Metastatic CancerWINTHERNCT01856296
A Study to Select Rational Therapeutics Based on the Analysis of Matched Tumor and Normal Biopsies in Subjects With Advanced Malignancies
A study testing Biopsy in people with Metastatic Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
An open non-randomized study using biology driven selection of therapies. WINTHER study will explore matched tumoral and normal tissue biopsies and will use a novel method for predicting efficacy of drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 1 siteFrance
- Study dates
- 23 Apr 2013to 22 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Informed consent
- Any histologic type of metastatic cancer, (except for lung and brain at US sites), in which histologic normal counterpart can be obtained.
- Progression by RECIST (Response Evaluation Criteria In Solid Tumors) or other criteria on at least one prior regimen for advanced disease.
- Ability to undergo a biopsy or surgical procedure to obtain fresh tumor biopsy paired with its normal counterpart.
- Age from 18 years
- Life expectancy of at least 3 months
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- ECOG Performance status of 0 to 1
- Measurable or evaluable disease according to RECIST 1.1 criteria
- For U.S. sites, advanced cancer patients that have exhausted all effective therapy for their disease and have progressed after previous line of therapy (documented disease progression under last treatment received) and conventional methods of assigning new therapy would not be expected to increase survival by more than 3 months.
Who cannot join
- Any patient that might require a lung or brain biopsy are excluded (at US sites)
- Alteration of organ function or hematopoietic function as defined by the following criteria:
- Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) >2.5 x upper limit of normal (ULN), except for patients with liver metastases, for which AST and ALT > 5.0 ULN is the exclusion criteria.
- Bilirubin > 2.0 ULN
- Polynuclear neutrophil < 1.5 x 109/L
- Platelets < 100 x 10 9/L
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- Hemoglobin < 90 g/L
- Creatinine > 1.5 ULN
- Calcemia > 1.5 ULN
- Phosphatemia > 1.5 ULN
- Coagulation abnormality prohibiting a biopsy
- Symptomatic or progressive brain metastases detected by radio imaging, or meningeal
- Patient who received a personalized therapeutic treatment based on molecular anomaly during the treatment period prior to the WINTHER directed treatment (defining the PFS1). Hormonal therapy may be continued during WINTHER suggested therapy. The exclusion of prior matched targeted therapy includes but is not limited to all targeted therapeutics that are EMA approved and genomically matched to patients. If there are questions about whether or not a prior therapy is matched targeted treatment it will be agreed on by discussion between PIs who are also Clinical Management Committee members; the resolution should take place prior to starting WINTHER directed treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: WINTHER: A Study to Select Rational Therapeutics Based on the Analysis of Matched Tumor and Normal Biopsies in Subjects With Advanced Malignancies
An open non-randomized study using biology driven selection of therapies. WINTHER study will explore matched tumoral and normal tissue biopsies and will use a novel method for predicting efficacy of drugs. The aim is to provide a rational personalized therapeutic choice to all (100 %) patients enrolled in the study, harboring oncogenic events (mutations/ translocations/ amplifications, etc.) or not. The total number of patients treated in the study will be two hundred across all participating cancer centers (European countries -France; Spain-, Israel, USA and Canada). All centers will realize the same study independently.
- Conditions
- Metastatic Cancer
- Being tested
- Biopsy
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | ARM A patients with an identified oncogenic driver mutations/amplifications/translocations), who will potentially benefit from targeted therapies, either on the market or in clinical trials according to existing knowledge of matching oncogenic events with actionable drugs. This will be detected through Next Generation Sequencing (NGS) performed by Foundation Medicine, CLIA certified. Receives: Procedure: Biopsy |
| Arm B | Experimental | patients negative for oncogene events (which remains the majority), for whom genome based relevant information will be obtained through functional genomics (micro arrays and gene expression profiling) performed by Institut Gustave Roussy, and innovative computational methods enabling a rational choice of therapies. For such patients we will apply a new prediction model of efficacy of existing and under clinical trial drugs, based on differences in gene expression profiling between tumor and normal biopsies to be matched with relevant genes that are related to drug activities. Receives: Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
To assess the individual outcome of patients with advanced malignancies, by comparing the progression-free survival (PFS) using a treatment regimen selected by a molecular analysis of a patient's tumor with the PFS for the most recent regimen on which the patient had experienced progression
- ARM A : PFS2/PFS1 >1.5 in 50% of patients
- ARM B : PFS2/PFS1 >1.5 in 40% of patients
The primary endpoint of the study is the ratio of the PFS of the current treatment (PFS2) versus the previous treatment (PFS1). Because patients will be enrolled in the study while they are still on treatment (before progression), we expect that PFS for the previous treatment is fully observed. If patients withdrew from the treatment due to treatment related toxicity and lost to follow-up, it is considered that the PFS endpoint is reached. If patients are lost to follow up due to other reasons, PFS is censored at the time of last follow up.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study start23 Apr 2013
- Primary completion7 Dec 2015
- Study completion22 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856296
- Sponsor's protocol ID
- 2012-A01738-35
- Other IDs
- 2012/1946
- Acronym
- WINTHER
- Status last verified
- Aug 2026
- First submitted
- 15 May 2013
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Rodon J, Soria JC, Berger R, Miller WH, Rubin E, Kugel A, Tsimberidou A, Saintigny P, Ackerstein A, Brana I, Loriot Y, Afshar M, Miller V, Wunder F, Bresson C, Martini JF, Raynaud J, Mendelsohn J, Batist G, Onn A, Tabernero J, Schilsky RL, Lazar V, Lee JJ, Kurzrock R. Genomic and transcriptomic profiling expands precision cancer medicine: the WINTHER trial. Nat Med. 2019 May;25(5):751-758. doi: 10.1038/s41591-019-0424-4. Epub 2019 Apr 22.
