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Dose-escalation Study of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00420485
First received: January 8, 2007
Last updated: April 17, 2013
Last verified: April 2013
History of Changes
  Purpose

This study will evaluate the Maximum Tolerated Dose and dose limiting toxicity of gimatecan administered orally in patients with advanced solid tumors


Condition Intervention Phase
Solid Tumors
 Drug: gimatecan
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Open-label, Multi-center Dose-escalation Study to Determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Presence of dose limiting toxicities in a 56-day treatment period [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • safety and tolerability assessed by adverse events, serious adverse events [ Time Frame: 112 days ] [ Designated as safety issue: Yes ]
  • pharmacokinetics of gimatecan and its metabolites(s) [ Time Frame: 91 days ] [ Designated as safety issue: Yes ]
  • response rate assessed by anti-tumor activity [ Time Frame: 112 days ] [ Designated as safety issue: No ]
  • investigate tumor-specific mutations [ Time Frame: 57 days ] [ Designated as safety issue: No ]
  • Evaluate activity signal for both dose schedules at MTD in ovarian, endometrial, and SCLC [ Time Frame: 56 days ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: March 2006
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Daily times five schedule Drug: gimatecan
Experimental: Continuous schedule, twice daily Drug: gimatecan

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Advanced or metastatic cancer
  • 18 years and above

Exclusion criteria:

  • Previous treatment with 4 or more cycles of carboplatin;
  • Previous treatment with 2 or more courses of nitrosourea or mitomycin;
  • Previous radiation therapy greater than or equal to 25% of the hematopoietic reserve;
  • Severe and/or uncontrolled medical conditions

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00420485

Locations
Canada, British Columbia
Novartis Investigative Site
Vancouver, British Columbia, Canada
Canada, Ontario
MD Anderson Cancer Center - Orlando
Toronto, Ontario, Canada, M5G 2M9
Denmark
Novartis Investigative Site
Copenhagen, Denmark, DK-2100
France
Novartis Investigative Site
Dijon Cedex, France, 21034
Novartis Investigative Site
Paris, France, 75005
Novartis Investigative Site
Saint-Herblain Cedex, France, 44805
Novartis Investigative Site
Toulouse, France, 31052
Germany
Novartis Investigative Site
Mainz, Germany, 55101
Novartis Investigative Site
Tubingen, Germany, 72076
Netherlands
Novartis Investigative Site
Enschede, Netherlands
Norway
Novartis Investigative Site
Oslo, Norway, 310
Spain
Novartis Investigative Site
Madrid, Spain, 28041
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00420485     History of Changes
Obsolete Identifiers: NCT00462163
Other Study ID Numbers: CLBQ707A2101
Study First Received: January 8, 2007
Last Updated: April 17, 2013
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Spanish Agency of Medicines
Denmark: Danish Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
Norway: Norwegian Medicines Agency
Canada: Health Canada

Keywords provided by Novartis:
Maximum Tolerated Dose
Solid Tumors
Dose Limiting Toxicity
Topoisomerase-1 Inhibitor

Additional relevant MeSH terms:
Neoplasms
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013