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

Overview

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.

SparkCures ID 801
Trial Phase Phase 2
Enrollment 3581 Patients
Treatments
Trial Sponsors
  • American Society of Clinical Oncology
Trial Collaborators
  • Eli Lilly and Company
  • Bristol Myers Squibb
  • Genentech
  • Pfizer
  • Boehringer Ingelheim
  • Seattle Genetics
NCT Identifier

NCT02693535

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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 disease that can be objectively measured by physicial or radiographic exam 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, 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

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Verified Winship Cancer Institute of Emory University

SparkCures Verified Accurate, up-to-date information. Learn more


Cancer Treatment Centers of America Western Regional Medical Center

Goodyear, AZ

Sutter Auburn Faith Hospital

Auburn, CA

Sutter Alta Bates

Berkeley, CA

Sutter Cancer Research Consortium

Novato, CA

Palo Alto Medical Foundation Health Care

Palo Alto, CA

Sutter General Hospital

Sacramento, CA

Sutter Palo Alto Medical Foundation San Francisco

San Francisco, CA

California Pacific Medical Center Pacific Campus

San Francisco, CA

Palo Alto Medical Foundation

Santa Cruz, CA

Sutter Palo Alto Medical Foundation

Sunnyvale, CA

Holy Cross Hospital (Michigan Cancer Research Consortium)

Fort Lauderdale, FL

Cancer Treatment Centers of America Southeastern Regional Medical Center

Newnan, GA

Queen's Medical Center

Honolulu, HI

Cancer Treatment Centers of America Midwestern Regional Medical Center

Zion, IL

Community Health Network

Indianapolis, IN

Northern Light Cancer Care

Brewer, ME

Penobscot Bay Medical Center

Rockport, ME

Michigan State University (Grand Rapids)

Grand Rapids, MI

Munson Medical Center

Traverse City, MI

St. Joseph Mercy Hospital

Ypsilanti, MI

Sanford Bismarck Medical Center

Bismarck, ND

Sanford Medical Center

Fargo, ND

New Hampshire Oncology and Hematology (Concord)

Concord, NH

Kettering Medical Center

Kettering, OH

Providence Portland Medical Center

Portland, OR

Lehigh Valley Health Network Cancer Institute

Allentown, PA

Sanford Cancer Center

Sioux Falls, SD

Intermountain Medical Center

Murray, UT

Inova Fairfax Medical Hospital Inova Schar Cancer Institute

Falls Church, VA

Alabama
Arizona
Cancer Treatment Centers of America Western Regional Medical Center

Goodyear, AZ

California
Sutter Auburn Faith Hospital

Auburn, CA

Sutter Alta Bates

Berkeley, CA

Sutter Cancer Research Consortium

Novato, CA

Palo Alto Medical Foundation Health Care

Palo Alto, CA

Sutter General Hospital

Sacramento, CA

Sutter Palo Alto Medical Foundation San Francisco

San Francisco, CA

California Pacific Medical Center Pacific Campus

San Francisco, CA

Palo Alto Medical Foundation

Santa Cruz, CA

Sutter Palo Alto Medical Foundation

Sunnyvale, CA

Florida
Holy Cross Hospital (Michigan Cancer Research Consortium)

Fort Lauderdale, FL

Georgia
Verified Winship Cancer Institute of Emory University

SparkCures Verified Accurate, up-to-date information. Learn more


Cancer Treatment Centers of America Southeastern Regional Medical Center

Newnan, GA

Hawaii
Queen's Medical Center

Honolulu, HI

Illinois
Cancer Treatment Centers of America Midwestern Regional Medical Center

Zion, IL

Indiana
Community Health Network

Indianapolis, IN

Maine
Northern Light Cancer Care

Brewer, ME

Penobscot Bay Medical Center

Rockport, ME

Michigan
Michigan State University (Grand Rapids)

Grand Rapids, MI

Munson Medical Center

Traverse City, MI

St. Joseph Mercy Hospital

Ypsilanti, MI

Nebraska
New Hampshire
New Hampshire Oncology and Hematology (Concord)

Concord, NH

North Carolina
North Dakota
Sanford Bismarck Medical Center

Bismarck, ND

Sanford Medical Center

Fargo, ND

Ohio
Kettering Medical Center

Kettering, OH

Oregon
Providence Portland Medical Center

Portland, OR

Pennsylvania
Lehigh Valley Health Network Cancer Institute

Allentown, PA

South Dakota
Sanford Cancer Center

Sioux Falls, SD

Texas
Utah
Intermountain Medical Center

Murray, UT

Virginia
Inova Fairfax Medical Hospital Inova Schar Cancer Institute

Falls Church, VA

Washington

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