Clinical trial · Interventional
A Dose Escalation of Gimatecan Administered Orally to Japanese Patients With Advanced Solid Tumor.
A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor.
NCT00410358CI-TRIAL-00048970completedPhase 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 assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients. Gimatecan is administered orally for five consecutive days, every 28 days, to adult patients with advanced solid tumors who have progressed despite standard therapy or for whom standard systemic therapy does not exist.
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 |
|---|---|---|---|
| Gimatecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LBQ707
- interventionNames
- Drug: Gimatecan
Primary outcomes (1)
- measure
- Estimated Maximum Tolerated Dose of gimatecan
- timeFrame
- 1.8 years
Secondary outcomes (3)
- measure
- Safety assessed by adverse events
- timeFrame
- 1.8 years
- measure
- Characterization of the pharmacokinetic profile of gimatecan
- timeFrame
- 1.8 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histological or cytological confirmed advanced solid tumors, which have progressed despite standard therapy or for whom no standard therapy exists. * Life expectancy of at least 3 months * Adequate hematological parameters * No major impairment of renal and hepatic function Exclusion Criteria: * Gastrointestinal dysfunction, such as gastrectomy and malabsorption syndrome that could alter absorption. * Patients who have received any investigational compound within the past 28 days. * Patients with other antineoplastic therapy within the last 28 days. * Patients known to be HIV or hepatitis virus positive, or patients with the presence of active or suspected acute or chronic uncontrolled infection * Patients with a history of allergies to the camptothecin family drug. Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.