NCT00441610

Brief Summary

CLBQ707A1101 assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

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

January 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Last Updated

December 19, 2020

Status Verified

April 1, 2012

Enrollment Period

2.7 years

First QC Date

February 28, 2007

Last Update Submit

December 16, 2020

Conditions

Advanced Solid Tumors

Keywords

Gimatecantopoisomerase I inhibitoradvanced solid tumors

Outcome Measures

Primary Outcomes (2)

  • Safety and tolerability assessed by Adverse Events

    2.8 years

  • Anti-tumor activity assessed by RECIST criteria

    2.8 years

Study Arms (1)

Gimatecan

EXPERIMENTAL
Drug: Gimatecan

Interventions

GimatecanDRUG
Also known as: LBQ707
Gimatecan

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients completing the core protocol (CLBQ707A1101, NCT00410358) exhibiting stable disease, or a partial or complete response as defined by the core protocol. If patients only have non-measurable lesions, he/she must not be exhibiting progressive disease

You may not qualify if:

  • Documented progressive disease as defined by the core protocol
  • Patients with performance status of 3 or 4 on the ECOG scale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Chiba, Japan

Location

Related Links

MeSH Terms

Interventions

ST 1481

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 28, 2007

First Posted

March 1, 2007

Study Start

January 1, 2007

Primary Completion

September 1, 2009

Last Updated

December 19, 2020

Record last verified: 2012-04

Locations

JP(1)