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

Phase 1

Completed

• Conditions: Solid Tumors
• Interventions: Drug: gimatecan

• Registration Number: NCT00420485
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2007-01-08
• Study First Submitted QC: 2007-01-08
• Study First Posted: 2007-01-11
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-17
• Last Update Posted: 2013-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Continuous schedule, twice daily	gimatecan	-
Daily times five schedule	gimatecan	-

Primary Outcome Measures

Name	Time	Method
Presence of dose limiting toxicities in a 56-day treatment period	56 days

Secondary Outcome Measures

Name	Time	Method
safety and tolerability assessed by adverse events, serious adverse events	112 days
pharmacokinetics of gimatecan and its metabolites(s)	91 days
response rate assessed by anti-tumor activity	112 days
investigate tumor-specific mutations	57 days
Evaluate activity signal for both dose schedules at MTD in ovarian, endometrial, and SCLC	56 days

Trial Locations

Locations (2)

Novartis Investigative Site; 🇪🇸 Madrid, Spain

MD Anderson Cancer Center - Orlando; 🇨🇦 Toronto, Ontario, Canada