Clinical trial · Interventional
Study to Assess the Safety and Tolerability of the Tor Kinase Inhibitor AZD8055
A Phase I, Open Label, Single-centre Study to Assess the Safety and Tolerability of the Tor Kinase Inhibitor AZD8055 Administered Orally to Japanese Patients With Advanced Solid Tumours
NCT00973076CI-TRIAL-00005023completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective is to assess the safety and tolerability of AZD8055 in Japanese patients with advanced solid tumours.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AZD8055 | Drug | MTOR Kinase Inhibitor AZD8055 | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AZD8055
- description
- AZD8055 will be administered orally
- interventionNames
- Drug: AZD8055
Primary outcomes (1)
- measure
- Assessment of adverse events, clinical laboratory tests (clinical chemistry, haematology, coagulation, urinalysis), glucose management (s-glucose, s-insulin, haemoglobin A1c [HbA1c]), vital signs (pulse rate, blood pressure, weight and body temperature)
- timeFrame
- Laboratory values, vital sign, physical examination every week during Cycle 1 and 2.
Secondary outcomes (2)
- measure
- To determine the pharmacokinetic profile of AZD8055 following both single and multiple oral dosing in patients with advanced solid tumours
- timeFrame
- According to protocol specified schedule, the number of PK samples collected during Cycle 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Japanese patients with advanced solid tumors for which suitable effective standard treatment does not exist or is no longer effective * Relatively good overall health other than cancer Exclusion Criteria: * Poor bone marrow function (not producing enough blood cells) * Poor liver or kidney function * Serious concomitant illness
References
Publications (1)
- DERIVEDAsahina H, Nokihara H, Yamamoto N, Yamada Y, Tamura Y, Honda K, Seki Y, Tanabe Y, Shimada H, Shi X, Tamura T. Safety and tolerability of AZD8055 in Japanese patients with advanced solid tumors; a dose-finding phase I study. Invest New Drugs. 2013 Jun;31(3):677-84. doi: 10.1007/s10637-012-9860-4. Epub 2012 Jul 28. PMID 22843211