Know Cancer

or
forgot password

A Phase IA/II, Two-arm, Multi-center, Open-label, Dose-escalation Study of LBH589 Administered Orally Via Different Dosing Schedules in Adult Patients With Advanced Hematological Malignancies


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma, Leukemia, Multiple Myeloma

Thank you

Trial Information

A Phase IA/II, Two-arm, Multi-center, Open-label, Dose-escalation Study of LBH589 Administered Orally Via Different Dosing Schedules in Adult Patients With Advanced Hematological Malignancies

Inclusion Criteria


Inclusion criteria:

- Adult patients (≥18 years old) with advanced hematological malignancies who have
relapsed after or are refractory to standard therapy, or for which no standard
therapy exists; or, are considered inappropriate candidates for standard therapy

- World Health Organization (WHO) performance status ≤ 2

- Patients must meet protocol-specified hematologic and non-hematologic laboratory
values

- Patients must have adequate liver and renal function

Exclusion criteria:

- Concurrent brain metastases or leukemic infiltration of the cerebrospinal fluid

- Peripheral neuropathy ≥ CTCAE grade 2

- Unresolved diarrhea ≥ CTCAE grade 2

- Concurrent severe and/or uncontrolled medical conditions which may compromise
participation in the study, including impaired heart function or clinically
significant heart disease, and impaired gastrointestinal function or disease that may
significantly alter aborption of LBH589

- Female patients who are pregnant or breast feeding

- Patients not willing to use an effective method of birth control

- Patients taking medications specified by the protocol as prohibited for
administration in combination with LBH589

- Patients with another primary malignancy that currently requires active intervention
or is currently clinically significant

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Establish the maximum tolerated dose and dose-limiting toxicity for two different dosing schedules (MWF weekly or MWF every other week),

Outcome Time Frame:

2.7 years

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLBH589B2102

NCT ID:

NCT00621244

Start Date:

March 2006

Completion Date:

Related Keywords:

  • Lymphoma
  • Leukemia
  • Multiple Myeloma
  • HDAC inhibitor
  • Oral
  • LBH589
  • Lymphoma
  • Leukemia
  • Multiple myeloma
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Hematologic Neoplasms

Name

Location

Medical College of GeorgiaAugusta, Georgia  30912
Dana Farber Cancer InstituteBoston, Massachusetts  02115