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A Phase I Dose Escalation, Multi-center, Open-label Study of HSP990 Administered Orally Once Weekly in Adult Japanese and Korea Patients With Advanced Solid Malignancies


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

Thank you

Trial Information

A Phase I Dose Escalation, Multi-center, Open-label Study of HSP990 Administered Orally Once Weekly in Adult Japanese and Korea Patients With Advanced Solid Malignancies


Inclusion Criteria:



1. Patients with advanced solid tumors (advanced cancer)

2. Patient's disease must be evaluable using the RECIST criteria

3. Patients must be 18 or older in Korea or 20 or older in Japan

4. Patients must be relatively healthy as measured by their performance status

5. Patients must have acceptable laboratory values as measured by blood tests

6. Patients must be able to swallow capsules

7. Patients must understand the study and give written permission to enter study

Exclusion Criteria:

1. Patients cannot have brain tumors

2. Patients cannot have had prior medicines that are similar to the study drug or an
HDAC inhibitor medicine

3. Patients must not be classified as a "poor or intermediate CYP2C9 metabolizer" as
measured using a sample of their blood

4. Patients must have recovered from all previous anti-cancer therapy

5. Patients must have finished taking their previous anti-cancer therapy before entering
study

6. Patients must not have a severe disease at the time of study entry (for example:
severe diarrhea, disease of the liver or kidney, other cancers, etc.)

7. Patients must have relatively good heart function

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

establish maximum tolerated dose (MTD)

Outcome Time Frame:

2.5 years

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CHSP990A1101

NCT ID:

NCT01064089

Start Date:

February 2010

Completion Date:

January 2012

Related Keywords:

  • Advanced Solid Tumors
  • HSP990
  • HSP90
  • Japan/Korea
  • Phase I
  • advanced solid tumors
  • dose escalation
  • maximum tolerated dose
  • MTD
  • Japanese paatients
  • Korean patients

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