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Dose Escalation of HSP990 in Japan/Korea

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ClinicalTrials.gov Identifier: NCT01064089
Recruitment Status : Terminated
First Posted : February 8, 2010
Last Update Posted : December 19, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: HSP990 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Arm Intervention/treatment
Experimental: HSP990
dose escalation
Drug: HSP990



Primary Outcome Measures :
  1. establish maximum tolerated dose (MTD) [ Time Frame: 2.5 years ]

Secondary Outcome Measures :
  1. Safety by measuring occurrence of dose limiting toxicity (DLT) and other adverse events [ Time Frame: 2.5 years ]
  2. Efficacy by collecting data on response (complete response [CR], partial response [PR]) and stable disease (SD) [ Time Frame: 2.5 years ]
  3. 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 ]
  4. Measurement of biomarkers for HSP90 pathway in blood and tissue [ Time Frame: 2.5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01064089     History of Changes
Other Study ID Numbers: CHSP990A1101
First Posted: February 8, 2010    Key Record Dates
Last Update Posted: December 19, 2012
Last Verified: December 2012

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