A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally Twice Per Week to Japanese Patients With Advanced Solid Tumors

NCT00487058 | Completed Phase 1

• 1 other identifier: CLBQ707A1103
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Keywords

Gimatecan; topoisomerase I inhibitor; advanced solid tumors

Outcome Measures

Primary Outcomes (1)

• 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)

Interventions

Gimatecan DRUG

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Unknown Facility

Saitama Prefecture, Japan

Location

MeSH Terms

Interventions

ST 1481

Study Officials

• Novartis

  Novartis

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 14, 2007
• First Posted: June 15, 2007
• Study Start: May 1, 2007
• Primary Completion: June 1, 2008
• Last Updated: November 19, 2009

Record last verified: 2009-11

Locations

JP (1)