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

NCT02693535

Last updated date
Study Location
The Queen's Medical Center (The University of Texas MD Anderson Cancer Center)
Honolulu, Hawaii, 96813, United States
Contact
www.tapur.org

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Hodgkin Lymphoma, Multiple Myeloma, Advanced Solid Tumors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Pfizer Clinical Trials Contact Center

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Non-Hodgkin Lymphoma, Multiple Myeloma, Advanced Solid TumorsTAPUR: 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
NCT02693535
  1. Honolulu, Hawaii
  2. Indianapolis, Indiana
  3. Springfield, Massachusetts
  4. Allentown, Pennsylvania
  5. Birmingham, Alabama
  6. Phoenix, Arizona
  7. Los Angeles, California
  8. San Francisco, California
  9. Miami, Florida
  10. Atlanta, Georgia
  11. Atlanta, Georgia
  12. Chicago, Illinois
  13. Ann Arbor, Michigan
  14. Grand Rapids, Michigan
  15. Traverse City, Michigan
  16. Omaha, Nebraska
  17. Charlotte, North Carolina
  18. Bismarck, North Dakota
  19. Fargo, North Dakota
  20. Tulsa, Oklahoma
  21. Portland, Oregon
  22. Philadelphia, Pennsylvania
  23. Philadelphia, Pennsylvania
  24. Sioux Falls, South Dakota
  25. Houston, Texas
  26. Salt Lake City, Utah
  27. Fairfax, Virginia
  28. Seattle, Washington
ALL GENDERS
12 Years+
years
MULTIPLE SITES
Non-Hodgkin Lymphoma, Multiple Myeloma, Advanced Solid TumorsCanadian Profiling and Targeted Agent Utilization Trial (CAPTUR)
NCT03297606
  1. Edmonton, Alberta
  2. Vancouver, British Columbia
  3. Kingston, Ontario
  4. London, Ontario
  5. Ottawa, Ontario
  6. Toronto, Ontario
  7. Montreal, Quebec
  8. Regina, Saskatchewan
  9. Saskatoon, Saskatchewan
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 [email protected], or if a patient, your nearest participating TAPUR site (see participating centers).

******************************************************************************************************************************************************************************

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.

******************************************************************************************************************************************************************************

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: 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
  • Drug: Abemaciclib
    drug
    Other Name: Verzenio
  • Drug: Afatinib
    drug
    Other Name: Gilotrif
  • Drug: Talazoparib
    drug
    Other Name: Talzenna
Study Arms  ICMJE
  • 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
    Intervention: Drug: Crizotinib
  • 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
    Intervention: Drug: Palbociclib
  • 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
    Intervention: Drug: Sunitinib
  • Group 6 (mTOR, TSC)
    Participants receive temsirolimus - dosage, frequency and duration per label; acceptable genomic matches include mTOR, TSC1/2, AKT1 mutations
    Intervention: Drug: Temsirolimus
  • Group 8 (ERBB2)
    Participants receive trastuzumab and pertuzumab - dosage, frequency and duration per label; acceptable genomic matches include ERBB2 amplification, overexpression, and 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; acceptable genomic matches include BRAF V600E/D/K/R mutations
    Intervention: Drug: Vemurafenib and Cobimetinib
  • Group 13 (RET,VEGFR1/2/3,KIT,PDGFR?,RAF-1,BRAF)
    Participants receive regorafenib - dosage, frequency and duration per label; acceptable genomic matches include RET, VEGFR1/2/3, KIT, PDGFR?, RAF-1, BRAF mutations or amplifications
    Intervention: Drug: Regorafenib
  • 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
    Intervention: Drug: Olaparib
  • 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
    Intervention: Drug: Pembrolizumab
  • 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
    Intervention: Drug: Nivolumab and Ipilimumab
  • 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
    Intervention: Drug: Abemaciclib
  • Group 18 (NRG1)
    Participants receive afatinib - dosage, frequency and duration per label; acceptable genomic matches include NRG1 fusions
    Intervention: Drug: Afatinib
  • 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
    Intervention: Drug: Talazoparib
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: December 12, 2019)
3279
Original Estimated Enrollment  ICMJE
 (submitted: February 23, 2016)
680
Estimated Study Completion Date  ICMJE December 31, 2023
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, 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

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, MSwww.tapur.org[email protected]
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
  • Boehringer Ingelheim
Investigators  ICMJE Not Provided
PRS Account American Society of Clinical Oncology
Verification Date August 2020

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