Clinical trial · Interventional
Safety and Tolerability Study of AZD7762 in Combination With Gemcitabine
A Phase I, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability & Pharmacokinetics of AZD7762 Administered as a Single Intravenous Agent and in Combination w/ Wkly Standard Dose Gemcitabine in Japanese Patients w/ Advanced Solid Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Termination of the study was made after a full review of program data and assessment of the current risk-benefit profile.
Summary
Brief summary (as posted)
The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD7762 when given with the approved drug gemcitabine based on the side effects experienced by patients that receive both drugs.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Malignancies | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AZD7762 | Drug | Checkpoint Kinase Inhibitor AZD7762 | ALIAS |
| gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- AZD7762 + gemcitabine
- description
- AZD7762 administered alone and in combination with gemcitabine
- interventionNames
- Drug: AZD7762
- Drug: gemcitabine
Primary outcomes (1)
- measure
- Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, cardiac markers, ECG, Echocardiogram
- timeFrame
- Laboratory values weekly for all treatment cycles, and the other variables weekly for Cycle 0-1, then every cycle (3-4 weeks) from Cycle 2
Secondary outcomes (2)
- measure
- Pharmacokinetic effect of AZD7762 when administered alone and in combination with gemcitabine
- timeFrame
- According to protocol specified schedule, the number of PK samples collected during Cycle 0 and Cycle 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Japanese patients with advanced solid tumors for which standard treatment does not exist or is no longer effective. * Must be suitable for treatment with gemcitabine * Relatively good overall health other than cancer Exclusion Criteria: * Poor bone marrow function (not producing enough blood cells). * Poor liver or kidney function. * Serious heart conditions
References
Publications (0)
Data not yet available