NCT00420485

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2006

Longer than P75 for phase_1

Geographic Reach
7 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 11, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

April 19, 2013

Status Verified

April 1, 2013

Enrollment Period

4.7 years

First QC Date

January 8, 2007

Last Update Submit

April 17, 2013

Conditions

Solid Tumors

Keywords

Maximum Tolerated DoseSolid TumorsDose Limiting ToxicityTopoisomerase-1 Inhibitor

Outcome Measures

Primary Outcomes (1)

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

    56 days

Secondary Outcomes (5)

  • 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

Study Arms (2)

Daily times five schedule

EXPERIMENTAL
Drug: gimatecan

Continuous schedule, twice daily

EXPERIMENTAL
Drug: gimatecan

Interventions

gimatecanDRUG
Continuous schedule, twice dailyDaily times five schedule

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced or metastatic cancer
  • years and above

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Novartis Investigative Site

Vancouver, British Columbia, Canada

Location

MD Anderson Cancer Center - Orlando

Toronto, Ontario, M5G 2M9, Canada

Location

Novartis Investigative Site

Copenhagen, DK-2100, Denmark

Location

Novartis Investigative Site

Dijon, 21034, France

Location

Novartis Investigative Site

Paris, 75005, France

Location

Novartis Investigative Site

Saint-Herblain, 44805, France

Location

Novartis Investigative Site

Toulouse, 31052, France

Location

Novartis Investigative Site

Mainz, 55101, Germany

Location

Novartis Investigative Site

Tübingen, 72076, Germany

Location

Novartis Investigative Site

Enschede, Netherlands

Location

Novartis Investigative Site

Oslo, 310, Norway

Location

Novartis Investigative Site

Madrid, 28041, Spain

Location

MeSH Terms

Interventions

ST 1481

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2007

First Posted

January 11, 2007

Study Start

March 1, 2006

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

April 19, 2013

Record last verified: 2013-04

Locations

NO(1)ES(1)DK(1)FR(4)DE(2)NL(1)CA(2)