Know Cancer

or
forgot password

A Phase II Study of Oral Single Agent Panobinostat in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)


Phase 2
18 Years
85 Years
Not Enrolling
Both
Refractory Leukemia, Acute Myelogenous Leukemia

Thank you

Trial Information

A Phase II Study of Oral Single Agent Panobinostat in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)


Inclusion Criteria:



- Written informed consent prior to study-specific screening procedures

- Life expectancy of ≥ 60 days

- Eastern Cooperative Group (ECOG) performance status ≤ 2

- Refractory AML with confirmed initial diagnosis of de novo AML (excluding APL) - OR-
Refractory AML with confirmed initial diagnosis of AML (excluding APL) secondary to
AHD or MDS with either condition precedent to AML (MDS/AHD)

- Negative serum pregnancy test (within 7 days of first dose)

- Negative urine pregnancy test immediately prior to first dose

Exclusion Criteria:

- Known HIV

- Psychiatric disorder that interferes with ability to understand the study and give
informed consent, and/or would impact study participation or follow-up

- Concurrent use of medications that might prolong the QT interval or of inducing
Torsade de Pointes

- Female patients who are pregnant or breast-feeding or patients of childbearing
potential who are not willing to use a double barrier method of contraception during
the study and for 3 months following the last dose of study drug.

- Male patients whose sexual partner(s) are women of childbearing potential who are not
willing to use a double method of contraception, one of which includes a condom,
during the study and for 3 months after the end of treatment

- Patient is unable to swallow capsules

- Patients with impaired gastrointestinal systems which might cause interference with
digesting and absorbing panobinostat

Other Protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

CRR [complete remission rate (CR/CRi)]

Outcome Time Frame:

June 2011

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLBH589B2213

NCT ID:

NCT00880269

Start Date:

August 2009

Completion Date:

February 2012

Related Keywords:

  • Refractory Leukemia
  • Acute Myelogenous Leukemia
  • Acute myeloid leukemia
  • AML
  • relapsed acute myeloid leukemia
  • refractory AML
  • refractory de novo AML
  • refractory secondary AML
  • secondary AML
  • AML following myelodysplastic syndrome (MDS)
  • AML following antecedent hematological disorder (AHD)
  • AML resistant to therapy
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

University of Chicago Medical Center Dept. of U. of Chicago Hosp(3)Chicago, Illinois  60546
Memorial Sloan Kettering Cancer Center Dept. of MSKCC (2)New York, New York  10021
Methodist Cancer Center Nebraska Methodist Hospital(2)Omaha, Nebraska  68114
North Shore University Hospital North Shore UnivManhasset, New York  10030
Oregon Health Sciences University Dept. of OHSU (2)Portland, Oregon  97239
University of Texas Southwestern Medical Center Dept of Simmons Cancer CenterDallas, Texas  75390-8527
MD Anderson Cancer Center/University of Texas Dept of MD Anderson (14)Houston, Texas  77030-4009