NCT00410358

Brief Summary

This study assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients. Gimatecan is administered orally for five consecutive days, every 28 days, to adult patients with advanced solid tumors who have progressed despite standard therapy or for whom standard systemic therapy does not exist.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at P25-P50 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

June 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Last Updated

December 19, 2020

Status Verified

October 1, 2012

Enrollment Period

1.7 years

First QC Date

December 11, 2006

Last Update Submit

December 16, 2020

Conditions

Advanced Solid Tumors

Keywords

Gimatecantopoisomerase I inhibitoradvanced solid tumors

Outcome Measures

Primary Outcomes (1)

  • Estimated Maximum Tolerated Dose of gimatecan

    1.8 years

Secondary Outcomes (3)

  • Safety assessed by adverse events

    1.8 years

  • Characterization of the pharmacokinetic profile of gimatecan

    1.8 years

  • Anti-tumor activity assessed by RECIST

    1.8 years

Study Arms (1)

LBQ707

EXPERIMENTAL
Drug: Gimatecan

Interventions

GimatecanDRUG
Also known as: LBQ707
LBQ707

Eligibility Criteria

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

You may qualify if:

  • Patients with histological or cytological confirmed advanced solid tumors, which have progressed despite standard therapy or for whom no standard therapy exists.
  • Life expectancy of at least 3 months
  • Adequate hematological parameters
  • No major impairment of renal and hepatic function

You may not qualify if:

  • Gastrointestinal dysfunction, such as gastrectomy and malabsorption syndrome that could alter absorption.
  • Patients who have received any investigational compound within the past 28 days.
  • Patients with other antineoplastic therapy within the last 28 days.
  • Patients known to be HIV or hepatitis virus positive, or patients with the presence of active or suspected acute or chronic uncontrolled infection
  • Patients with a history of allergies to the camptothecin family drug.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Chiba Prefecture, 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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2006

First Posted

December 12, 2006

Study Start

June 1, 2006

Primary Completion

February 1, 2008

Last Updated

December 19, 2020

Record last verified: 2012-10

Locations

JP(1)