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New treatment option for Lymphoma, Non-Hodgkin
Official title 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
ClinicalTrials.gov ID: NCT02693535
What this study is testing
What is Palbociclib?
Palbociclib is an investigational medicine, being studied as a potential treatment for lymphoma, non-hodgkin.
Also referred to as Ibrance.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- 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...
- 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/
You likely can't join if
- specified in the protocol appendix for each agent will take precedence for this and all inclusion criteria:
- Absolute neutrophil count ≥ 1.5 x 106/µl
- Hemoglobin \> 9.0 g/dl
- Platelets \> 75,000/µl
- Total bilirubin \< 2.0 mg/ dl, except in patients with Gilbert's Syndrome
- Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) serum glutamic-pyruvic...
See the full eligibility 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...
- 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/
- specified in the protocol appendix for each agent will take precedence for this and all inclusion criteria:
- Absolute neutrophil count ≥ 1.5 x 106/µl
- Hemoglobin \> 9.0 g/dl
- Platelets \> 75,000/µl
- Total bilirubin \< 2.0 mg/ dl, except in patients with Gilbert's Syndrome
- 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...
- 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 physical or radiographic exam (per RECIST v1.1 for solid tumor, Lugano criteria for non-Hodgkin lymphoma or International Myeloma Working Group criteria for...
- 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...
- 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...
- 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 new, untreated or progressive 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...
- Patients with known progressive brain metastases are eligible but additional eligibility criteria apply. Note: there are additional exclusion criteria that may apply
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Auburn, California, United States
- Berkeley, California, United States
- Los Angeles, California, United States
- Oakland, California, United States
- Palo Alto, California, United States
- Roseville, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- San Jose, California, United States
- San Leandro, California, United States
- Santa Barbara, California, United States
- Santa Clara, California, United States
- Santa Cruz, California, United States
- Sunnyvale, California, United States
- Vallejo, California, United States
- Walnut Creek, California, United States
- Bridgeport, Connecticut, United States
- Hartford, Connecticut, United States
+ 126 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Auburn, California, United States; Berkeley, California, United States; Los Angeles, California, United States; Oakland, California, United States and 140 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.