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

Novartis

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumor; Cancer

Treatments: Drug: LBH589

Study type: Interventional

Funder types: Industry

Identifiers

NCT00739414

CLBH589A1101

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

LBH589 (Panobinostat)

Experimental group

Treatment:

Drug: LBH589