Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors

Thank you

Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Presence of dose limiting toxicities in a 56-day treatment period

Outcome Time Frame:

56 days

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLBQ707A2101

NCT ID:

NCT00420485

Start Date:

March 2006

Completion Date:

November 2010

Related Keywords:

  • Solid Tumors
  • Maximum Tolerated Dose
  • Solid Tumors
  • Dose Limiting Toxicity
  • Topoisomerase-1 Inhibitor
  • Neoplasms

Name

Location