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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 : February 25, 2019
Sponsor:
Collaborators:
AstraZeneca
Bayer
Bristol-Myers Squibb
Eli Lilly and Company
Genentech, Inc.
Merck Sharp & Dohme Corp.
Pfizer
Information provided by (Responsible Party):
American Society of Clinical Oncology

Tracking Information
First Submitted Date  ICMJE February 11, 2016
First Posted Date  ICMJE February 26, 2016
Last Update Posted Date February 25, 2019
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02693535 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2016)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE Targeted Agent and Profiling Utilization Registry (TAPUR) Study
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).

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Advanced Solid Tumors
Intervention  ICMJE
  • Drug: Crizotinib
    drug
    Other Name: Xalkori
  • Drug: Palbociclib
    drug
    Other Name: Ibrance
  • Drug: Sunitinib
    drug
    Other Name: Sutent
  • Drug: Temsirolimus
    drug
    Other Name: Torisel
  • Drug: Trastuzumab and Pertuzumab
    drug
    Other Name: Herceptin and Perjeta
  • Drug: Vemurafenib and Cobimetinib
    drug
    Other Name: Zelboraf and Cotellic
  • Drug: Cetuximab
    drug
    Other Name: Erbitux
  • Drug: Dasatinib
    drug
    Other Name: Sprycel
  • Drug: Regorafenib
    drug
    Other Name: Stivarga
  • Drug: Olaparib
    drug
    Other Name: Lynparza
  • Drug: Pembrolizumab
    drug
    Other Name: Keytruda
  • Drug: Nivolumab and Ipilimumab
    drug
    Other Name: Opdivo and Yervoy
Study Arms  ICMJE
  • Group 3 (ALK, ROS1, MET)
    Participants receive crizotinib - dosage, frequency and duration per label ALK, ROS1, MET mutations
    Intervention: Drug: Crizotinib
  • Group 4 (CDKN2A, CDK4, CDK6)
    Participants receive palbociclib - dosage, frequency and duration per label CDKN2A loss or mutation, CDK4, CDK6 amplifications
    Intervention: Drug: Palbociclib
  • Group 5 (CSF1R,PDGFR,VEGFR)
    Participants receive sunitinib - dosage, frequency and duration per label CSF1R, PDGFR, VEGFR mutations
    Intervention: Drug: Sunitinib
  • Group 6 (mTOR, TSC)
    Participants receive temsirolimus - dosage, frequency and duration per label mTOR, TSC mutations
    Intervention: Drug: Temsirolimus
  • Group 8 (ERBB2)
    Participants receive trastuzumab and pertuzumab - dosage, frequency and duration per label ERBB2 amplification, overexpression, specific mutations
    Intervention: Drug: Trastuzumab and Pertuzumab
  • Group 9 (BRAF V600E/D/K/R)
    Participants receive vemurafenib and cobimetinib - dosage, frequency and duration per label BRAF V600E/D/K/R mutations
    Intervention: Drug: Vemurafenib and Cobimetinib
  • Group 11 (KRAS, NRAS and BRAF wt)
    Participants receive cetuximab - dosage, frequency and duration per label KRAS, NRAS and BRAF wildtype
    Intervention: Drug: Cetuximab
  • Group 12 (Bcr-abl, SRC, KIT, PDGFRB, EPHA2, FYN, LCK, YES1)
    Participants receive dasatinib - dosage, frequency and duration per label Bcr-abl, SRC, KIT, PDGFRB, EPHA2, FYN, LCK, YES1 mutations
    Intervention: Drug: Dasatinib
  • Group 13 (RET,VEGFR1/2/3,KIT,PDGFRβ,RAF-1,BRAF
    Participants receive regorafenib - dosage, frequency and duration per label RET, VEGFR1, VEGFR2, VEGFR3, KIT, PDGFRβ, RAF-1, BRAF mutations/amplifications
    Intervention: Drug: Regorafenib
  • Group 14 (BRCA1/BRCA2; ATM)
    Participants receive olaparib - dosage, frequency and duration per label Germline or somatic BRCA1/BRCA2 inactivating mutations; ATM mutations or deletions
    Intervention: Drug: Olaparib
  • Group 15 (POLE/POLD1;high mutational load)
    Participants receive pembrolizumab - dosage, frequency and duration per label Note: high mutational load defined per protocol
    Intervention: Drug: Pembrolizumab
  • Group 16 (MSIH, high mutational load and others)
    Participants receive nivolumab and ipilimumab- dosage, frequency and duration per label Note: high mutational load defined per protocol, there are other targets not listed here due to character limits
    Intervention: Drug: Nivolumab and Ipilimumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 6, 2019)
2980
Original Estimated Enrollment  ICMJE
 (submitted: February 23, 2016)
680
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
    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, College of American Pathologists (CAP) -accredited, 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 are excluded. Patients with known progressive brain metastases determined by serial imaging or declining neurologic function in the opinion of the treating physician are not eligible. 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.

Note: there are additional exclusion criteria that may apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pam Mangat, MS www.tapur.org pam.mangat@asco.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02693535
Other Study ID Numbers  ICMJE Pro00014171
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party American Society of Clinical Oncology
Study Sponsor  ICMJE American Society of Clinical Oncology
Collaborators  ICMJE
  • AstraZeneca
  • Bayer
  • Bristol-Myers Squibb
  • Eli Lilly and Company
  • Genentech, Inc.
  • Merck Sharp & Dohme Corp.
  • Pfizer
Investigators  ICMJE Not Provided
PRS Account American Society of Clinical Oncology
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP