Date: 2016-05-23
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: QuantumLeap Healthcare Collaborative (USA - CA) Medivation (USA - CA)
Product: talazoparib
Action
mechanism: enzyme inhibitor/poly ADP ribose polymerase PARP inhibitor/PARP inhibitor. Talazoparib is a potent and specific inhibitor of PARP 1 and 2 that is being developed by Medivation for the treatment of selected solid tumors. In pre-clinical studies, talazoparib has shown single-agent anti-tumor activity, as well as synergy in combination with lowered doses of DNA-damaging agents, due to its dual mechanisms of cytotoxicity, PARP trapping, and inhibition of PARP enzyme activity. Trapping of PARP on DNA impairs DNA replication resulting in tumor cell death.
Disease: advanced breast cancer
Therapeutic area: Cancer - Oncology
Country: Canada, USA
Trial
details: I-SPY 2 Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2) is a phase 2 study investigating the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success. (NCT01042379)
Latest
news: * On May 23, 2016, Medivation announced that the talazoparib-containing arm of the I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2) has been activated. I-SPY 2, sponsored by the QuantumLeap Healthcare Collaborative, combines a personalized medicine approach and novel trial design to study investigational treatments in the neoadjuvant setting and is being conducted by a consortium consisting of the FDA, the National Cancer Institute (NCI), pharmaceutical and biotech companies, leading academic medical centers and patient advocates. The I-SPY 2 TRIAL is a Phase II, randomized, controlled, multi-center trial for women with newly diagnosed, locally advanced breast cancer (Stage II/III). The trial employs an adaptive design, matching experimental therapies with patients based on the use of biomarkers, investigating whether new therapies can be added to standard chemotherapy or whether they may replace certain components of standard chemotherapy in the neoadjuvant setting. Therapies that are found effective can move onto a more focused Phase III registration trial. The talazoparib arm of the I-SPY 2 TRIAL will enroll up to 75 patients with HER-2 negative breast cancer. Patients will be treated initially with talazoparib daily and irinotecan every two weeks for 12 weeks followed by treatment with doxorubicin and cyclophosphamide. Patients in the comparator arm will receive standard paclitaxel therapy followed by doxorubicin and cyclophosphamide treatment. The primary endpoint of the trial is pathologic complete response (pCR), defined as the absence of clinical and pathological evidence of invasive tumor in breast or lymph nodes.
