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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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: January 8, 2007
Last updated: April 17, 2013
Last verified: April 2013
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
Intervention Model: Single Group Assignment
Masking: None (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

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

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

Secondary Outcome Measures:
  • safety and tolerability assessed by adverse events, serious adverse events [ Time Frame: 112 days ]
  • pharmacokinetics of gimatecan and its metabolites(s) [ Time Frame: 91 days ]
  • response rate assessed by anti-tumor activity [ Time Frame: 112 days ]
  • investigate tumor-specific mutations [ Time Frame: 57 days ]
  • Evaluate activity signal for both dose schedules at MTD in ovarian, endometrial, and SCLC [ Time Frame: 56 days ]

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00420485

Canada, British Columbia
Novartis Investigative Site
Vancouver, British Columbia, Canada
Canada, Ontario
MD Anderson Cancer Center - Orlando
Toronto, Ontario, Canada, M5G 2M9
Novartis Investigative Site
Copenhagen, Denmark, DK-2100
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
Novartis Investigative Site
Mainz, Germany, 55101
Novartis Investigative Site
Tubingen, Germany, 72076
Novartis Investigative Site
Enschede, Netherlands
Novartis Investigative Site
Oslo, Norway, 310
Novartis Investigative Site
Madrid, Spain, 28041
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals Identifier: NCT00420485     History of Changes
Obsolete Identifiers: NCT00462163
Other Study ID Numbers: CLBQ707A2101
Study First Received: January 8, 2007
Last Updated: April 17, 2013

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

Additional relevant MeSH terms:
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017