NCT00487058CompletedPhase 1
A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally Twice Per Week to Japanese Patients With Advanced Solid Tumors.
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Safety and tolerability assessed by Adverse Events Characterization of the pharmacokinetic profile of gimatecan Anti-tumor activity assessed by Response Evaluation Criteria in Solid Tumors RECIST)
Study Overview
Brief Summary
This study assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients. Gimatecan is administered orally twice per week, every 28 days, to adult patients with advanced solid tumors who have progressed despite standard therapy or for whom standard systemic therapy dose not exist.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with histological or cytological confirmed advanced solid tumors, which progressed despite standard therapy or for whom no standard therapy exists
- •Life expectancy of at least 3 months
- •No dysfunction of bone marrow
- •No major impairment of renal and hepatic function
Exclusion Criteria
- •Gastrointestinal dysfunction, such as gastrectomy or malabsorption syndrome, that could alter absorption of the study drug
- •Receipt of any investigational compound within the 28 days prior to the first dose of study drug, or failure to recover from the side effects of such prior therapy
- •Receipt of other antineoplastic therapy including chemotherapy, hormone therapy, immunotherapy, radiation therapy within the 28 days
- •Patients known to be HIV, or hepatitis B or C viruses 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 of drugs
- •Other protocol-defined inclusion/exclusion criteria may apply
Outcomes
Primary Outcomes
Safety and tolerability assessed by Adverse Events Characterization of the pharmacokinetic profile of gimatecan Anti-tumor activity assessed by Response Evaluation Criteria in Solid Tumors RECIST)
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
A Dose Escalation of Gimatecan Administered Orally to Japanese Patients With Advanced Solid Tumor.Advanced Solid TumorsNCT00410358Novartis Pharmaceuticals19
Completed
Phase 1
An Extension Trial to a Phase I Dose Escalation Study of Gimatecan Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid TumorAdvanced Solid TumorsNCT00441610Novartis Pharmaceuticals4
Unknown
Phase 1
A Clinical Study of Gimatecan in Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer or Primary Peritoneal CancerOvarian Epithelial CancerFallopian Tube CancerPrimary Peritoneal CancerNCT04029909Lee's Pharmaceutical Limited12
Completed
Phase 1
Dose-escalation Study of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid TumorsSolid TumorsNCT00420485Novartis Pharmaceuticals120
Completed
Phase 1
A Study of the Pharmacokinetics of Golimumab in Japanese and Caucasian Male SubjectsHealthy VolunteersNCT01258777Centocor, Inc.49