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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00420485
Recruitment Status : Completed
First Posted : January 11, 2007
Last Update Posted : April 19, 2013
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
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
Study Start Date : March 2006
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Arm Intervention/treatment
Experimental: Daily times five schedule Drug: gimatecan
Experimental: Continuous schedule, twice daily Drug: gimatecan

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

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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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 identifier (NCT number): 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

Responsible Party: Novartis Pharmaceuticals Identifier: NCT00420485     History of Changes
Obsolete Identifiers: NCT00462163
Other Study ID Numbers: CLBQ707A2101
First Posted: January 11, 2007    Key Record Dates
Last Update Posted: April 19, 2013
Last Verified: April 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