Advanced CancersNCT02272595
Rational Therapeutics Based on Matched Tumor and Normal Tissue
An observational study of Advanced Cancers, run by M.D. Anderson Cancer Center at 4 sites in 4 countries.
Trial summary
The goal of this laboratory research study is to learn if using molecular information (matched therapy) or not using molecular information and having the study doctor choose the therapy based on your past experience are more effective ways to choose the best cancer treatment for you. This is an investigational study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- Treatment Based on Genetic Mutation and Treatment Based on No Genetic Mutation
- How many people
- 3 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 4 Nov 2014to 11 Jan 2022
- Phase
- Observational
- 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
Study population: Cancer patients from University of Texas MD Anderson Cancer Center in Houston, Texas, Cancer Institute Gustave Roussy in Villejuif, France, Vall D'Hebron University Hospital in Barcelona, Spain, and Chaim Sheba Medical Center at Tel Hasomer in Ramat Gan, Israel
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. See list of cancer types included in the trial in Appendix 1.
- 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 US sites only: 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
- For US sites only: Any patient that might require a lung or brain biopsy are excluded
- 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 to allow for Gilberts
- 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 g. 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 immediately 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 a 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
4 sites in 4 countries.
4 sites in 4 countries
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Study to Select Rational Therapeutics Based on the Analysis of Matched Tumor and Normal Biopsies in Subjects With Advanced Malignancies
The goal of this laboratory research study is to learn if using molecular information (matched therapy) or not using molecular information and having the study doctor choose the therapy based on your past experience are more effective ways to choose the best cancer treatment for you.
This is an investigational study.
Up to 200 participants will take part in this study. Up to 50 will be enrolled at MD Anderson.
Read the detailed description
If you agree to take part in this study, your tumor tissue and blood samples will be tested for molecular profiling. Molecular profiling is the classification of tissue based on the expression of certain genes within a tumor compared to normal tissue. This may be used to predict how the tumor responds to therapy. Your doctor may use the results of the molecular profiling to help decide which treatment might be the most beneficial for the disease.
Study Procedures:
Blood (about 2 teaspoons) will be drawn and you will have a tumor biopsy and a biopsy of normal tissue when you enroll in this study. Blood (about 2 teaspoons) will be drawn again about 2-3 weeks after you begin treatment. The type of biopsy you have will depend on the type of disease you have. The risks of this procedure will be discussed in more detail with you.
If there is not enough tissue with which the study doctor can perform the study tests (described below), you may need to have a second biopsy. The study staff will discuss this with you if it is needed.
Treatment Arms:
A series of tests to find which gene mutations you have, if any, will be performed. Depending on the results of your molecular testing, you may be enrolled on 1 of 2 arms.
If your molecular profile shows that you have a gene mutation that may benefit from study drugs that are believed to target your gene mutation, you will be enrolled in Arm A and will receive these targeted drugs.
If your molecular profile shows that you do not have a gene mutation, you will be enrolled in Arm B. In Arm B, the doctor will choose a therapy based on other studies rather than gene mutation.
Length of Study:
This study will last about 2 years. Your participation on this study will be complete after the last blood draw and tumor biopsy is collected.
- Conditions
- Advanced Cancers
- Being tested
- Treatment Based on Genetic Mutation, Treatment Based on No Genetic Mutation
- Keywords
- Biologic Markers, Molecular testing, Advanced cancers, Molecular information, Molecular profiling, Genetic Mutation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment Based on Genetic MutationOther
Participant's molecular profile shows that they have a gene mutation that may benefit from study drugs that are believed to target their gene mutation. Participant assigned to Arm A and will receive these targeted drugs.
Treatment Based on No Genetic MutationOther
Participant's molecular profile shows that they do not have a gene mutation. Participant assigned to Arm B in which doctor chooses a therapy based on other studies rather than gene mutation.
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Treatment Based on Genetic Mutation | Participant's molecular profile shows that they have a gene mutation that may benefit from study drugs that are believed to target their gene mutation. Participant assigned to Arm A and will receive these targeted drugs. Receives: Other: Treatment Based on Genetic Mutation | |
| Arm B - Treatment Based on No Genetic Mutation | Participant's molecular profile shows that they do not have a gene mutation. Participant assigned to Arm B in which doctor chooses a therapy based on other studies rather than gene mutation. Receives: Other: Treatment Based on No Genetic Mutation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Progression-free survival (PFS) of the last therapeutic line (PFS1) before entering into study, with the PFS2 under study treatment. A clinical meaningful improvement is defined as demonstrating a PFS ratio (PFS2/PFS1) of being 1.5 or better.
