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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

January 8, 2007
April 17, 2013
March 2006
November 2010   (final data collection date for primary outcome measure)
Presence of dose limiting toxicities in a 56-day treatment period [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]
Presence of dose limiting toxicities in a 56-day treatment period
Complete list of historical versions of study NCT00420485 on ClinicalTrials.gov Archive Site
  • 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 ]
  • safety and tolerability assessed by adverse events, serious adverse events
  • pharmacokinetics of gimatecan and its metabolites(s)
  • response rate assessed by anti-tumor activity
  • investigate tumor-specific mutations
  • investigate circulating tumor cells and markers of apoptosis
Not Provided
Not Provided
 
Dose-escalation Study of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumors
Drug: gimatecan
  • Experimental: Daily times five schedule
    Intervention: Drug: gimatecan
  • Experimental: Continuous schedule, twice daily
    Intervention: Drug: gimatecan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
November 2010
November 2010   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Denmark,   France,   Germany,   Netherlands,   Norway,   Spain
 
NCT00420485
CLBQ707A2101
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP