Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Adavosertib · 3 trials · 3 indications
Per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 for target lesions (TLs) and assessed by computed tomography (CT) or magnetic resonance imaging (MRI): Complete response (CR), Disappearance of all target lesions; Partial response (PR), \>=30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters.
Investigate the safety and tolerability of adavosertib
Investigate the safety and tolerability of adavosertib
| Arm | Type | Description |
|---|---|---|
| Adavosertib | EXPERIMENTAL | Subjects will receive adavosertib 300 mg administered orally, once daily on Days 1 to 5 and Days 8 to 12 of a 21-day treatment cycle. |
| Arm A (adavosertib + gemcitabine) | EXPERIMENTAL | Adavosertib (175 mg PO) will be taken on Days 1-2, 8-9, and 15-16. Gemcitabine 800 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle. |
| Arm B (adavosertib + paclitaxel) | EXPERIMENTAL | Five doses of adavosertib (225 mg PO BID) will be taken in approximate 12 hour intervals over 2.5 days weekly (Days 1-3, 8-10, and 15-17). Weekly paclitaxel 80 mg/m² IV will be administered according to institutional standards on Day 1, 8, and 15 of each 28 day cycle. |
| Arm C/C2 (adavosertib + carboplatin) | EXPERIMENTAL | Arm C: Five doses of adavosertib (225 mg PO BID) will be taken in approximate 12 hour intervals over 2.5 days (Days 1-3). Carboplatin AUC 5 IV will be administered according to institutional standards on Day 1 of each 21-Day cycle. Arm C2: Five doses of adavosertib (225 mg PO BID) 2.5 days per dosing week (QW), on Weeks 1 (D1-3), 2 (D8-10) and 3 (D15-17), or on Weeks 1 (D1-3) and 2 (D8-10) ( 2 weeks on followed by 1 week off.) Carboplatin AUC 5 IV will be administered according to institutional standards on Day 1 of each 21 day cycle. |
| Arm D (adavosertib + PLD) | EXPERIMENTAL | Five doses of adavosertib (175 mg or 225 mg) will be taken in approximate 12 hour intervals over 2.5 days (Days 1, 2, and 3) of each 28-day cycle. PLD will administered IV on Day 1 of each cycle. |
| Adavosertib (AZD1775) monotherapy | EXPERIMENTAL | Dose escalation of adavosertib monotherapy for patients with advanced solid tumours |
| Adavosertib (AZD1775) in combination with gemcitabine | EXPERIMENTAL | Dose escalation of adavosertib in combination with gemcitabine for patients with advanced solid tumours |
| Name | Type | Description |
|---|---|---|
| Adavosertib | DRUG | The subjects will receive oral adavosertib 300 mg, once daily on Days 1 to 5 and Days 8 to 12 of a 21-day treatment cycle. |
| Paclitaxel | DRUG | Paclitaxel will be administered as a 1-hour IV infusion (± 10 minutes) at a dose of 80 mg/m2 according to institutional standards on Days 1, 8, and 15 of each 28 Day cycle. Patients should be pre-medicated with corticosteroids, diphenhydramine and/or H2 antagonists according to institutional standards. |
| Carboplatin | DRUG | Carboplatin, at a dose calculated to produce an AUC of 5 will be administered by intravenous infusion according to institutional standards on Day 1 of each 21 Day cycle. The carboplatin dose will be calculated using the Calvert Formula based on the patient's glomerular filtration rate (GFR) which is estimated by using the creatinine clearance. |
| Gemcitabine | DRUG | Gemcitabine 800 mg/m² will be administered IV on Days 1, 8, and 15 of each 28-Day cycle. |
| PLD | DRUG | PLD (pegylated liposomal doxorubicin) 40 mg/m² IV will be given on Day 1 of each 28-Day cycle. |
| Adavosertib (AZD1775) | DRUG | Adavosertib taken orally |
Inclusion Criteria: 1. Subjects must be aged ≥ 18 years of age inclusive, at the time of signing the informed consent. 2. Histologically confirmed recurrent or persistent USC. Subjects with carcinosarcomas are not eligible. 3. Evidence of measurable disease as per RECIST v1.1. 4. At least 1 prior p...
Adavosertib is an investigational small molecule being studied for the treatment of ovarian, fallopian tube, peritoneal cancer with P53 mutation, advanced solid tumours, and uterine serous carcinoma. It is being developed by AstraZeneca PLC (AZN) and is currently in Phase 1 clinical development.
Adavosertib is a small molecule that targets the WEE1 kinase, a key regulator of the cell cycle checkpoint. By inhibiting WEE1, it disrupts DNA damage repair mechanisms in cancer cells, potentially making them more susceptible to chemotherapy. This mechanism is being explored in several oncology indications.
Adavosertib is being developed by AstraZeneca PLC, a global biopharmaceutical company. AstraZeneca is conducting clinical trials to evaluate the safety and efficacy of Adavosertib in various cancer types, including ovarian cancer and uterine serous carcinoma.
Adavosertib is currently in Phase 1 clinical development. While some trials have been completed, the drug is still investigational and has not been approved by regulatory authorities. It is being studied for multiple oncology indications, including advanced solid tumours and uterine serous carcinoma.
Adavosertib has been studied in several clinical trials, including NCT02272790, a Phase 2 study in platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer; NCT04462952, a Phase 1 study in Japanese patients with advanced solid tumours; and NCT04590248, a Phase 2 study in uterine serous carcinoma. All trials are completed.
Yes, Adavosertib is also known as AZD1775. In clinical trials, it is sometimes referred to by this alternative name, such as in the study of Adavosertib (AZD1775) in Japanese patients with advanced solid tumours. Both names refer to the same investigational drug.