on SOC therapies targeting therapeutically important areas of cancer biology
Eligible Tumor Type and Most Recent SOC Therapy
Non-small-cell lung and Anti-PD-1-L1 monotherapy
Non-small-cell lung and Anti-PD-1-L1 platinum
Clear cell renal cell carcinoma and Anti-PD-1-L1 monotherapy
Clear cell renal cell carcinoma and Doublet anti-PD-1-L1 anti-CTLA-4
Clear cell renal cell carcinoma and Pembrolizumab axitinib
Clear cell renal cell carcinoma and Avelumab axitinib
HR HER2- breast and Palbociclib hormonal therapy
germline mutated BRCA breast and Olaparib or talazoparib monotherapy
Castration-resistant prostate and Enzalutamide
Castration-resistant prostate and Abiraterone prednisone
Eligibility criteria include adults with locally advanced or metastatic tumors radiographic evidence of progressive disease during the most recent SOC regimen sufficient archival tumor tissue and a post-progression tumor lesion that is safely accessible for a new biopsy
The results from clinical NGS panel testing may help inform subsequent treatment plan or identification of relevant interventional clinical trials
Patients are enrolled after disease progression on SOC and before change in treatment and participate in 3 study visits within approximately 3 months
Next-generation sequencing results from analysis of tumor tissue and blood will be returned to the study physician and patient for review at a subsequent study visit within this timeframe
The primary endpoint is the change in frequency of gene alterations between pre-treatment and post-progression tumor biopsies Secondary endpoints address prioritized scientific hypotheses specific to each target area of biology and indication
Primary data will be publicly available after the study to support further research
Sponsored by Pfizer Inc EudraCT 2018-003612-45
Trial design TRANSLATE is a global multicenter translational study designed to collect and compare archival pre-treatment tumor tissue with paired de novo tumor and blood samples obtained following disease progression on SOC therapies targeting therapeutically important areas of cancer biology
Eligible Tumor Type and Most Recent SOC Therapy
Non-small-cell lung and Anti-PD-1-L1 monotherapy
Non-small-cell lung and Anti-PD-1-L1 platinum
Clear cell renal cell carcinoma and Anti-PD-1-L1 monotherapy
Clear cell renal cell carcinoma and Doublet anti-PD-1-L1 anti-CTLA-4
Clear cell renal cell carcinoma and Pembrolizumab axitinib
Clear cell renal cell carcinoma and Avelumab axitinib
HR HER2- breast and Palbociclib hormonal therapy
germline mutated BRCA breast and Olaparib or talazoparib monotherapy
Castration-resistant prostate and Enzalutamide
Castration-resistant prostate and Abiraterone prednisone
Eligibility criteria include adults with locally advanced or metastatic tumors radiographic evidence of progressive disease during the most recent SOC regimen sufficient archival tumor tissue and a post-progression tumor lesion that is safely accessible for a new biopsy
The results from clinical NGS panel testing may help inform subsequent treatment plan or identification of relevant interventional clinical trials
Patients are enrolled after disease progression on SOC and before change in treatment and participate in 3 study visits within approximately 3 months
Next-generation sequencing results from analysis of tumor tissue and blood will be returned to the study physician and patient for review at a subsequent study visit within this timeframe
The primary endpoint is the change in frequency of gene alterations between pre-treatment and post-progression tumor biopsies Secondary endpoints address prioritized scientific hypotheses specific to each target area of biology and indication
Primary data will be publicly available after the study to support further research
Sponsored by Pfizer Inc EudraCT 2018-003612-45
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TRANSLATE | OTHER | None | None |
| 2018-003612-45 | EUDRACT_NUMBER | Alias Study Number | None |