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

Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00420485
• Other study ID #: CLBQ707A2101
• Status: Completed
• Phase: Phase 1
• First received: January 8, 2007
• Last updated: April 17, 2013
• Start date: March 2006
• Est. completion date: November 2010

Study information

• Verified date: April 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Spanish Agency of MedicinesDenmark: Danish Medicines AgencyNetherlands: Medicines Evaluation Board (MEB)Norway: Norwegian Medicines AgencyCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Other known NCT identifiers

• NCT00462163

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• gimatecan

Locations

Country	Name	City	State
Canada	MD Anderson Cancer Center - Orlando	Toronto	Ontario
Canada	Novartis Investigative Site	Vancouver	British Columbia
Denmark	Novartis Investigative Site	Copenhagen
France	Novartis Investigative Site	Dijon Cedex
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Saint-Herblain Cedex
France	Novartis Investigative Site	Toulouse
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Tubingen
Netherlands	Novartis Investigative Site	Enschede
Norway	Novartis Investigative Site	Oslo
Spain	Novartis Investigative Site	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Canada,  Denmark,  France,  Germany,  Netherlands,  Norway,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of dose limiting toxicities in a 56-day treatment period		56 days	Yes
Secondary	safety and tolerability assessed by adverse events, serious adverse events		112 days	Yes
Secondary	pharmacokinetics of gimatecan and its metabolites(s)		91 days	Yes
Secondary	response rate assessed by anti-tumor activity		112 days	No
Secondary	investigate tumor-specific mutations		57 days	No
Secondary	Evaluate activity signal for both dose schedules at MTD in ovarian, endometrial, and SCLC		56 days	No