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

NCT00739414 | Completed Phase 1

• 1 other identifier: CLBH589A1101
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Cancer; Advanced Solid Tumor

Keywords

Histone Deacetylases; HDAC inhibitor; LBH589; Advanced solid tumor; Adult

Outcome Measures

Primary Outcomes (1)

• To characterize the safety and tolerability of LBH589, including acute and chronic toxicities in Japanese patients with advanced solid tumors.

  First cycle

Secondary Outcomes (2)

• To characterize the pharmacokinetics (PK) of LBH589

  First cycle

• To evaluate any antitumor activity of LBH589 in patients with advanced solid tumors

  Every 2 cycle

Study Arms (1)

LBH589 (Panobinostat)

EXPERIMENTAL

Drug: LBH589

Interventions

LBH589 DRUG

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

Also known as: Panobinostat

LBH589 (Panobinostat)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with evidence of CNS tumor or metastasis
• Patients with pleural effusion and/or ascites to be drained
• Patients with any peripheral neuropathy ≥ CTCAE grade 2
• Impaired cardiac function defined in protocol
• Acute or chronic liver or renal disease
• Other concurrent severe and/or uncontrolled medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol
• 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
• Patients who have received chemotherapy ≤4 weeks prior to starting study drug or who have not recovered from side effects of such therapy

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (3)

Novartis Investigational Site

Aichi Prefecture, Japan

Location

Novartis Investigational Site

Hokkaido, Japan

Location

Novartis Investigational Site

Hyogo Prefecture, Japan

Location

Related Publications (1)

• 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.

  PMID: 21964801 DERIVED

Related Links

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

MeSH Terms

Conditions

Neoplasms

Interventions

Panobinostat

Intervention Hierarchy (Ancestors)

Hydroxamic Acids; Hydroxylamines; Amines; Organic Chemicals; Hydroxy Acids; Carboxylic Acids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmeceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2008
• First Posted: August 21, 2008
• Study Start: July 1, 2008
• Primary Completion: November 1, 2009
• Last Updated: December 19, 2020

Record last verified: 2010-03

Locations

JP (3)