Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
KU-0059436 · 7 trials · 12 indications
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease from baseline in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| Arm | Type | Description |
|---|---|---|
| KU-0059436 (AZD2281) 100 mg BID | EXPERIMENTAL | - |
| KU-0059436 (AZD2281) 400 mg BID | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | Gemcitabine + KU-0059436 |
| 2. | EXPERIMENTAL | Paclitaxel + KU-0059436 |
| 3. | EXPERIMENTAL | Paclitaxel, Carboplatin + KU-0059436 |
| KU-0059436 | EXPERIMENTAL | KU-0059436 administered orally twice daily |
| Name | Type | Description |
|---|---|---|
| KU-0059436 (AZD2281)(PARP inhibitor) | DRUG | oral |
| Gemcitabine | DRUG | intravenous injection |
| Topotecan | DRUG | intravenous infusion |
| Carboplatin | DRUG | intravenous injection |
| Paclitaxel | DRUG | Intravenous injection |
| Paclitaxel + Carboplatin | DRUG | Intravenous injection |
| dacarbazine | DRUG | intravenous injection over at least 20 minutes |
Inclusion Criteria: * Advanced ovarian cancer with positive BRCA1 or BRCA2 status * Failed at least one prior chemotherapy * In investigators opinion, no curative standard therapy exists * Measurable disease Exclusion Criteria: * Brain metastases * Less than 28 days since last treatment used to t...
KU-0059436 is an investigational small molecule being studied for the treatment of ovarian neoplasms, triple negative metastatic breast cancer, melanoma neoplasms, pancreatic neoplasms, and advanced solid malignancies. It is developed by AstraZeneca PLC (AZN) and is currently in Phase 1 clinical development.
KU-0059436 targets poly ADP-ribose polymerase (PARP), an enzyme involved in DNA repair. By inhibiting PARP, the drug aims to exploit DNA repair deficiencies in cancer cells, potentially leading to cell death. This mechanism is being evaluated in clinical trials for various solid tumors.
KU-0059436 is developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker AZN. The drug is currently in Phase 1 clinical trials for oncology indications.
KU-0059436 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to assess its safety, tolerability, and pharmacokinetics in patients with advanced solid malignancies.
KU-0059436 has been studied in several completed clinical trials, including NCT00494442 for BRCA-positive advanced ovarian cancer, NCT00516373 for ovarian neoplasms, NCT00516438 for malignant solid tumors in combination with topotecan, and NCT00516802 for melanoma neoplasms in combination with dacarbazine.
KU-0059436 is an alternative name for olaparib, a PARP inhibitor developed by AstraZeneca. It has been studied under the name KU-0059436 in early clinical trials for various cancers, including ovarian and breast cancer.