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A Study of HSP990 Administered by Mouth in Adult Patients With Advanced Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of HSP990 Administered by Mouth in Adult Patients With Advanced Solid Tumors

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

NCT00879905•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study will study the safety, tolerability and metabolism of a drug called HSP990 when given by mouth once a week or twice weekly to subjects with advanced solid tumors.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients with histologically confirmed, advanced malignant solid tumors whose disease has progressed on standard therapy or for whom no standard therapy exists
•2. All patients must have at least one measurable lesion as defined by RECIST. Irradiated lesions are only evaluable for disease progression
•3. All patients must have documented progressive disease before entering the study
•4. Age ≥ 18 years
•5. World Health Organization (WHO) Performance Status ≤ 2
•6. Life expectancy of ≥ 12 weeks
•7. Patients must have the certain laboratory values
•8. Patients able and willing to swallow capsules
•9. Ability to understand the patient information and informed consent form and comply with the protocol
•10. Signed and dated written informed consent is available
+1 more criteria

Exclusion Criteria

•1. Patients with present or history of CNS metastasis.
•2. Prior treatment with any Hsp90 or HDAC inhibitor compound.
•3. Patients who have not recovered from side effects of previous systemic anticancer therapy to \< CTCAE Grade 2 prior to the first dose
•4. Patients identified to be "poor or intermediate CYP2C9 metabolizers"
•5. Patients who received systemic anti-cancer treatment prior to the first dose of HSP990 within the following time frames:
•* Patients who have received cyclical chemotherapy within a period of time that is shorter than the cycle length used for that treatment (e.g., 6 weeks for nitrosourea, mitomycin-C) prior to starting study drug or who have not recovered from the side effects of such therapy
•* Patients who have received biologic therapy (e.g., antibodies) within a period of time that is ≤ 4 weeks prior to starting study drug or who have not recovered from the side effects of such therapy
•* Patients who have been treated with a continuous or intermittent small molecule therapeutic within a period of time that is ≤ 5 t1/2 or ≤ 4 weeks (whichever is shorter) prior to starting study drug or who have not recovered from the side effects of such therapy
•* Patients who have received any other investigational agents within a period of time that is ≤ 5 t1/2 or less than the cycle length used for that treatment or ≤ 4 weeks (whichever is shorter) prior to starting study drug or who have not recovered from the side effects of such therapy
•* Patients who have received wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy.
+23 more criteria

Locations (3)

Novartis Investigative Site

Toronto, Ontario, Canada

Novartis Investigative Site

Toulouse, France

Novartis Investigative Site

Barcelona, Catalonia, Spain

Key Dates

Start Date

May 1, 2009

Primary Completion Date

July 1, 2012

Completion Date

July 1, 2012

Last Updated

December 8, 2020

Enrollment

ACTUAL participants

Conditions

Advanced Solid Malignancies

Interventions

HSP990

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 8, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of HSP990 Administered by Mouth in Adult Patients With Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

Phase I/Ib Trial of TIraGolumab, AtEzolizumab, and RadScopal Radiation in Patients With Advanced Solid Malignancies (TIGER)

Safety and Efficacy Study of CFI-402411 in Subjects With Advanced Solid Malignancies

Drug-drug Interaction Study With AZD5305 and Itraconazole in Patients With Advanced Solid Malignancies

Effects of LBM and PPIs on Pharmacokinetics and Safety of Regorafenib (BAY 73-4506) in Cancer Patients

Study of AZD9150 and MEDI4736 (Durvalumab) in Japanese Adult Patients With Advanced Solid Malignancies

A Phase I Dose Escalation Study of Erlotinib in Combination With Theophylline