Advanced CancersNCT02508662
Registry Study for Personalized Cancer Therapy
An observational study of Advanced Cancers and Solid Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Objectives: Primary Objectives: To evaluate the anti-cancer activity of commercially available, targeted anti-cancer therapies used off-label for treatment in patients with advanced solid cancer with known genomic aberrations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers, Solid Tumors
- What is being tested?
- Review of Screening Tests and Molecular Test Results
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2015to 10 Jul 2020
- 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: Participants with advanced solid cancer with known genomic aberrations at MD Anderson Cancer Center.
Who may be able to join
- Patients with advanced or metastatic cancer that is refractory to standard therapy or that has relapsed after standard therapy or has no standard therapy that increases survival by at least three months.
- Patients with a potentially actionable genomic alteration.
- All prior treatment-related toxicities must be resolved to CTCAE (Version 4.0) < or = Grade 2 (except alopecia) at the time of screening.
- Patients willing to sign informed consent.
- Patients under the age of 18 years old are allowed as long as the safety profile of the drug is established in the pediatric population.
Who cannot join
- Any serious and/or unstable pre-existing medical disorder, psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator.
- Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to planned treatment drug.
- Rapidly progressing leptomeningeal or brain metastases or spinal cord compression.
- Clinical trial (including targeted and/or non-targeted) other than registry study is available; patient is willing and eligible to enroll in such trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Objectives:
Primary Objectives:
Read more
To evaluate the anti-cancer activity of commercially available, targeted anti-cancer therapies used off-label for treatment in patients with advanced solid cancer with known genomic aberrations.
Secondary Objectives:
To determine outcomes of patients who were treated with matched targeted anti-cancer therapies based on known genomic aberrations.
To obtain treatment related adverse events in patients with advanced solid tumor who were treated with off -label targeted therapies.
To determine co-genomic aberrations that may contribute to treatment response or resistance mechanisms.
To determine feasibility of detecting the genomic alterations in plasma, and the genomic evolution of circulating biomarkers.
Read the detailed description
Study Treatment Assignment:
If you are found to be eligible to take part in this study, the study doctor will review the test results in your medical records that were previously performed as part of your routine care. The results of the testing may be helpful in managing your treatment and may also help the doctor to find effective off-label use of FDA approved therapies for the type of cancer you have.
After reviewing the screening tests and the molecular test results in your medical records, the study staff and your study doctor will work together to find an off-label use for an FDA approved therapy that is best for you. You may receive a single therapy or a combination of therapies. You and the study doctor will discuss this.
The study doctor or study staff will tell you which drug(s) you will be taking, the dose of the study drug(s), and how often you should take them. You will sign a separate consent form that explains in more detail how the study drug(s) are administered and the potential benefits and side effects of taking the study drug(s).
Study Visits:
While you are receiving treatment and during follow-up, you will have your routine, standard of care clinic visits and routine tests so that the doctor may check the status of the disease to learn if the therapy chosen to treat the disease is having any effect. Information from these routine visits will be collected and stored by the study staff. The timing of these visits will depend on the type of therapy you receive.
During every cycle of therapy (about every 3-4 weeks):
- You will have a physical exam.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- If your doctor thinks it is needed, urine will be collected for routine tests.
- If your doctor thinks it is needed, you will have an EKG to check the health of your heart.
After even numbered cycles (2, 4, 6, and so on), or more often if the doctor thinks is it needed, you will have the same imaging scan(s) which were done during Screening to check the status of the disease.
This is an investigational study.
Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.
- Conditions
- Advanced Cancers, Solid Tumors
- Being tested
- Review of Screening Tests and Molecular Test Results
- Keywords
- Advanced Cancers, Solid Tumors, Genomic Mutations, FDA Approved Off-Label Chemotherapy, Refractory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Review of Screening Tests and Molecular Test ResultsOther
Review of screening tests and molecular test results in participant's medical records. Study staff and study doctor work together to find an off-label use for an FDA approved therapy that is best for participant.
| Study group | Role | What they receive |
|---|---|---|
| Advanced Cancer (Refractory) with Genomic Mutation | Participants with advanced cancer who have exhausted standard treatment option and have no potential clinical trial available, and who have potentially actionable alterations on genomic profiling. Receives: Other: Review of Screening Tests and Molecular Test Results |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Response
Evaluation of tumor: the same imaging technique used during the initial evaluation or more sophisticated studies performed once after 2 cycles.
