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A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor.


Phase 1
20 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors

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Trial Information

A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor.


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:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Estimated Maximum Tolerated Dose of gimatecan

Outcome Time Frame:

1.8 years

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

CLBQ707A1101

NCT ID:

NCT00410358

Start Date:

June 2006

Completion Date:

Related Keywords:

  • Advanced Solid Tumors
  • Gimatecan
  • topoisomerase I inhibitor
  • advanced solid tumors
  • Neoplasms

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