Clinical trial · Interventional
Study of Adavosertib(AZD1775) in Japanese Patients With Advanced Solid Tumours
A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-Tumour Activity of Adavosertib (AZD1775) in Monotherapy and in Combination With Chemotherapy in Japanese Patients With Advanced Solid Tumours
NCT04462952CI-TRIAL-00059864completedPhase 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)
This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics(PK) and anti-tumour activity of adavosertib in Japanese patients with advanced solid tumours. This study consists of 2 parts, monotherapy (part A) and chemotherapy combination (part B). At least 3, or up to 6, evaluable Japanese patients with advanced solid tumours will be enrolled in each cohort to confirm the tolerability.
Conditions
Conditions (1)
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 Tumours | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adavosertib (AZD1775) | Drug | Adavosertib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Adavosertib (AZD1775) monotherapy
- description
- Dose escalation of adavosertib monotherapy for patients with advanced solid tumours
- interventionNames
- Drug: Adavosertib (AZD1775)
- type
- EXPERIMENTAL
- label
- Adavosertib (AZD1775) in combination with gemcitabine
- description
- Dose escalation of adavosertib in combination with gemcitabine for patients with advanced solid tumours
- interventionNames
- Drug: Adavosertib (AZD1775)
Primary outcomes (2)
- measure
- Incidence of Adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Major Inclusion Criteria: * Japanese patients ≥20 years of age at the time of study entry * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0, 1 * Adequate bone marrow reserve or organ function * Female patients who are not of child-bearing potential, and fertile females of childbearing potential who agree to use adequate contraceptive measures * Male patients should be willing to use barrier contraception * Predicted life expectancy ≥12 weeks * Part A : Histologically or cytologically documented locally advanced or metastatic solid tumour, excluding lymphoma, for which standard therapy does not exist or has proven ineffective or intolerable * Part B : Histologically or cytologically documented locally advanced or metastatic solid tumour, excluding lymphoma, for which standard therapy does not exist or has proven ineffective or intolerable and additionally, tumours for which gemcitabine is expected to be effective. * Measurable or non-measurable disease according to RECIST v1.1 Major Exclusion Criteria: * Use of anti-cancer treatment drug ≤21 days or 5 half-lives (whichever is shorter) prior to Cycle 1 Day 1 * Use of an investigational drug during the past 30 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1 * Common Terminology Criteria for Adverse Events (CTCAE) Grade \>1 toxicity from prior therapy * Inability to swallow oral medication or any other condition that may impact adavosertib intake/absorption * Known malignant central nervous system (CNS) disease other than neurologically stable, treated brain metastases * Any of the cardiac diseases currently or within the last 6 months * Any underlying medical condition that would impair the patient's ability to receive study treatment * Other invasive malignancy within 5 years prior to Cycle 1 Day 1 except for non-invasive malignancies * Part B : Presence of apparent radiological findings for interstitial pneumonitis or pulmonary fibrosis with pulmonary symptoms
References
Publications (1)
- DERIVEDKondo S, Katsuya Y, Yonemori K, Komuro K, Sugeno M, Kawata T, Ghiorghiu D, Meulendijks D, Yamamoto N. Safety, tolerability, pharmacokinetics, and antitumor activity of adavosertib in Japanese patients with advanced solid tumors: A phase I, open-label study. Cancer Treat Res Commun. 2024;39:100809. doi: 10.1016/j.ctarc.2024.100809. Epub 2024 Mar 24. PMID 38593512