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TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer (TAPUR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02693535
Recruitment Status : Recruiting
First Posted : February 26, 2016
Last Update Posted : March 3, 2020
Sponsor:
Collaborators:
AstraZeneca
Bayer
Bristol-Myers Squibb
Eli Lilly and Company
Genentech, Inc.
Merck Sharp & Dohme Corp.
Pfizer
Boehringer Ingelheim
Information provided by (Responsible Party):
American Society of Clinical Oncology

Brief Summary:

The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.

NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact TAPUR@asco.org, or if a patient, your nearest participating TAPUR site (see participating centers).

Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.


Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Multiple Myeloma Advanced Solid Tumors Drug: Crizotinib Drug: Palbociclib Drug: Sunitinib Drug: Temsirolimus Drug: Trastuzumab and Pertuzumab Drug: Vemurafenib and Cobimetinib Drug: Regorafenib Drug: Olaparib Drug: Pembrolizumab Drug: Nivolumab and Ipilimumab Drug: Abemaciclib Drug: Afatinib Drug: Talazoparib Phase 2

Detailed Description:
The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3279 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Study Start Date : March 2016
Estimated Primary Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Group 3 (ALK, ROS1, MET)
Participants receive crizotinib - dosage, frequency and duration per label; acceptable genomic matches include ALK fusion or mutation, ROS1 fusion, MET amplification or mutation, MET exon 14 alteration, RON amplification or mutation
Drug: Crizotinib
drug
Other Name: Xalkori

Group 4 (CDKN2A, CDK4, CDK6)
Participants receive palbociclib - dosage, frequency and duration per label; acceptable genomic matches include CDKN2A loss or mutation, CDK4, CDK6 amplifications
Drug: Palbociclib
drug
Other Name: Ibrance

Group 5 (CSF1R,PDGFR,VEGFR)
Participants receive sunitinib - dosage, frequency and duration per label; acceptable genomic matches include CSF1R, PDGFR, VEGFR1/2/3, KIT, FLT-3, RET, FGFR1/2/3, VHL amplifications or mutations
Drug: Sunitinib
drug
Other Name: Sutent

Group 6 (mTOR, TSC)
Participants receive temsirolimus - dosage, frequency and duration per label; acceptable genomic matches include mTOR, TSC1/2, AKT1 mutations
Drug: Temsirolimus
drug
Other Name: Torisel

Group 8 (ERBB2)
Participants receive trastuzumab and pertuzumab - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification, overexpression, and specific mutations
Drug: Trastuzumab and Pertuzumab
drug
Other Name: Herceptin and Perjeta

Group 9 (BRAF V600E/D/K/R)
Participants receive vemurafenib and cobimetinib - dosage, frequency and duration per label; acceptable genomic matches include BRAF V600E/D/K/R mutations
Drug: Vemurafenib and Cobimetinib
drug
Other Name: Zelboraf and Cotellic

Group 13 (RET,VEGFR1/2/3,KIT,PDGFRβ,RAF-1,BRAF)
Participants receive regorafenib - dosage, frequency and duration per label; acceptable genomic matches include RET, VEGFR1/2/3, KIT, PDGFRβ, RAF-1, BRAF mutations or amplifications
Drug: Regorafenib
drug
Other Name: Stivarga

Group 14 (BRCA1/2; ATM)
Participants receive olaparib - dosage, frequency and duration per label; acceptable genomic matches include germline or somatic BRCA1/2 inactivating mutations; ATM mutations or deletions
Drug: Olaparib
drug
Other Name: Lynparza

Group 15 (POLE, POLD1, high mutational load)
Participants receive pembrolizumab - dosage, frequency and duration per label; acceptable genomic matches include specific POLE and POLD1 mutations, tumor mutational burden as defined in protocol
Drug: Pembrolizumab
drug
Other Name: Keytruda

Group 16 (MSI-H, high mutational load and others)
Participants receive nivolumab and ipilimumab - dosage, frequency and duration per label; acceptable genomic matches include MSI high status, high tumor mutational burden, MLH1, MSH2/6, PMS2, EPCAM mutations, specific POLE or POLD1 mutations, BRCA1/2, ATM, MSH3, PMS1, MLH3, EXO1, RFC1/2/3/4/5, PCNA, RPA1/2/3/4, and SSBP1 loss of function mutations
Drug: Nivolumab and Ipilimumab
drug
Other Name: Opdivo and Yervoy

