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)
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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 |
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Recruitment Status :
Recruiting
First Posted : February 26, 2016
Last Update Posted : May 18, 2023
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Sponsor:
American Society of Clinical Oncology
Collaborators:
AstraZeneca
Bayer
Bristol-Myers Squibb
Eli Lilly and Company
Genentech, Inc.
Merck Sharp & Dohme LLC
Pfizer
Boehringer Ingelheim
Seagen Inc.
Taiho Oncology, Inc.
Information provided by (Responsible Party):
American Society of Clinical Oncology
- Study Details
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- No Results Posted
- Disclaimer
- How to Read a Study Record
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).
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Results in publication or poster presentation format are posted as they become available for individual cohorts at www.tapur.org/news. The results may be accessed at any time. All results will be made available on clinicaltrials.gov at the end of the study. Indexing of available results on PubMed is in progress.
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma, Non-Hodgkin Multiple Myeloma Advanced Solid Tumors | 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: Talazoparib Drug: Atezolizumab and PHESGO Drug: Atezolizumab and Talazoparib Drug: Entrectinib Drug: Larotrectinib Drug: Tucatinib plus Trastuzumab Subcutaneous (SC) Drug: Futibatinib | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 3791 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 |
| Actual Study Start Date : | March 14, 2016 |
| Estimated Primary Completion Date : | December 31, 2024 |
| Estimated Study Completion Date : | December 31, 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Multiple myeloma
| Arm | Intervention/treatment |
|---|---|
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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, CDKN2B loss or mutation
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Drug: Palbociclib
drug
Other Name: Ibrance |
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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
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Drug: Sunitinib
drug
Other Name: Sutent |
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Group 6 (mTOR, TSC)
Participants receive temsirolimus - dosage, frequency and duration per label; acceptable genomic matches include mTOR, TSC1/2, AKT1 mutations
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Drug: Temsirolimus
drug
Other Name: Torisel |
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Group 8 (ERBB2)
Participants receive trastuzumab and pertuzumab - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification or overexpression, and specific ERBB2 mutations
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Drug: Trastuzumab and Pertuzumab
drug
Other Name: Herceptin and Perjeta |
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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
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Drug: Vemurafenib and Cobimetinib
drug
Other Name: Zelboraf and Cotellic |
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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
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Drug: Regorafenib
drug
Other Name: Stivarga |
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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
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Drug: Olaparib
drug
Other Name: Lynparza |
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Group 15 (POLE, POLD1)
Participants receive pembrolizumab - dosage, frequency and duration per label; acceptable genomic matches include specific POLE and POLD1 mutations
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Drug: Pembrolizumab
drug
Other Name: Keytruda |
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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
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Drug: Nivolumab and Ipilimumab
drug
Other Name: Opdivo and Yervoy |
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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, CDKN2B loss or mutation
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Drug: Abemaciclib
drug
Other Name: Verzenio |
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Group 19 (BRCA1/2, PALB2)
Participants receive talazoparib - dosage, frequency and duration per label; acceptable genomic matches include germline or somatic BRCA1/2 and PALB2 mutations
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Drug: Talazoparib
drug
Other Name: Talzenna |
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Group 20 (ERBB2)
Participants receive atezolizumab plus PHESGO - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification or overexpression
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Drug: Atezolizumab and PHESGO
drug
Other Name: Tecentriq and PHESGO |
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Group 21 (BRCA1/2, PALB2, ATM, and others)
Participants receive atezolizumab plus talazoparib - dosage, frequency and duration per label; acceptable genomic matches include germline or somatic mutations in BRCA1/2, PALB2, ATM, ATR, CHEK2, FANCA, RAD51C, NBN, MLH1, MRE11A, CDK12; positive genomic instability score reported on the Myriad MyChoice CDx test; or Genomic Loss of Heterozygosity (LOH) Score above threshold as reported on a FoundationOne CDx test or another qualifying test for TAPUR with MTB approval
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Drug: Atezolizumab and Talazoparib
drug
Other Name: Tecentriq and Talzenna |
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Group 22 (ROS1 fusion)
Participants receive entrectinib - dosage, frequency and duration per label; acceptable genomic matches include any ROS1 fusion
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Drug: Entrectinib
drug
Other Name: Rozlytrek |
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Group 23 (NTRK amplification)
Participants receive larotrectinib - dosage, frequency and duration per label; acceptable genomic matches include NTRK1/2/3 amplification
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Drug: Larotrectinib
drug
Other Name: Vitrakvi |
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Group 24 (ERBB2)
Participants receive tucatinib plus trastuzumab SC - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification or overexpression, and specific ERBB2 mutations
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Drug: Tucatinib plus Trastuzumab Subcutaneous (SC)
drug
Other Name: Tukysa and Herceptin Hylecta |
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Group 25
Participants receive futibatinib- dosage, frequency and duration per label; acceptable genomic matches include FGFR 1,2,3,4 fusion (or other rearrangement) or mutation
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Drug: Futibatinib
drug
Other Name: Lytgobi |
Primary Outcome Measures :
- 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 :
- 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
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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)
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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:
- Absolute neutrophil count ≥ 1.5 x 106/µl
- Hemoglobin > 9.0 g/dl
- Platelets > 75,000/µl
- Total bilirubin < 2.0 mg/ dl, except in patients with Gilbert's Syndrome
- 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)
- Serum creatinine ≤ 1.5 × ULN or calculated or measured creatinine clearance ≥ 50 mL/min/1.73 m2
- Patients must have disease that can be objectively measured by physical or radiographic exam (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 CT scan, 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. Patient's whose disease cannot be objectively measured by physical or radiographic examination (e.g., elevated serum tumor marker only, bone-only disease without an identifiable soft tissue component, or patients with only assessable non-measurable disease) 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. Labs that have registered the test with the NIH Genetic Testing Registry or that provide a report that has been designated as optimized for TAPUR participation are preferred, but not required. 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 for a specified amount of time 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
| Contact: Pam Mangat, MS | www.tapur.org | tapur@asco.org |
Locations
Show 128 study locations
Sponsors and Collaborators
American Society of Clinical Oncology
AstraZeneca
Bayer
Bristol-Myers Squibb
Eli Lilly and Company
Genentech, Inc.
Merck Sharp & Dohme LLC
Pfizer
Boehringer Ingelheim
Seagen Inc.
Taiho Oncology, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | May 18, 2023 |
| Last Verified: | May 2023 |
Keywords provided by American Society of Clinical Oncology:
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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 Nivolumab Trastuzumab Ipilimumab Atezolizumab Pertuzumab Sunitinib Olaparib Palbociclib Temsirolimus Vemurafenib Talazoparib Tucatinib |