Clinical trial · Interventional
A Study of ZSTK474 in Japanese Patients With Advanced Solid Malignancies
A Phase 1, Multi-Center, Open Label, Uncontrolled, Serial Cohort, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of ZSTK474 in Japanese Patients With Advanced Solid Malignancies
NCT01682473CI-TRIAL-00028504completedPhase 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)
To evaluate the safety (adverse events and dose-limiting toxicity) of daily oral doses of ZSTK474 in patients with advanced solid malignancies.
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 |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ZSTK474 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1: 5/2 Dosing
- description
- Subjects will receive oral ZSTK474 at a fixed once daily dose administered in 4-week (28-day) cycles of 5 days on drug and 2 days off drug.
- interventionNames
- Drug: ZSTK474
- type
- EXPERIMENTAL
- label
- Arm 2: 21/7 Dosing
- description
- Subjects will receive oral ZSTK474 at a fixed once daily dose administered in 4-week (28-day) cycles of 21 days on drug and 7 days off drug.
- interventionNames
- Drug: ZSTK474
Primary outcomes (1)
- measure
- Number of participants with dose-limiting toxicities
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Japanese males or females \>= 20 years old * Advanced (metastatic or unresectable) solid tumor * ECOG performance status score of 0 or 1 and expected survival \>12 weeks * Recovered from hematological toxicities of prior cancer therapies Exclusion Criteria: * Previous treatment with PI3K inhibitor * Serious/significant illnesses or underlying conditions, including diabetes or hepatic renal or CV disease. * Other investigational agent within previous 4 weeks * Participating in another clinical study
References
Publications (0)
Data not yet available
No reference posted for this study.