TAPUR: Testing the Use of FDA Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer (Michigan/NC)

Full Text View - ClinicalTrials.gov

This study is currently recruiting participants. (see Contacts and Locations)

Verified April 2016 by American Society of Clinical Oncology

Sponsor:

American Society of Clinical Oncology

Collaborators:

AstraZeneca

Bayer

Bristol-Myers Squibb

Eli Lilly and Company

Genentech, Inc.

Pfizer

Information provided by (Responsible Party):

American Society of Clinical Oncology

ClinicalTrials.gov Identifier:

NCT02693535

First received: February 11, 2016

Last updated: April 13, 2016

Last verified: April 2016

History of Changes

• Full Text View
• Tabular View
• No Study Results Posted
• Disclaimer
• How to Read a Study Record

  Purpose

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.

Condition	Intervention	Phase
Lymphoma, Non-Hodgkin Multiple Myeloma Advanced Solid Tumors	Drug: Erlotinib Drug: Axitinib Drug: Bosutinib Drug: Crizotinib Drug: Palbociclib Drug: Sunitinib Drug: Temsirolimus Drug: Trastuzumab and Pertuzumab Drug: Vemurafenib and Cobimetinib Drug: Vismodegib Drug: Cetuximab Drug: Dasatinib Drug: Regorafenib Drug: Olaparib	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Sirolimus Everolimus Temsirolimus Trastuzumab Erlotinib hydrochloride Erlotinib Cetuximab Dasatinib Axitinib Sunitinib malate Pertuzumab Bosutinib Sunitinib Palbociclib Regorafenib Olaparib Crizotinib Vismodegib Vemurafenib Cobimetinib

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Multiple Myeloma

U.S. FDA Resources

Further study details as provided by American Society of Clinical Oncology:

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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  OS will be estimated using the Kaplan-Meier method
  
  

Estimated Enrollment:	730
Study Start Date:	March 2016
Estimated Primary Completion Date:	March 2019 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1 (VEGFR) Participants receive axitinib - dosage, frequency and duration per label VEGFR mutation, amplification or overexpression)	Drug: Axitinib drug Other Name: Inlyta
Group 2 (Bcr-abl, SRC, LYN, LCK) Participants receive bosutinib- dosage, frequency and duration per label Bcr-abl, SRC, LYN, LCK mutations	Drug: Bosutinib drug Other Name: Bosulif
Group 3 (ALK, ROS1, MET) Participants receive crizotinib - dosage, frequency and duration per label ALK, ROS1, MET mutations	Drug: Crizotinib drug Other Name: Xalkori
Group 4 (CDKN2A/p16, CDK4, CDK6) Participants receive palbociclib - dosage, frequency and duration per label CDKN2A/p16 loss, CDK4, CDK6 amplifications	Drug: Palbociclib drug Other Name: Ibrance
Group 5 (CSF1R, PDGFR, VEGFR) Participants receive sunitinib - dosage, frequency and duration per label CSF1R, PDGFR, VEGFR mutations	Drug: Sunitinib drug Other Name: Sutent
Group 6 (mTOR, TSC) Participants receive temsirolimus - dosage, frequency and duration per label mTOR, TSC mutations	Drug: Temsirolimus drug Other Name: Torisel
Group 7 (EGFR) Participants receive erlotinib - dosage, frequency and duration per label EGFR mutations	Drug: Erlotinib drug Other Name: Tarceva
Group 8 (ERBB2) Participants receive trastuzumab and pertuzumab - dosage, frequency and duration per label (ERBB2 amplifications)	Drug: Trastuzumab and Pertuzumab drug Other Name: Herceptin and Perjeta
Group 9 (BRAFV600E) Participants receive vemurafenib and cobimetinib - dosage, frequency and duration per label BRAFV600E mutations	Drug: Vemurafenib and Cobimetinib drug Other Name: Zelboraf and Cotellic
Group 10 (PTCH1) Participants receive vismodegib - dosage, frequency and duration per label PTCH1 deletion or inactivating mutations	Drug: Vismodegib drug Other Name: Erivedge
Group 11 (KRAS, NRAS and BRAF) Participants receive cetuximab - dosage, frequency and duration per label KRAS, NRAS and BRAF wildtype	Drug: Cetuximab drug Other Name: Erbitux
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	Drug: Dasatinib drug Other Name: Sprycel
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	Drug: Regorafenib drug Other Name: Stivarga
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	Drug: Olaparib drug Other Name: Lynparza

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.

  Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• 18 years of age or older
• Histologically-proven locally advanced or metastatic solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma who is no longer benefitting 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, per RECIST 1.1, 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 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

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

  Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02693535

Contacts

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

Locations

United States, Michigan
University of Michigan	Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Cancer AnswerLine Nurses    800-865-1125    canceranswerline@med.umich.edu
Cancer Research Consortium of West Michigan	Not yet 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, 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@carolinashealthcare.org
Principal Investigator: Edward S. Kim, MD

Sponsors and Collaborators

American Society of Clinical Oncology

AstraZeneca

Bayer

Bristol-Myers Squibb

Eli Lilly and Company

Genentech, Inc.

Pfizer

  More Information

Responsible Party:	American Society of Clinical Oncology
ClinicalTrials.gov Identifier:	NCT02693535     History of Changes
Other Study ID Numbers:	Pro00014171
Study First Received:	February 11, 2016
Last Updated:	April 13, 2016
Health Authority:	United States: Institutional Review Board United States: Data and Safety Monitoring Board

Keywords provided by American Society of Clinical Oncology:

cancer off-label precision medicine targeted therapy

Additional relevant MeSH terms:

Lymphoma, Non-Hodgkin Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell	Paraproteinemias Vascular Diseases Crizotinib Everolimus Pertuzumab Sirolimus Trastuzumab Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antifungal Agents Antineoplastic Agents Enzyme Inhibitors Immunologic Factors Immunosuppressive Agents

ClinicalTrials.gov processed this record on April 27, 2016