Disease ProgressionNCT04436120
Treatment Resistance Following Anti-cancer Therapies
A study testing De novo tumor tissue biopsy and Research blood draws in people with Disease Progression, run by Pfizer at 33 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disease Progression
- What is being tested?
- De novo tumor tissue biopsy and Research blood draws
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 33 sitesin 5 countries
- Study dates
- 13 Feb 2019to 14 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
33 sites in 5 countries.
33 sites in 5 countries
United States17 sites
Alaska Urological Institute dba Alaska Clinical Research Center
Anchorage, Alaska, 99503
Southern Cancer Center, P.C.
Daphne, Alabama, 36526
The Oncology Institute of Hope Innovation
Glendale, California, 91204
The Oncology Institute of Hope Innovation
Long Beach, California, 90805
Southern Cancer Center, PC
Mobile, Alabama, 36607
Southern Cancer Center, PC
Mobile, Alabama, 36608
UCI Medical Center-Chao Family Comprehensive Cancer Center
Orange, California, 92868-3201
Woodlands Medical Specialists PA
Pensacola, Florida, 32503
The Oncology Institute of Hope Innovation
Santa Ana, California, 92705
Sansum Clinic
Santa Barbara, California, 93105
Seattle Cancer Care Alliance
Seattle, Washington, 98109
University of Washington Medical Center
Seattle, Washington, 98195
Sansum Clinic
Solvang, California, 93463
Arizona Oncology Associates, PC-HOPE
Tucson, Arizona, 85704
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, 85711
The Oncology Institute of Hope and Innovation
Whittier, California, 90602
ICRI-Administrative and Supplies Only
Whittier, California, 90603
France6 sites
Centre Jean Perrin
Clermont-Ferrand, 63011
Hôpitaux Civils de Colmar, Centre Hospitalier Louis Pasteur
Colmar, 68024
CHU Henri Mondor
Créteil, 94010
Hôpital La Croix du Sud
Quint-Fonsegrives, 31130
Institut Jean Godinot
Reims, 51056
Hopital Bégin
Saint-Mandé, 94160
Belgium5 sites
Grand Hôpital de Charleroi - Site Notre Dame
Charleroi, 6000
AZ Maria Middelares
Ghent, 9000
UZ Gent
Ghent, 9000
Hôpital de Jolimont
Haine-Saint-Paul, 7100
Clinique Saint-Pierre Ottignies
Ottignies, 1340
Argentina4 sites
Hospital Britanico de Buenos Aires
CABA, C1280AEB
Centro de Educacion Medica e Investigaciones Clinicas"Norberto Quirno" CEMIC
Ciudad Autónoma de Bs As, C1431FWO
Sanatorio de la Mujer
Rosario, Santa Fe Province, S2000ORE
Clínica Viedma S.A.
Viedma, Río Negro Province, 8500
About this study
Official title: TREATMENT RESISTANCE FOLLOWING ANTI-CANCER THERAPIES (TRANSLATE)
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.
Read more
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.
Read the 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.
- Conditions
- Disease Progression
- Being tested
- De novo tumor tissue biopsy, Research blood draws
- Keywords
- Non Small Cell Lung Cancer, Renal Cell Carcinoma, HR+ HER2- Breast Cancer, Castrate-Resistant Prostate Cancer, Germline mutated BRCA, HER2- Breast Cancer
- Medical subject headings
- Disease Progression, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
De novo tumor tissue biopsyProcedure or surgery
De novo tissue biopsy performed following disease progression
Research blood drawsProcedure or surgery
Blood biospecimens collected following disease progression
| Study group | Role | What they receive |
|---|---|---|
| Tumor biopsy and blood draw | Other | Tumor biopsy and blood draw Receives: Procedure: De novo tumor tissue biopsy; Procedure: Research blood draws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Frequency of Gene Alterations Between Pre-treatment Tumor Samples (Archival) and Post-progression (De Novo) Tumor Biopsies
Change in frequency is calculated by (frequency in de novo samples) - (frequency in archival samples). The frequency of each gene alteration is calculated as number of patients who harbored the alteration divided by the total number of patients in the cohort. Only gene alterations with variant allele frequency of 5% or greater were included in the analysis. Two different sequencing techniques were applied so 2 analysis sets were repeated for each cohort: targeted panel next-generation sequencing (NGS) and whole exome sequencing NGS.
Measured: Through study completion, approximately 3 months
Secondary outcomes (7)
Number of Participants With Fully Evaluable Archival and Post-Progression Tumor Biopsy by Cohort
Estimating the number of fully biomarker evaluable population by cohort to evaluate the success rate in obtaining paired archival and post-progression tumor biopsies that were adequate to meet the objectives of the study
Measured: Through study completion, approximately 3 months
Overall Agreement Rate of Gene Alterations Between Post-Progression Tumor Biopsy and Blood NGS Results
Genetic alterations detected in blood were compared to those detected in tissue. Only gene alterations with frequency of 5% or greater based on assessment of tumor biopsy were included in the analysis.
Measured: Through study completion, approximately 3 months
Change in Frequency of RB1 Gene Alterations Between Pre-Treatment Archival and Post-Progression Samples
Mutations in RB1 gene associated with immune function, have also been shown to impact tumor immunogenicity and related with CDK4/6 inhibition. CDK4 or CDK6 complexed with cyclin D1 (CCND1) phosphorylates the retinoblastoma gene product (Rb), releasing the E2F and DP transcription factors that regulate the expression of genes required for entry into the S phase of the cell cycle.
Calculation of change in frequency was decribed in the primary endpoint (Outcome Measure 1).
