Clinical trial · Interventional
Phase I Study to Determine the Maximum Tolerate Dose (MTD) of BGT226 in Advanced Solid Tumors in Japan
A Phase I Study of BGT226, Administered Orally in Adult Patients With Advanced Solid Tumor in Japan
NCT00742105CI-TRIAL-00035021terminatedPhase 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 will confirm safety and tolerability and determine the MTD of BGT226 in Japanese patients with advanced solid tumor.
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 Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BGT226 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BGT226
- interventionNames
- Drug: BGT226
Primary outcomes (1)
- measure
- Incidence of dose limiting toxicity (DLT) at each dose level
- timeFrame
- 22-28 days
Secondary outcomes (4)
- measure
- Safety measured by type, frequency and severity of adverse drug reactions
- timeFrame
- Every 4 weeks
- description
- Safety measures by Common Terminology Criteria for Adverse Events (CTCAE)
- measure
- Preliminary Efficacy od BGT226
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * World Health Organization (WHO) Performance Status of ≤ 2 * Histologically-confirmed, advanced solid tumors * Progressive, recurrent unresectable disease * Age ≥ 20 Exclusion Criteria: * Hematopoietic: * No diabetes mellitus or history of gestational diabetes mellitus * No acute or chronic renal disease * No acute or chronic liver disease * No acute or chronic pancreatitis * No impaired cardiac function or clinically significant cardiac diseases such as ventricular arrhythmia, congestive heart failure, uncontrolled hypertension * No acute myocardial infarction or unstable angina pectoris within the past 3 months * Not pregnant or nursing and fertile patients must use barrier contraceptives Other protocol-defined inclusion/exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.