Group 17 (CDKN2A, CDK4, CDK6)
Participants receive abemaciclib - dosage, frequency and duration per label; acceptable genomic matches include CDKN2A loss or mutation, CDK4, CDK6 amplifications
Drug: Abemaciclib
drug
Other Name: Verzenio

Group 18 (NRG1)
Participants receive afatinib - dosage, frequency and duration per label; acceptable genomic matches include NRG1 fusions
Drug: Afatinib
drug
Other Name: Gilotrif

Group 19 (BRCA1/2, PALB2)
Participants receive Participants receive talazoparib - dosage, frequency and duration per label; acceptable genomic matches include germline or somatic BRCA1/2 and PALB2 mutations
Drug: Talazoparib
drug
Other Name: Talzenna




Primary Outcome Measures :
  1. Objective Response Rate defined as % of participants in a cohort with complete or partial response or with stable disease according to standard response criteria [ Time Frame: Assessed at 16 weeks of treatment ]
    Each cohort includes participants with the same tumor type, genomic variant and study drug. For solid tumors, the Response Evaluation Criteria for Solid Tumors (RECIST) criteria will be used, for non-Hodgkin Lymphoma, the Lugano Criteria will be used, and for multiple myeloma, the International Uniform Response Criteria for Multiple Myeloma will be used.


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Duration of survival from registration on study until death from any cause, assessed throughout end of study, up to 3 years ]
    OS will be estimated using the Kaplan-Meier method



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 12 years of age or older (*Restrictions apply. Not all therapies are available for patients <18)
  • Histologically-proven locally advanced or metastatic solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma who is no longer benefiting from standard anti-cancer treatment or for whom, in the opinion of the treating physician, no such treatment is available or indicated
  • Performance status 0-2 (Per Eastern Cooperative Oncology Group (ECOG) criteria)
  • Patients must have acceptable organ function as defined below. However, as noted above, drug-specific inclusion/exclusion criteria specified in the protocol appendix for each agent will take precedence for this and all inclusion criteria:

    1. Absolute neutrophil count ≥ 1.5 x 106/µl
    2. Hemoglobin > 9.0 g/dl
    3. Platelets > 75,000/µl
    4. Total bilirubin < 2.0 mg/ dl, except in patients with Gilbert's Syndrome
    5. Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) serum glutamic-pyruvic transaminase (SGPT) < 2.5 x institutional upper limit of normal (ULN) (or < 5 x ULN in patients with known hepatic metastases)
    6. Serum creatinine ≤ 1.5 × ULN or calculated or measured creatinine clearance ≥ 50 mL/min/1.73 m2
  • Patients must have measurable or evaluable disease (per RECIST v1.1 for solid tumor, Lugano criteria for non Hodgkin lymphoma or International Myeloma Working Group criteria for multiple myeloma), defined, as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral computed tomography (CT) scan, Magnetic Resonance Imaging (MRI), or a subcutaneous or superficial lesion that can be measured with calipers by clinical exam. For lymph nodes, the short axis must be ≥15 mm. Patients who have assessable disease by physical or radiographic examination but do not meet these definitions of measurable disease are eligible and will be considered to have evaluable disease. Patient's whose disease cannot be objectively measured by physical or radiographic examination (e.g., elevated serum tumor marker only) are NOT eligible
  • Results must be available from a genomic test or immunohistochemistry (IHC) test for protein expression performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified and College of American Pathologists (CAP)-accredited or New York State accredited (for labs offering services to residents of NY) laboratory that has registered the test with the National Institutes of Health (NIH) Genetic Test Registry or has established an integration with the TAPUR platform. The genomic or IHC test used to qualify a patient for participation in TAPUR may have been performed on any specimen of the patient's tumor obtained at any point during the patient's care at the discretion of the patient's treating physician. Genomic assays performed on cell-free DNA in plasma ("liquid biopsies") will also be acceptable if the genomic analysis is performed in a laboratory that meets the criteria described above.
  • Ability to understand and the willingness to sign a written informed consent/assent document
  • Have a tumor genomic profile for which single agent treatment with one of the FDA approved targeted anti-cancer drugs included in this study has potential clinical benefit based on the criteria described in protocol
  • For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome
  • Because of the risks of drug treatment to the developing fetus, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation, and for four months following completion of study therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study or if she is the partner of a male participant in this study and becomes pregnant while he is participating in this study, she should inform her or her partner's treating physician immediately as well as her obstetrician. Female study patients who become pregnant must immediately discontinue treatment with any study therapy. Male patients should avoid impregnating a female partner. Male study patients, even if surgically sterilized, (i.e. post-vasectomy) must agree to one of the following: practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or completely abstain from sexual intercourse