Measured: Through study completion, approximately 3 months
Percentage of Participants Who Carried the RB1 Gene Alterations in Post-Progression Blood cfDNA
Mutations in RB1 gene associated with immune function, have also been shown to impact tumor immunogenicity and related with CDK4/6 inhibition. CDK4 or CDK6 complexed with cyclin D1 (CCND1) phosphorylates the retinoblastoma gene product (Rb), releasing the E2F and DP transcription factors that regulate the expression of genes required for entry into the S phase of the cell cycle. Percentage of Participants Who Carried the RB1 Gene Alterations in Post Progression Blood cfDNA analysis was only conducted for Cohort 4 as per protocol.
Measured: Through study completion, approximately 3 months
Change in Frequency of AR Gene Alterations Between Pre-Treatment Archival and Post-Progression Samples
Pre-treatment archival tumor samples and post-progression de novo tumor biopsies were analyzed to identify molecular markers of resistance to selected anti-cancer therapies.
Calculation of change in frequency was described for in the primary endpoint (Outcome Measure 1).
AR gene Alterations analysis was only conducted for the Cohorts 5 \& 6 as per protocol.
Measured: Through study completion, approximately 3 months
Percentage of Participants Who Carried the AR Gene Alterations in Post-Progression Blood cfDNA
Androgen receptor (AR) gene alterations can be evaluated as mechanisms of resistance to enzalutamide or abiraterone.
Percentage of Participants Who Carried the AR Gene Alterations in Post-Progression Blood cfDNA analysis was conducted as it was only applicable to Cohorts 5 \&6.
Measured: Through study completion, approximately 3 months
Change in Expression of Nuclear Hormone Receptors Between Pre-Treatment Archival and Post-Progression Samples
The differences in the expression of nuclear hormone receptor (HR) reflecting nuclear receptor pathway activity between the archival and de novo samples. Using HTG panel in BET [targeted tumor RNA (TTR)] population and Tempus RNAseq in BET [whole transcriptome tumor RNA (WTTR)] population. The unit of HTG expression data for nuclear hormone receptors is normalized expression counts. This Outcome Measure analysis was only conducted for Cohorts 5 \& 6 as per protocol.
Measured: Through study completion, approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start13 Feb 2019
- Primary completion14 Dec 2020
- Study completion14 Dec 2020
Why it stopped: Study terminated due to lack of enrollment that has been compounded by the global COVID-19 pandemic. There were no safety and/or efficacy concerns involved in the decision to stop enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Disease ProgressionStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436120
- Sponsor's protocol ID
- A9001502
- Other IDs
- TRANSLATE, 2018-003612-45, 2018
- Status last verified
- Nov 2024
- First submitted
- 9 Jun 2020
- Last updated
- 3 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TREATMENT RESISTANCE FOLLOWING ANTI-CANCER THERAPIES (TRANSLATE)
- ClinicalTrials.gov ID
- NCT04436120
- Acronym / sponsor ID
- A9001502
- Conditions
- Disease Progression
- Keywords
- Non Small Cell Lung Cancer, Renal Cell Carcinoma, HR+ HER2- Breast Cancer, Castrate-Resistant Prostate Cancer, Germline mutated BRCA, HER2- Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to lack of enrollment that has been compounded by the global COVID-19 pandemic. There were no safety and/or efficacy concerns involved in the decision to stop enrollment.
- Enrolment
- 38 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 17 Jun 2020 (actual)
- Results
- Posted 3 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumor biopsy and blood draw | Other | Procedure: De novo tumor tissue biopsy, Procedure: Research blood drawsTumor biopsy and blood draw |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| De novo tumor tissue biopsyDe novo tissue biopsy performed following disease progression | Procedure or surgery | Tumor biopsy and blood draw |
| Research blood drawsBlood biospecimens collected following disease progression | Procedure or surgery | Tumor biopsy and blood draw |
Primary outcome
Change in the Frequency of Gene Alterations Between Pre-treatment Tumor Samples (Archival) and Post-progression (De Novo) Tumor Biopsies
Time frame: Through study completion, approximately 3 months
Change in frequency is calculated by (frequency in de novo samples) - (frequency in archival samples). The frequency of each gene alteration is calculated as number of patients who harbored the alteration divided by the total number of patients in the cohort. Only gene alterations with variant allele frequency of 5% or greater were included in the analysis. Two different sequencing techniques were applied so 2 analysis sets were repeated for each cohort: targeted panel next-generation sequencing (NGS) and whole exome sequencing NGS.
7 secondary outcomes
Number of Participants With Fully Evaluable Archival and Post-Progression Tumor Biopsy by Cohort
Time frame: Through study completion, approximately 3 months
Overall Agreement Rate of Gene Alterations Between Post-Progression Tumor Biopsy and Blood NGS Results
Time frame: Through study completion, approximately 3 months
Change in Frequency of RB1 Gene Alterations Between Pre-Treatment Archival and Post-Progression Samples
Time frame: Through study completion, approximately 3 months
Percentage of Participants Who Carried the RB1 Gene Alterations in Post-Progression Blood cfDNA
Time frame: Through study completion, approximately 3 months
Change in Frequency of AR Gene Alterations Between Pre-Treatment Archival and Post-Progression Samples
Time frame: Through study completion, approximately 3 months
Percentage of Participants Who Carried the AR Gene Alterations in Post-Progression Blood cfDNA
Time frame: Through study completion, approximately 3 months
Change in Expression of Nuclear Hormone Receptors Between Pre-Treatment Archival and Post-Progression Samples
Time frame: Through study completion, approximately 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
33 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing De novo tumor tissue biopsy and Research blood draws in people with Disease Progression, run by Pfizer at 33 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, France, Belgium, Argentina, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Frequency of Gene Alterations Between Pre-treatment Tumor Samples (Archival) and Post-progression (De Novo) Tumor Biopsies (time frame: Through study completion, approximately 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.