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An Extension Trial to a Phase I Dose Escalation Study of Gimatecan Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor

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ClinicalTrials.gov Identifier: NCT00441610
Recruitment Status : Completed
First Posted : March 1, 2007
Last Update Posted : May 1, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
CLBQ707A1101 assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: Gimatecan Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Extension Trial to a Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor
Study Start Date : January 2007
Actual Primary Completion Date : September 2009

Arm Intervention/treatment
Experimental: Gimatecan Drug: Gimatecan
Other Name: LBQ707




Primary Outcome Measures :
  1. Safety and tolerability assessed by Adverse Events [ Time Frame: 2.8 years ]
  2. Anti-tumor activity assessed by RECIST criteria [ Time Frame: 2.8 years ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients completing the core protocol (CLBQ707A1101, NCT00410358) exhibiting stable disease, or a partial or complete response as defined by the core protocol. If patients only have non-measurable lesions, he/she must not be exhibiting progressive disease

Exclusion criteria:

  • Documented progressive disease as defined by the core protocol
  • Patients with performance status of 3 or 4 on the ECOG scale

Other protocol-defined inclusion/exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00441610


Locations
Japan
Novartis Investigative Site
Chiba, Japan
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00441610     History of Changes
Other Study ID Numbers: CLBQ707A1101E1
First Posted: March 1, 2007    Key Record Dates
Last Update Posted: May 1, 2012
Last Verified: April 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Gimatecan
topoisomerase I inhibitor
advanced solid tumors

Additional relevant MeSH terms:
Camptothecin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action