Talazoparib in Treating Patients With Recurrent, Refractory, Advanced, or Metastatic Cancers and … (NCT02286687) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Talazoparib in Treating Patients With Recurrent, Refractory, Advanced, or Metastatic Cancers and Alterations in the BRCA Genes
United States150 participantsStarted 2014-12-22
Plain-language summary
This phase II trial studies how well talazoparib works in treating patients with cancers that have returned after a period of improvement, do not respond to treatment, or have spread to other parts of the body, and have alterations in the breast cancer, early onset (BRCA) genes. Talazoparib may cause tumor cells to die by blocking an enzyme that protects the tumor cells from damage.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with advanced or metastatic cancer that is refractory to standard therapy or has relapsed after standard therapy
* Patients must have one of the following: somatic mutations or deletions in BRCA1 or BRCA2; genomic alterations in other BRCA pathway genes (subcohorts: a. ATM, b. PALB2, c. other genes, e.g. Fanconi Anemia genes, ARID1A, MER11, RAD50, NBS1, ATR; amplification of EMSY); or germline mutation in BRCA1 or BRCA 2 (not breast or ovarian cancer)
* Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
* Absolute neutrophil count \>= 1500/mL
* Platelets \>= 100,000/mL
* Hemoglobin \>= 9 g/dL (or \>= 5.6 mmol/L)
* Serum creatinine =\< 1.5 x upper limit of normal (ULN) (or glomerular filtration rate \[GFR\] \>= 60 ml/min for patients with creatinine \> 1.5 x ULN)
* Serum total bilirubin =\< 1.5 x ULN (direct bilirubin =\< ULN if total bilirubin \[bili\] \> 1.5 x ULN)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x ULN (or =\< 5 x ULN if liver metastases \[mets\])
* International normalized ratio (INR) or prothrombin time (PT) =\< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulant…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1My tumor has a BRCA1, BRCA2, PALB2, or ATM gene alteration — based on my specific mutation type and cancer, does my doctor think I could be a good candidate to discuss this talazoparib trial with the study team?
2This is a Phase 2 trial, which means researchers are still building evidence on how well talazoparib works across different cancer types — given that, what does my doctor think is currently known about its effectiveness and safety profile for someone with my diagnosis?
3The trial is 'active but not recruiting,' meaning they're no longer enrolling new patients — are there other open trials or approved uses of talazoparib or similar PARP inhibitors that I should be looking into instead?
4The trial measures 'clinical benefit' using a standard tumor response system called RECIST 1.1 — can my doctor explain what that actually means in practical terms, and how likely it is that someone with my cancer type might see that kind of response based on data shared so far?
5Before considering a trial like this, should I first try any standard approved treatments for my cancer type, or does my doctor think moving toward a PARP inhibitor approach like talazoparib makes sense now given my gene mutation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical benefit by Response Evaluation Criteria in Solid Tumors 1.1