PubMed 31011205
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WINTHER: A Study to Select Rational Therapeutics Based on the Analysis of Matched Tumor and Normal Biopsies in Subjects With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT01856296
- Acronym / sponsor ID
- WINTHER / 2012-A01738-35
- Conditions
- Metastatic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 23 Apr 2013 (actual)
- Primary completion
- 7 Dec 2015 (actual)
- Study completion
- 22 Feb 2019 (actual)
- First posted
- 17 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open non-randomized study using biology driven selection of therapies. WINTHER study will explore matched tumoral and normal tissue biopsies and will use a novel method for predicting efficacy of drugs. The aim is to provide a rational personalized therapeutic choice to all (100 %) patients enrolled in the study, harboring oncogenic events (mutations/ translocations/ amplifications, etc.) or not. The total number of patients treated in the study will be two hundred across all participating cancer centers (European countries -France; Spain-, Israel, USA and Canada). All centers will realize the same study independently.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Procedure: BiopsyARM A patients with an identified oncogenic driver mutations/amplifications/translocations), who will potentially benefit from targeted therapies, either on the market or in clinical trials according to existing knowledge of matching oncogenic events with actionable drugs. This will be detected through Next Generation Sequencing (NGS) performed by Foundation Medicine, CLIA certified. |
| Arm B | Experimental | Procedure: Biopsypatients negative for oncogene events (which remains the majority), for whom genome based relevant information will be obtained through functional genomics (micro arrays and gene expression profiling) performed by Institut Gustave Roussy, and innovative computational methods enabling a rational choice of therapies. For such patients we will apply a new prediction model of efficacy of existing and under clinical trial drugs, based on differences in gene expression profiling between tumor and normal biopsies to be matched with relevant genes that are related to drug activities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Informed consent
- Any histologic type of metastatic cancer, (except for lung and brain at US sites), in which histologic normal counterpart can be obtained.
- Progression by RECIST (Response Evaluation Criteria In Solid Tumors) or other criteria on at least one prior regimen for advanced disease.
- Ability to undergo a biopsy or surgical procedure to obtain fresh tumor biopsy paired with its normal counterpart.
- Age from 18 years
Key exclusion criteria (13 listed)
- Any patient that might require a lung or brain biopsy are excluded (at US sites)
- Alteration of organ function or hematopoietic function as defined by the following criteria:
- Coagulation abnormality prohibiting a biopsy
- Symptomatic or progressive brain metastases detected by radio imaging, or meningeal
- Patient who received a personalized therapeutic treatment based on molecular anomaly during the treatment period prior to the WINTHER directed treatment (defining the PFS1). Hormonal therapy may be continued during WINTHER suggested therapy. The exclusion of prior matched targeted therapy includes but is not limited to all targeted therapeutics that are EMA approved and genomically matched to patients. If there are questions about whether or not a prior therapy is matched targeted treatment it will be agreed on by discussion between PIs who are also Clinical Management Committee members; the resolution should take place prior to starting WINTHER directed treatment.
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 |
|---|---|---|
| Biopsy | Procedure or surgery | Arm A, Arm B |
Primary outcome
Progression Free Survival
Time frame: Up to 6 months
To assess the individual outcome of patients with advanced malignancies, by comparing the progression-free survival (PFS) using a treatment regimen selected by a molecular analysis of a patient's tumor with the PFS for the most recent regimen on which the patient had experienced progression * ARM A : PFS2/PFS1 >1.5 in 50% of patients * ARM B : PFS2/PFS1 >1.5 in 40% of patients The primary endpoint of the study is the ratio of the PFS of the current treatment (PFS2) versus the previous treatment (PFS1). Because patients will be enrolled in the study while they are still on treatment (before progression), we expect that PFS for the previous treatment is fully observed. If patients withdrew from the treatment due to treatment related toxicity and lost to follow-up, it is considered that the PFS endpoint is reached. If patients are lost to follow up due to other reasons, PFS is censored at the time of last follow up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Results publication: PubMed 31011205Rodon J, Soria JC, Berger R, Miller WH, Rubin E, Kugel A, Tsimberidou A, Saintigny P, Ackerstein A, Brana I, Loriot Y, Afshar M, Miller V, Wunder F, Bresson C, Martini JF, Raynaud J, Mendelsohn J, Batist G, Onn A, Tabernero J, Schilsky RL, Lazar V, Lee JJ, Kurzrock R. Genomic and transcriptomic profiling expands precision cancer medicine: the WINTHER trial. Nat Med. 2019 May;25(5):751-758. doi: 10.1038/s41591-019-0424-4. Epub 2019 Apr 22.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy in people with Metastatic Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
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 13 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: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progression Free Survival (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01856296, which also lists 1 linked publication.
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 11 Aug 2026.