Clinical trial · Interventional
Dose Escalation of HSP990 in Japan/Korea
A Phase I Dose Escalation, Multi-center, Open-label Study of HSP990 Administered Orally Once Weekly in Adult Japanese and Korea Patients With Advanced Solid Malignancies
NCT01064089CI-TRIAL-00048669terminatedPhase 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 study is a phase I dose escalation, multi-center, open-label study of HSP990 administered orally once weekly in adult Japanese and Korea 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 |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HSP990 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HSP990
- description
- dose escalation
- interventionNames
- Drug: HSP990
Primary outcomes (1)
- measure
- establish maximum tolerated dose (MTD)
- timeFrame
- 2.5 years
Secondary outcomes (4)
- measure
- Safety by measuring occurrence of dose limiting toxicity (DLT) and other adverse events
- timeFrame
- 2.5 years
- measure
- Efficacy by collecting data on response (complete response [CR], partial response [PR]) and stable disease (SD)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with advanced solid tumors (advanced cancer) 2. Patient's disease must be evaluable using the RECIST criteria 3. Patients must be 18 or older in Korea or 20 or older in Japan 4. Patients must be relatively healthy as measured by their performance status 5. Patients must have acceptable laboratory values as measured by blood tests 6. Patients must be able to swallow capsules 7. Patients must understand the study and give written permission to enter study Exclusion Criteria: 1. Patients cannot have brain tumors 2. Patients cannot have had prior medicines that are similar to the study drug or an HDAC inhibitor medicine 3. Patients must not be classified as a "poor or intermediate CYP2C9 metabolizer" as measured using a sample of their blood 4. Patients must have recovered from all previous anti-cancer therapy 5. Patients must have finished taking their previous anti-cancer therapy before entering study 6. Patients must not have a severe disease at the time of study entry (for example: severe diarrhea, disease of the liver or kidney, other cancers, etc.) 7. Patients must have relatively good heart function Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.