Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03907969 | A Clinical Trial to Evaluate AZD7648 Alone and in Combination With Other Anti-cancer Agents in Patients With Advanced Cancers. | PHASE1 | COMPLETED | 30 | — | — | Oct 9, 2019 | Dec 7, 2022 | Feb 6, 2024 | 5 | United States, United Kingdom |
Safety and tolerability of AZD7648 when given orally to patients with advanced malignancies, as monotherapy and in combination with anti-cancer agents was assessed.
A DLT is defined as an AE that occurs from the first dose of study treatment up to and including Cycle 1, Day 28 (the DLT assessment period) that is assessed as unrelated to the disease, intercurrent illness, or concomitant medications.
| Arm | Type | Description |
|---|---|---|
| Core Module: AZD7648 Monotherapy | EXPERIMENTAL | AZD7648 will be administered orally on an empty stomach |
| Combination Module 1: AZD7648 + PLD | EXPERIMENTAL | AZD7648 will be administered in combination with Pegylated liposomal doxorubicin (PLD) |
| Name | Type | Description |
|---|---|---|
| AZD7648 | DRUG | Core: AZD7648 will be administered orally |
| PLD | DRUG | The starting dose of PLD is 40 mg/m\^2, administered by intravenous infusion once every 4 weeks, for a maximum of 6 cycles |
Inclusion Criteria: 1. Capable and willing to give signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF). 2. Participant must be at least 18 years of age, at the time of signing the ICF. 3. Participants must have histologi...