Dose-Escalation Study of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00420485

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

Drug Information available for: Gimatecan

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 ]

Estimated Enrollment:	119
Study Start Date:	February 2006
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Daily times five schedule: Experimental	Drug: gimatecan
Continuous schedule, twice daily: Experimental	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
Toulouse, France, 31052
Novartis Investigative Site
Dijon Cedex, France, 21034
Novartis Investigative Site
Saint-Herblain Cedex, France, 44805
Novartis Investigative Site
Paris, France, 75005
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

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CLBQ707A2101
Study First Received:	January 8, 2007
Last Updated:	March 11, 2009
ClinicalTrials.gov Identifier:	NCT00420485 History of Changes
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; France: Afssaps - French Health Products Safety Agency; 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

ClinicalTrials.gov processed this record on September 09, 2009