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Dose-escalating Study of LBH589 in Adult Patients With Advanced Solid Tumors

NCT ID: NCT00739414

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Brief Summary

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This study will characterize the safety, tolerability, biological activity, and pharmacokinetics of LBH589 in Japanese patients with advanced solid tumors whose disease has progressed despite standard therapies, or for whom no standard therapy exists.

Detailed Description

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Conditions

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Cancer Advanced Solid Tumor

Keywords

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Histone Deacetylases HDAC inhibitor LBH589 Advanced solid tumor Adult

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LBH589 (Panobinostat)

Group Type EXPERIMENTAL

LBH589

Intervention Type DRUG

10, 15, 20 mg/m2, i.v. on day 1 and 8 of each 21 day cycle

Interventions

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LBH589

10, 15, 20 mg/m2, i.v. on day 1 and 8 of each 21 day cycle

Intervention Type DRUG

Other Intervention Names

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Panobinostat

Eligibility Criteria

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Inclusion Criteria

1. Patients with histologically or cytologically confirmed, advanced solid tumors whose disease has progressed despite available standard therapies, or for which no standard therapy exists.
2. At least one measurable or non-measurable lesion as defined by modified RECIST Criteria for solid tumors
3. Age ≥20 years old
4. World Health Organization (WHO) Performance Status of ≤2
5. Patients must have the following laboratory values as defined in protocol
6. Life expectancy of ≥ 12 weeks
7. Written informed consent obtained

Exclusion Criteria

1. Patients with evidence of CNS tumor or metastasis
2. Patients with pleural effusion and/or ascites to be drained
3. Patients with any peripheral neuropathy ≥ CTCAE grade 2
4. Impaired cardiac function defined in protocol
5. Acute or chronic liver or renal disease
6. Other concurrent severe and/or uncontrolled medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol
7. Patients who are currently receiving treatment with any of the medications which have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication
8. Patients who have received chemotherapy ≤4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmeceuticals

Locations

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Novartis Investigational Site

Aichi Prefecture, , Japan

Site Status

Novartis Investigational Site

Hokkaido, , Japan

Site Status

Novartis Investigational Site

Hyogo Prefecture, , Japan

Site Status

Countries

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Japan

References

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Morita S, Oizumi S, Minami H, Kitagawa K, Komatsu Y, Fujiwara Y, Inada M, Yuki S, Kiyota N, Mitsuma A, Sawaki M, Tanii H, Kimura J, Ando Y. Phase I dose-escalating study of panobinostat (LBH589) administered intravenously to Japanese patients with advanced solid tumors. Invest New Drugs. 2012 Oct;30(5):1950-7. doi: 10.1007/s10637-011-9751-0. Epub 2011 Oct 1.

Reference Type DERIVED
PMID: 21964801 (View on PubMed)

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=4467

Results for CLBH589A1101 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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CLBH589A1101

Identifier Type: -

Identifier Source: org_study_id