ASCO launches first study with molecular targeted agents
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The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is now open for enrollment in select centers. Patients enrolled in the study will have access to these cancer agents at no cost.
http://www.asco.org/practice-research/targeted-agent-and-profiling-utilization-registry-study
For overview of study and Eligibility Criteria, DISCUSS WITH YOUR PHYSICIAN OR CONTACT ASCO DIRECTLY;
Use below link:
http://www.tapur.org/patientsThis link provides information for frequently asked questions :
http://www.tapur.org/node/31TAPUR will launch in the first quarter of 2016 at four cancer center networks: the Carolinas HealthCare System’s Levine Cancer Institute, the Cancer Research Consortium of West Michigan, the Michigan Cancer Research Consortium, and the University of Michigan with plans for expansion in late 2016.
More detailed information can be found here:
https://clinicaltrials.gov/ct2/show/NCT02693535Good luck and please keep us posted.
A brief update:
What differentiates the TAPUR study from that of the NCI MATCH study?Answer: tissue sample.
TAPUR accepts previously collected biopsy analysed by a certified lab
MATCH requires a fresh biopsy2nd noticeable difference:
MATCH is coordinating treatments with physicians in community centers affiliated with research programs. Please see map:
http://ncorp.cancer.gov/findasite/map.htmlTAPUR – regardless of physician’s location or affiliation – can request study participation for their patients
ASCO will collaborate and share data with the Netherlands Center for Personalized Cancer Treatment, which is conducting a clinical trial using a very similar study protocol.TAPUR study is expected to launch January or February 2016
MATCH has similar date.
Both studies require: patients must have failed standard of care.Still to investigate: Is Gemcitabine/Cisplatin “standard of care” of is it “preferred care”?
If so, then I would assume that patients can have failed on Gemcitabine or Gemzar (single agents) only and still qualify for this trial. I will look into this.Both, mutations and targeted drugs will continue to develop.
Please discuss with physician.
MarionIn regards to genetic testing conducted prior to submitting request for inclusion of this trial, I received the following response from ASCO’s research coordinator:
” TAPUR will involve using of therapies that have been approved by the FDA to target genomic variants. The protocol requires test results to demonstrate that a genomic variant known to be a drug target or to predict sensitivity to a drug is present in the patient’s cancer. The choice of test is up to the physician and patient, so long as test is done in a lab that has CLIA certification, CAP accreditation, and certification from the state of NY (for labs offering services in NY).
Currently, the testing is done outside of the protocol and is not provided as part of the study. ASCO is strategizing how to make the testing available for patients. We are engaging in discussions with patient advocacy groups who offer testing and programs for patient assistance and exploring ways to make TAPUR an feasible option.”
Hugs,
MarionThe ASCO TAPUR clinical trial initially will be launched – hopefully by end of year – at Michigan Cancer Research Consortium, the Cancer Research Consortium of West Michigan, and the Carolinas Healthcare System—existing research networks that run research trials for the National Cancer Institute and industry—with the ultimate goal of expanding nationally.
The majority of CC patients have identifiable genomic aberrations but they don’t have access to specific drugs because; efficacy has not been tested in our patient group or a clinical trial does not include a Cholangiocarcinoma patient cohort. Although; once approved for other cancers, physicians are allowed to prescribe these drugs off-label, due to lack of supportive data, they are reluctant or unwilling to do so .
The TAPUR clinical research study enables physicians to enroll his/her patient and the drugs are provided free of charge. It is assumed that additional cost will be covered by participant’s insurance provider.Unlike the NCI MATCH study, which requires tumor biopsy for enrollment, it appears that the TAPUR study accepts molecular tumor analyses obtained by the patient. I am investigating this issue.
Prospective participants must have an advanced solid tumor, multiple myeloma or non-Hodgkin lymphoma with a genomic variation that can be targeted with a commercially available study drug.
Patients must no longer be benefiting from standard treatment and must be healthy enough to participate.
To read up more, use the below link:
http://www.asco.org/practice-research/targeted-agent-and-profiling-utilization-registry-studyEUROPEAN PATIENTS:
ASCO will collaborate and share data with the Netherlands Center for Personalized Cancer Treatment, which is conducting a clinical trial using a very similar study protocol.
Please use this link:
http://www.nki.nl/
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