Note: TAPUR does not explicitly exclude any type of solid tumor, but the patient must have measurable and evaluable disease per RECIST v1.1

Exclusion Criteria:

  • Patients whose disease is not measurable or cannot be assessed by radiographic imaging or physical examination (e.g., elevated serum tumor marker only) are not eligible
  • Patients with primary brain tumors or leptomeningeal metastases are excluded
  • Patients with previously treated brain metastases are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within the 3 months prior to registration. All patients with previously treated brain metastases must be clinically stable for at least 1 month after completion of treatment and off steroid treatment for one month prior to study enrollment.
  • Patients with known progressive brain metastases are eligible but additional eligibility criteria apply

Note: there are additional exclusion criteria that may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02693535


Contacts
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Contact: Pam Mangat, MS www.tapur.org pam.mangat@asco.org

Locations
Hide Hide 27 study locations
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United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center Recruiting
Birmingham, Alabama, United States, 35294
Contact: Betty Prescott, RN, OCN    205-934-4209    bprescott@uabmc.edu   
Principal Investigator: Eddy Yang, MD         
United States, Arizona
Cancer Treatment Centers of America-Phoenix Recruiting
Phoenix, Arizona, United States, 85338
Contact: Jessica Coats, MS, RN, CCRC    623-207-3899    jessica.coats@ctca-hope.com   
Principal Investigator: Ashish Sangal, MD         
United States, California
The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate Recruiting
Los Angeles, California, United States, 90025
Contact: Saba Mukarram    310-231-2181    smukarram@theangelesclinic.org   
Principal Investigator: Omid Hamid, MD         
Sutter Cancer Research Consortium Recruiting
San Francisco, California, United States, 94115
Contact: Peter Gasper    415-600-3472    peter@cpmcri.org   
Principal Investigator: Stacy D'Andre, MD         
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Elaine Laginess, BS    305-243-6248    esl76@med.miami.edu   
Principal Investigator: Carmen Calfa, MD         
United States, Georgia
Cancer Treatment Centers of America - Atlanta Recruiting
Atlanta, Georgia, United States, 30265
Contact: Quin Boynes, MSPH    770-400-7080    Quin.Boynes@ctca-hope.com   
Principal Investigator: Eugene Ahn, MD         
Emory University Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Somini John    404-778-7664    somini.m.john@emory.edu   
Principal Investigator: Olatunji Alese, MD         
United States, Hawaii
The Queen's Medical Center (The University of Texas MD Anderson Cancer Center) Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Holly Oakley, CCRC    713-745-0746    HDOakley@mdanderson.org   
Principal Investigator: Funda Meric-Bernstam, MD         
United States, Illinois
Cancer Treatment Centers of America-Chicago Recruiting
Chicago, Illinois, United States, 60099
Contact: Anjanette Sorensen, BSN, RN    847-872-4701    anjanette.sorensen@ctca-hope.com   
Principal Investigator: Eugene Ahn, MD         
United States, Indiana
Community Health Network (The University of Texas MD Anderson Cancer Center) Recruiting
Indianapolis, Indiana, United States, 46250
Contact: Holly Oakley, CCRC    713-745-0746    HDOakley@mdanderson.org   
Principal Investigator: Funda Meric-Bernstam, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Cancer AnswerLine Nurses    800-865-1125    canceranswerline@med.umich.edu   
Principal Investigator: Ajjai Alva, MBBS         
Cancer Research Consortium of West Michigan Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Connie Szczepanek, RN    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost, MD         
Michigan Cancer Research Consortium Recruiting
Traverse City, Michigan, United States, 48341
Contact: Beth LaVasseur, RN, MS    734-712-5658    Beth.LaVasseur@stjoeshealth.org   
Contact    877-590-5995      
