Active, currently enrolling
Targeted Agent and Profiling Utilization Registry (TAPUR) Study
NCT No.: NCT02693535
Study Type: INTERVENTIONAL
Phase:
Phase II
Region: California - Northern
Acronym: (TAPUR)
Official Title
Targeted Agent and Profiling Utilization Registry (TAPUR) Study
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.
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.
Age Limit
18 years & older
Eligibility Criteria
Inclusion Criteria
|
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;
Please contact study team for additional inclusion criteria;
|
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;
Please contact study team for additional exclusion criteria:
|
Keywords and/or Specific Medical Conditions
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-
Immunoproliferative Disorders
|
|
|
|
|
|
|
|
|
-
Lymphoproliferative Disorders
|
|
|
|
|
-
Neoplasms by Histologic Type
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sponsors
- American Society of Clinical Oncology
|
|