Table 6.
Ongoing or future PARP inhibitor trials in sporadic breast and ovarian cancers.
| Trial | Study population | PARP inhibitor | Comparison therapy | ClinicalTrials.gov status |
|---|---|---|---|---|
| Phase III | PSens BRCAutmut or HGS OC w/prior CR and second CR/PR | Niraparib (maintenance) | Placebo | NCT01847274 |
| Recruiting | ||||
| Phase I | Recur TNBC/HGS OC | Olaparib + BKM120 (PI3 kinase inhibitor) | None | NCT01623349 |
| Recruiting | ||||
| Phase I | Met or unresect TNBC/serous EOC | Olaparib + carboplatin | None | NCT01445418 |
| Recruiting | ||||
| Phase I/Ib | Relapsed stage III or IV OC | Olaparib + carboplatin and paclitaxel | None | NCT01650376 |
| Recruiting | ||||
| Phase II | Relapsed recur PSens high-grade EOC | Rucaparib | None | NCT01891344 (ARIEL2) |
| Recruiting | ||||
| Phase II Miller et al. (105) | BRCAutmut BC or BRCAtwt TNBC w/residual disease in adjuvant setting (after NAC/surgery) | Rucaparib + cisplatin | Cisplatin | NCT01074970 Ongoing, not recruiting |
| Phase I | Recur or residual EOC/met TNBC | Veliparib | Pegylated liposomal doxorubicin | NCT01145430 |
| Pothuri et al. (108) | Recruiting | |||
| Phase I | Recur met or locally advanced unresect solid tumors (e.g., BC/OCs) with organ dysfunction | Veliparib | Carboplatin and paclitaxel | NCT01366144 Recruiting |
| Phase I | Recur OC | Veliparib | None | NCT01459380 |
| Two arms + doxorubicin, carboplatin, and bevacizumab | Recruiting | |||
| Phase I | Node-positive BC with incomplete response to NAC | Veliparib | Radiation therapy | NCT01618357 |
| Recruiting | ||||
| Phase I | Recur stage IV EOC | Veliparib + intraperitoneal floxuridine (FUDR) | None | NCT01749397 |
| Recruiting | ||||
| Phase I | Newly diagnosed stage II–IV optimally or suboptimally debulked OC | Veliparib + paclitaxel, carboplatin, bevacizumab | None | NCT00989651 Recruiting |
| Two parallel arms | ||||
| Phase II | Stage IIA, IIIA–C TNBC | Veliparib + paclitaxel + carboplatin, followed by doxorubicin, cyclophosphamide (neoadjuvant) | Paclitaxel, carboplatin, followed by doxorubicin, cyclophosphamide | NCT01818063 |
| Avery et al. (109) | Recruiting | |||
| Phase II | Recur HGS OC | Veliparib + temozolomide | Pegylated liposomal doxorubicin | NCT01113957 |
| Completed | ||||
| Phase I/II | Recurrent, relapsed PRes or part PSens OC | Veliparib + topotecan | None | NCT01690598 |
| Recruiting | ||||
| Phase II | Recur advanced non-PSens OC | Veliparib + topotecan | None | NCT01012817 |
| Recruiting |
PSen, platinum-sensitive; BRCAmut, BRCA 1/2-mutated; HGS, high-grade serous; OC, ovarian cancer; CR, complete response; PR, partial response; recur, recurrent; TNBC, triple negative breast cancer; met, metastatic; unresect, unresectable; EOC, epithelial ovarian cancer; BC, breast cancer; BRCAwt, BRCA-wild type; NAC, neoadjuvant chemotherapy; PRes, platinum-resistant.