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

A Phase IA, Dose-escalating Study of LBH589 Administered Intravenously in Adult Patients With Advanced Solid Tumors

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00739414

Enrollment

Registered

2008-08-21

Start date

2008-07-31

Completion date

Unknown

Last updated

2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumor, Cancer

Keywords

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

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.

Interventions

DRUGLBH589

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
To characterize the safety and tolerability of LBH589, including acute and chronic toxicities in Japanese patients with advanced solid tumors.	First cycle

Secondary

Measure	Time frame
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026