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Dose Escalation of HSP990 in Japan/Korea

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01064089
First received: February 1, 2010
Last updated: December 17, 2012
Last verified: December 2012
History of Changes
  Purpose

This study is 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.


Condition Intervention Phase
Advanced Solid Tumors
 Drug: HSP990
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • establish maximum tolerated dose (MTD) [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety by measuring occurrence of dose limiting toxicity (DLT) and other adverse events [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
  • Efficacy by collecting data on response (complete response [CR], partial response [PR]) and stable disease (SD) [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • Establishment of a pharmacokinetic profile by collecting information on parameters including but not limited to Cmax, Tmax, T1/2 and AUC in plasma samples [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • Measurement of biomarkers for HSP90 pathway in blood and tissue [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: February 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HSP990
dose escalation
 Drug: HSP990

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01064089

Locations
Japan
Novartis Investigative Site
Nagoya, Aichi, Japan, 466-8560
Novartis Investigative Site
Kashiwa, Chiba, Japan, 277-8577
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01064089     History of Changes
Other Study ID Numbers: CHSP990A1101
Study First Received: February 1, 2010
Last Updated: December 17, 2012
Health Authority: United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:
HSP990
HSP90
Japan/Korea
Phase I
advanced solid tumors
 dose escalation
maximum tolerated dose
MTD
Japanese paatients
Korean patients

ClinicalTrials.gov processed this record on May 23, 2013