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

Phase 1CompletedNCT00420485

Novartis Pharmaceuticals120 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Solid Tumors

Interventions

gimatecanDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Novartis Investigative Site

Vancouver, British Columbia, Canada

MD Anderson Cancer Center - Orlando

Toronto, Ontario, Canada

Novartis Investigative Site

Copenhagen, Denmark

Outcomes

Primary Outcomes

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

Time frame: 56 days

Secondary Outcomes

safety and tolerability assessed by adverse events, serious adverse events

Time frame: 112 days

pharmacokinetics of gimatecan and its metabolites(s)

Time frame: 91 days

response rate assessed by anti-tumor activity

Time frame: 112 days

investigate tumor-specific mutations

Time frame: 57 days

Evaluate activity signal for both dose schedules at MTD in ovarian, endometrial, and SCLC

Time frame: 56 days

Data from ClinicalTrials.gov

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