Principal Investigator: Philip Stella, MD         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Brandie Booker, RN, BSN, OCN    402-559-8197    brandie.booker@unmc.edu   
Principal Investigator: Alissa Marr, MD         
United States, North Carolina
Carolina's HealthCare System's Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28277
Contact: Kelly Bumgarner, RN, CCRP    704-403-2520    Kelly.Bumgarner@atriumhealth.org   
Principal Investigator: Edward S. Kim, MD         
United States, North Dakota
Sanford Health- Bismarck Recruiting
Bismarck, North Dakota, United States, 58501
Contact: Peter Kurniali, MD    701-323-5741    peter.kurniali@sanfordhealth.org   
Principal Investigator: Peter Kurniali, MD         
Sanford Health- Fargo Recruiting
Fargo, North Dakota, United States, 58122
Contact: Anu Gaba, MD    701-234-6161    anu.gaba@sanfordhealth.org   
Principal Investigator: Anu Gaba, MD         
United States, Oklahoma
Cancer Treatment Centers of America-Tulsa Recruiting
Tulsa, Oklahoma, United States, 74133
Contact: Tyler Pilkington    918-286-5308    Tyler.Pilkington@ctca-hope.com   
Principal Investigator: Theodore Pollock, DO         
United States, Oregon
Providence Health & Services Recruiting
Portland, Oregon, United States, 97213
Contact: Melissa Pomeroy, RN, BSN, OCN    503-215-2714    Melissa.Pomeroy@providence.org   
Principal Investigator: Walter Urba, MD         
United States, Pennsylvania
Lehigh Valley Health Network Cancer Institute (Michigan Cancer Research Consortium) Recruiting
Allentown, Pennsylvania, United States, 18105
Contact: Beth LaVasseur, RN, MS    734-712-5658    Beth.LaVasseur@stjoeshealth.org   
Contact    877-590-5995      
Principal Investigator: Philip Stella, MD         
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Fathima S Sheriff    215-728-4094    fathima.sheriff@fccc.edu   
Principal Investigator: Margaret von Mehren, MD         
Cancer Treatment Centers of America-Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19124
Contact: Marianne Bonner, RN, BSN, CCRP    215-537-4881    marianne.bonner@ctca-hope.com   
Principal Investigator: Pamela Crilley, DO         
United States, South Dakota
Sanford Cancer Center Oncology Clinic and Pharmacy Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Steven Powell, MD    605-328-5000    steven.powell@sanfordhealth.org   
Principal Investigator: Steven Powell, MD         
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Holly Oakley, CCRC    713-745-0746    HDOakley@mdanderson.org   
Principal Investigator: Funda Meric-Bernstam, MD         
United States, Utah
Intermountain Healthcare Recruiting
Salt Lake City, Utah, United States, 84107
Contact: Tracy Taylor    801-507-3953    tracy.taylor@imail.org   
Contact: Angi Kahrs, CCRP    435-251-4742    Angi.Cox@imail.org   
Principal Investigator: Ramya Thota, M.D.         
Principal Investigator: Derrick Haslem, M.D.         
United States, Virginia
Inova Schar Cancer Institute Recruiting
Fairfax, Virginia, United States, 22042
Contact: Lindsey Tishman, MHA, CCRC    703-970-6488    lindsey.tishman@inova.org   
Principal Investigator: Timothy Cannon, MD         
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Contact: Leah Clemente    206-386-2227    Leah.Clemente@swedish.org   
Principal Investigator: Philip Gold, MD         
Sponsors and Collaborators
American Society of Clinical Oncology
AstraZeneca
Bayer
Bristol-Myers Squibb
Eli Lilly and Company
Genentech, Inc.
Merck Sharp & Dohme Corp.
Pfizer
Boehringer Ingelheim
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Responsible Party: American Society of Clinical Oncology
ClinicalTrials.gov Identifier: NCT02693535    
Other Study ID Numbers: Pro00014171
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: February 2020
Keywords provided by American Society of Clinical Oncology:
cancer
off-label
precision medicine
targeted therapy
Additional relevant MeSH terms:
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Multiple Myeloma
Lymphoma, Non-Hodgkin
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lymphoma
Lymphatic Diseases
Pembrolizumab
Trastuzumab
Nivolumab
Ipilimumab
Pertuzumab
Sunitinib
Olaparib
Palbociclib
Afatinib
Vemurafenib
Crizotinib
Talazoparib
Antineoplastic Agents, Immunological