Patients with measurable disease assessed by standard RECIST (Version 1.1).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study start21 Jul 2015
- Primary completion10 Jul 2020
- Study completion10 Jul 2020
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Funda Meric-Bernstam, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508662
- Sponsor's protocol ID
- 2015-0300
- Other IDs
- NCI-2015-01453
- Status last verified
- Jul 2020
- First submitted
- 22 Jul 2015
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Study for Personalized Cancer Therapy
- ClinicalTrials.gov ID
- NCT02508662
- Acronym / sponsor ID
- 2015-0300
- Conditions
- Advanced Cancers, Solid Tumors
- Keywords
- Advanced Cancers, Solid Tumors, Genomic Mutations, FDA Approved Off-Label Chemotherapy, Refractory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 21 Jul 2015 (actual)
- Primary completion
- 10 Jul 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 27 Jul 2015 (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.
Objectives:
Primary Objectives:
To evaluate the anti-cancer activity of commercially available, targeted anti-cancer therapies used off-label for treatment in patients with advanced solid cancer with known genomic aberrations.
Secondary Objectives:
To determine outcomes of patients who were treated with matched targeted anti-cancer therapies based on known genomic aberrations.
To obtain treatment related adverse events in patients with advanced solid tumor who were treated with off -label targeted therapies.
To determine co-genomic aberrations that may contribute to treatment response or resistance mechanisms.
To determine feasibility of detecting the genomic alterations in plasma, and the genomic evolution of circulating biomarkers.
Detailed description
Study Treatment Assignment:
If you are found to be eligible to take part in this study, the study doctor will review the test results in your medical records that were previously performed as part of your routine care. The results of the testing may be helpful in managing your treatment and may also help the doctor to find effective off-label use of FDA approved therapies for the type of cancer you have.
After reviewing the screening tests and the molecular test results in your medical records, the study staff and your study doctor will work together to find an off-label use for an FDA approved therapy that is best for you. You may receive a single therapy or a combination of therapies. You and the study doctor will discuss this.
The study doctor or study staff will tell you which drug(s) you will be taking, the dose of the study drug(s), and how often you should take them. You will sign a separate consent form that explains in more detail how the study drug(s) are administered and the potential benefits and side effects of taking the study drug(s).
Study Visits:
While you are receiving treatment and during follow-up, you will have your routine, standard of care clinic visits and routine tests so that the doctor may check the status of the disease to learn if the therapy chosen to treat the disease is having any effect. Information from these routine visits will be collected and stored by the study staff. The timing of these visits will depend on the type of therapy you receive.
During every cycle of therapy (about every 3-4 weeks):
- You will have a physical exam.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- If your doctor thinks it is needed, urine will be collected for routine tests.
- If your doctor thinks it is needed, you will have an EKG to check the health of your heart.
After even numbered cycles (2, 4, 6, and so on), or more often if the doctor thinks is it needed, you will have the same imaging scan(s) which were done during Screening to check the status of the disease.
This is an investigational study.
Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced Cancer (Refractory) with Genomic Mutation | – | Other: Review of Screening Tests and Molecular Test ResultsParticipants with advanced cancer who have exhausted standard treatment option and have no potential clinical trial available, and who have potentially actionable alterations on genomic profiling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with advanced solid cancer with known genomic aberrations at MD Anderson Cancer Center.
Key inclusion criteria (5 listed)
- Patients with advanced or metastatic cancer that is refractory to standard therapy or that has relapsed after standard therapy or has no standard therapy that increases survival by at least three months.
- Patients with a potentially actionable genomic alteration.
- All prior treatment-related toxicities must be resolved to CTCAE (Version 4.0) < or = Grade 2 (except alopecia) at the time of screening.
- Patients willing to sign informed consent.
- Patients under the age of 18 years old are allowed as long as the safety profile of the drug is established in the pediatric population.
Key exclusion criteria (4 listed)
- Any serious and/or unstable pre-existing medical disorder, psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator.
- Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to planned treatment drug.
- Rapidly progressing leptomeningeal or brain metastases or spinal cord compression.
- Clinical trial (including targeted and/or non-targeted) other than registry study is available; patient is willing and eligible to enroll in such trial.
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 |
|---|---|---|
| Review of Screening Tests and Molecular Test ResultsReview of screening tests and molecular test results in participant's medical records. Study staff and study doctor work together to find an off-label use for an FDA approved therapy that is best for participant. | Other | Advanced Cancer (Refractory) with Genomic Mutation |
Primary outcome
Tumor Response
Time frame: 8 weeks
Evaluation of tumor: the same imaging technique used during the initial evaluation or more sophisticated studies performed once after 2 cycles. Patients with measurable disease assessed by standard RECIST (Version 1.1).
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 14 Jul 2020.
- 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.
Funda Meric-Bernstam, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Cancers and Solid Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
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 5 inclusion and 4 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 14 Jul 2020. 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 United States. 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?
Tumor Response (time frame: 8 weeks). 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 14 Jul 2020.