New Clinical Trial For Patients No Longer Benefitting from Standard Therapy, or For Whom No Standard Therapy is Available

Posted by Dr. Guneet Walia on March 23rd, 2016

This Monday, the American Society of Clinical Oncology (ASCO) launched its first ever clinical trial that has been designed with a unique format and allows patients with advanced solid tumor (including lung cancer), multiple myeloma, or B cell non-Hodgkin lymphoma who are no longer benefitting from standard anti-cancer treatments, or for whom no acceptable standard treatment is available, to participate.

Patients enrolled in this trial will receive treatment at no cost.

This trial, named TAPUR or Targeted Agent and Profiling Utilization Registry, will evaluate molecularly targeted therapies and collect data on clinical outcomes to learn additional uses of drugs that have already been approved by the FDA for other indications. TAPUR is a multi-arm, Phase 2, basket study.

Trial Design: TAPUR will enroll participants whose tumor has at least one genomic variant that is potentially targeted by one or more drugs available in the study. Physicians will select from a set of drugs that is defined in the study protocol or, if necessary, can consult a Molecular Tumor Board for information about possible treatment options.

For each specific combination of tumor type, genetic variant and study drug, 10 participants will initially be enrolled. In groups where at least two participants respond to therapy, enrollment will expand by an additional 18 participants, for a total of 28. Participants will be followed for standard toxicity and efficacy outcomes, and data on anti-tumor activity and toxicities will be collected for analysis and reviewed by an independent Data and Safety Monitoring Board. If a total of at least seven responses are seen in a particular group of 28 patients, the trial investigators will propose that the drug under investigation has a signal of activity and should be followed up with additional studies to confirm activity in that particular tumor type.

The currently planned arms of the trial include the following:

Arms

Actionable Genomic Alteration

Targeted Therapy

Group 1

VEGFR

Axitinib (Inlyta)

Group 2

BCR-ABL, SRC, LYN, LCK

Bosutinib (Bosulif)

Group 3

ALK, ROS1, MET

Crizotinib (Xalkori)

Group 4

CDKN2A/p16, CDK4, CDK6

Palbociclib (Ibrance)

Group 5

CSF1R, PDGFR, VEGFR

Sunitinib (Sutent)

Group 6

mTOR, TSC

Temsirolimus (Torisel)

Group 7

EGFR

Erlotinib (Tarceva)

Group 8

ERBB2

Trastuzumab (Herceptin) and Pertuzumab (Perjeta)

Group 9

BRAFV600E

Vemurafenib (Zelboraf) and Cobimetinib (Cotellic)

Group 10

PTCH1

Vismodegib (Erivedge)

Group 11

KRAS, NRAS, BRAF

Cetuximab (Erbitux)

Group 12

BCR-ABL, SRC, KIT, PDGFRB, EPHA2, FYN, LCK, YES1

Dasatinib (Sprycel)

Trial Management: ASCO will manage all aspects of the study. In addition to the Molecular Tumor Board and Data and Safety Monitoring Board, ASCO has established a Steering Group to oversee the trial. Patients and patient advocates are included in each of these groups and play a central role in providing direction and guidance regarding all aspects of the study. An Institutional Review Board has approved the study.

Pharma partners: Bristol-Myers Squibb, Eli Lilly and Company, Genentech and Pfizer have committed to provide marketed, targeted drugs at no cost to participants, as well as additional resources to support the TAPUR study. Additional companies are planning to participate after the study launch.

ASCO will use the Syapse Precision Medicine Platform to automate the study workflow including patient registration, eligibility assessment, matching of patients to therapies based on genomic data, drug ordering, data collection, and facilitating the Molecular Tumor Board process. Study drugs will be dispensed through Cardinal Health Specialty Pharmacy, and will be procured through direct integration with the Syapse TAPUR platform. Illumina’s NextBio Clinical and KnowledgeBase will support and inform case review by the Molecular Tumor Board.

ASCO will also collaborate with the Netherlands Center for Personalized Cancer Treatment, which is conducting a clinical trial using a study protocol very similar to TAPUR.

Locations: The trial will initially enroll participants at 30 clinical sites located in Michigan, North Carolina, South Carolina, and Idaho, at clinical sites that comprise the Michigan Cancer Research Consortium, the Cancer Research Consortium of West Michigan, the University of Michigan, and the Carolinas HealthCare System’s Levine Cancer Institute – experienced practices that run research trials for the National Cancer Institute and drug manufacturers. ASCO plans to expand to other areas of the country by the end of the year. ASCO is launching the TAPUR study.

To participate: Please discuss with your doctor, or contact the TAPUR team at TAPUR.org or email Pam Mangat at [email protected]. Inclusion and exclusion criteria for the trial may be found here.

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