Veliparib in Treating Patients With Malignant Solid Tumors That Do Not Respond to Previous Therapy (NCT00892736) | Clinical Trial Compass
CompletedPhase 1
Veliparib in Treating Patients With Malignant Solid Tumors That Do Not Respond to Previous Therapy
United States98 participantsStarted 2009-04-20
Plain-language summary
This phase I trial studies the side effects and best dose of veliparib in treating patients with malignant solid tumors that do not respond to previous therapy. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range19 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have histologically or cytologically confirmed solid tumors that fulfill at least one of the following 3 criteria:
* Have a documented BRCA1/2 mutation and a BRCA related malignancy (primarily breast or ovarian cancers, but also may include prostate or pancreatic cancers); NOTE: Patients enrolled under the Dose Expansion Phase must have a documented BRCA 1/2 mutation; or
* Platinum-refractory ovarian, fallopian tube, or primary peritoneal cancer or
* Basal-like breast cancer whose disease has progressed following standard therapy or who have no acceptable standard treatment options
* All patients without a known, documented BRCA mutation from Myriad Genetic Laboratories must have a probability of harboring a BRCA gene mutation assessed by BRCAPRO computer program
* All patients in whom the probability of having a genetic mutation is \>= 20% must have formal BRCA testing done through Myriad Genetic Laboratories in order to participate in the study
* Although various research based tests have been developed to detect BRCA mutations, due to the fact that these are not Food and Drug Administration (FDA) or Clinical Laboratory Improvement Amendments (CLIA) approved and therefore not reportable to patients, if a patient has diagnosis of a BRAC mutation based on a non-Myriad test, then they must undergo Myriad BRCA gene sequencing to be eligible
* Patients are eligible whether they have a known deleterious BRCA 1 or 2 mutation or a …
What they're measuring
1
MTD, DLT, recommended phase II dose of chronically dosed single-agent veliparib in patients with either a refractory BRCA 1/2- mutated solid cancer; platinum- refractory ovarian, fallopian tube, or primary peritoneal cancer; or basal-like breast cancer