Clinical trial NCT00739414: Dose-escalating Study of LBH589 in Adult Patients With Advanced Solid Tumors
Official title: A Phase IA, Dose-escalating Study of LBH589 Administered Intravenously in Adult Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Advanced Solid Tumor
Keywords: Histone Deacetylases
HDAC inhibitor
LBH589
Advanced solid tumor
Adult
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-08-21
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: To characterize the safety and tolerability of LBH589, including acute and chronic toxicities in Japanese patients with advanced solid tumors.
timeFrame: First cycle
Secondary outcomes:
measure: To characterize the pharmacokinetics (PK) of LBH589
timeFrame: First cycle
measure: To evaluate any antitumor activity of LBH589 in patients with advanced solid tumors
timeFrame: Every 2 cycle
Other outcomes:
Locations:
city: Aichi prefecture
country: Japan
facility: Novartis Investigational Site
city: Hokkaido
country: Japan
facility: Novartis Investigational Site
city: Hyogo prefecture
country: Japan
facility: Novartis Investigational Site
Study officials:
affiliation: Novartis Pharmeceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.