CompletedNCT00410358Updated Dec 19, 2020

A Dose Escalation of Gimatecan Administered Orally to Japanese Patients With Advanced Solid Tumor.

A Phase 1 interventional study of Gimatecan in Advanced Solid Tumors, sponsored by Novartis Pharmaceuticals. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2020-12-19.

Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 19
Allocation: Non-randomized
Ages: 20 Years and older
Sex: All

Study 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.

Conditions studied

Advanced Solid Tumors

Browse trials for

Neoplasms 9,365

Keywords

Gimatecan
topoisomerase I inhibitor
advanced solid tumors

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 19 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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.

Other protocol-defined inclusion/exclusion criteria may apply

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 19 participants (actual)

Study arms

Experimental
LBQ707
Drug: Gimatecan

Interventions

DrugGimatecan
Also known as: LBQ707

What researchers measure

Primary outcomes

Estimated Maximum Tolerated Dose of gimatecan
Time frame: 1.8 years

Secondary outcomes

Safety assessed by adverse events
Time frame: 1.8 years
Characterization of the pharmacokinetic profile of gimatecan
Time frame: 1.8 years
Anti-tumor activity assessed by RECIST
Time frame: 1.8 years

Study locations

1 site

Novartis Investigative Site
Chiba Prefecture, Japan

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00410358
Lead sponsor: Novartis Pharmaceuticals
Responsible party: Sponsor
First posted: Dec 12, 2006
Start date: Jun 2006
Primary completion: Feb 2008
Last update: Dec 19, 2020

Study contacts

Novartis Pharmaceuticals

study director · Novartis Pharmaceuticals

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Neoplasms→

Other studies from this sponsor