Measured: 2 - 3 weeks after treatment begins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study start4 Nov 2014
- Primary completion11 Jan 2022
- Study completion11 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Sponsor
- Investigators
- Apostolia M. Tsimberidou, MD, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272595
- Sponsor's protocol ID
- PA12-0381
- Status last verified
- Feb 2022
- First submitted
- 20 Oct 2014
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Select Rational Therapeutics Based on the Analysis of Matched Tumor and Normal Biopsies in Subjects With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT02272595
- Acronym / sponsor ID
- PA12-0381
- Conditions
- Advanced Cancers
- Keywords
- Biologic Markers, Molecular testing, Advanced cancers, Molecular information, Molecular profiling, Genetic Mutation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- 4 Nov 2014 (actual)
- Primary completion
- 11 Jan 2022 (actual)
- Study completion
- 11 Jan 2022 (actual)
- First posted
- 23 Oct 2014 (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.
The goal of this laboratory research study is to learn if using molecular information (matched therapy) or not using molecular information and having the study doctor choose the therapy based on your past experience are more effective ways to choose the best cancer treatment for you.
This is an investigational study.
Up to 200 participants will take part in this study. Up to 50 will be enrolled at MD Anderson.
Detailed description
If you agree to take part in this study, your tumor tissue and blood samples will be tested for molecular profiling. Molecular profiling is the classification of tissue based on the expression of certain genes within a tumor compared to normal tissue. This may be used to predict how the tumor responds to therapy. Your doctor may use the results of the molecular profiling to help decide which treatment might be the most beneficial for the disease.
Study Procedures:
Blood (about 2 teaspoons) will be drawn and you will have a tumor biopsy and a biopsy of normal tissue when you enroll in this study. Blood (about 2 teaspoons) will be drawn again about 2-3 weeks after you begin treatment. The type of biopsy you have will depend on the type of disease you have. The risks of this procedure will be discussed in more detail with you.
If there is not enough tissue with which the study doctor can perform the study tests (described below), you may need to have a second biopsy. The study staff will discuss this with you if it is needed.
Treatment Arms:
A series of tests to find which gene mutations you have, if any, will be performed. Depending on the results of your molecular testing, you may be enrolled on 1 of 2 arms.
If your molecular profile shows that you have a gene mutation that may benefit from study drugs that are believed to target your gene mutation, you will be enrolled in Arm A and will receive these targeted drugs.
If your molecular profile shows that you do not have a gene mutation, you will be enrolled in Arm B. In Arm B, the doctor will choose a therapy based on other studies rather than gene mutation.
Length of Study:
This study will last about 2 years. Your participation on this study will be complete after the last blood draw and tumor biopsy is collected.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A - Treatment Based on Genetic Mutation | – | Other: Treatment Based on Genetic MutationParticipant's molecular profile shows that they have a gene mutation that may benefit from study drugs that are believed to target their gene mutation. Participant assigned to Arm A and will receive these targeted drugs. |
| Arm B - Treatment Based on No Genetic Mutation | – | Other: Treatment Based on No Genetic MutationParticipant's molecular profile shows that they do not have a gene mutation. Participant assigned to Arm B in which doctor chooses a therapy based on other studies rather than gene mutation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients from University of Texas MD Anderson Cancer Center in Houston, Texas, Cancer Institute Gustave Roussy in Villejuif, France, Vall D'Hebron University Hospital in Barcelona, Spain, and Chaim Sheba Medical Center at Tel Hasomer in Ramat Gan, Israel
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. See list of cancer types included in the trial in Appendix 1.
- 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 (12 listed)
- For US sites only: Any patient that might require a lung or brain biopsy are excluded
- 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 immediately 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 a 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 |
|---|---|---|
| Treatment Based on Genetic MutationParticipant's molecular profile shows that they have a gene mutation that may benefit from study drugs that are believed to target their gene mutation. Participant assigned to Arm A and will receive these targeted drugs. | Other | Arm A - Treatment Based on Genetic Mutation |
| Treatment Based on No Genetic MutationParticipant's molecular profile shows that they do not have a gene mutation. Participant assigned to Arm B in which doctor chooses a therapy based on other studies rather than gene mutation. | Other | Arm B - Treatment Based on No Genetic Mutation |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 2 - 3 weeks after treatment begins
Progression-free survival (PFS) of the last therapeutic line (PFS1) before entering into study, with the PFS2 under study treatment. A clinical meaningful improvement is defined as demonstrating a PFS ratio (PFS2/PFS1) of being 1.5 or better.
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 15 Feb 2022.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Apostolia M. Tsimberidou, MD, PHD principal investigator
M.D. Anderson Cancer Center
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Cancers, run by M.D. Anderson Cancer Center at 4 sites in 4 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 12 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 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, France, Israel, Spain. 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 (PFS) (time frame: 2 - 3 weeks after treatment begins). 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 15 Feb 2022.