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

Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00487058
Collaborator
(none)
28
Enrollment
1
Location

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
28 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally Twice Per Week to Japanese Patients With Advanced Solid Tumors.
Study Start Date :
May 1, 2007
Actual Primary Completion Date :
Jun 1, 2008

Outcome Measures

Primary Outcome Measures

  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) []

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Saitama Prefecture Japan

Sponsors and Collaborators

  • Novartis

Investigators

  • Study Chair: Novartis, Novartis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00487058
Other Study ID Numbers:
  • CLBQ707A1103
First Posted:
Jun 15, 2007
Last Update Posted:
Nov 19, 2009
Last Verified:
Nov 1, 2009
Keywords provided by , ,
Gimatecan
topoisomerase I inhibitor
advanced solid tumors
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Nov 19, 2009