Know Cancer

or
forgot password

A Phase IA/II Multicenter, Dose-escalation Study of Oral AMN107 on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant/Intolerant CML in Chronic or Accelerated Phase or Blast Crisis, Relapsed/Refractory Ph+ ALL, and Other Hematologic Malignancies.


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive), Hypereosinophilic Syndrome, Systemic Mastocytosis

Thank you

Trial Information

A Phase IA/II Multicenter, Dose-escalation Study of Oral AMN107 on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant/Intolerant CML in Chronic or Accelerated Phase or Blast Crisis, Relapsed/Refractory Ph+ ALL, and Other Hematologic Malignancies.


Inclusion Criteria:



Main inclusion criteria include:

- Patients with CML in blast crisis, CML in accelerated phase defined as never in blast
crisis phase, or CML in chronic phase defined as never been in blast crisis phase or
accelerated phase who have: *developed progressive disease during therapy with at
least 600 mg of imatinib per day, -OR- *patients with CML on imatinib therapy, at any
dose, developing progressive disease and the presence of a genetic mutation likely to
result in imatinib resistance -OR- *have developed an intolerance to imatinib

- Relapsed or refractory Ph+ ALL

- Hypereosinophilic syndrome/chronic eosinophilic leukemia.

- Systemic mastocytosis who have a clinical indication for treatment.

- Prior imatinib therapy for patients with Ph+ ALL, HES/CEL and SM is permitted but is
not required

- CML patients who have been treated with an investigational tyrosine kinase inhibitor
who otherwise meet the definition of imatinib-resistance or intolerance are eligible

- Written informed consent prior to any study procedures being performed

Exclusion Criteria:

- Impaired cardiac function

- Patients with severe/chronic or uncontrolled medical conditions (including but not
limited to diabetes, infections, GI impairment, CNS infiltration, liver and kidney
disease)

- Prior and concomitant use of certain medications (including but not limited to
warfarin, chemotherapy, hematopoietic colony-stimulating growth factors, medications
that can affect electrocardiogram test results, other investigational drugs )

- Women who are pregnant or breastfeeding

- Patients with a history of another primary malignancy that is currently clinically
significant or currently requires active intervention.

- Patients unwilling to comply with the protocol.

- Known diagnosis of human immunodeficiency virus (HIV) infection

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

• To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of AMN107 as a single agent when administered as an oral once-daily and twice daily dose to adult patients with imatinib-resistant CML (phase l)

Outcome Time Frame:

study duration

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticlas

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CAMN107A2101

NCT ID:

NCT00109707

Start Date:

May 2004

Completion Date:

September 2012

Related Keywords:

  • Chronic Myelogenous Leukemia
  • Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive)
  • Hypereosinophilic Syndrome
  • Systemic Mastocytosis
  • CML in blast crisis
  • CML in chronic phase
  • CML in accelerated phase
  • Gleevec resistance
  • Gleevec intolerant
  • Gleevec and CML
  • imatinib resistance
  • imatinib intolerant
  • Hypereosinophilic Syndrome
  • Systemic Mastocytosis
  • Chronic eosinophilic syndrome
  • Philadelphia chromosome positive acute lymphoblastic leukemia
  • HES
  • CEL
  • CML
  • SM
  • Ph+ ALL refractory to standard therapy
  • Ph+ALL relapsed
  • AMN107A
  • Blast Crisis
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Mastocytosis
  • Urticaria Pigmentosa
  • Mastocytoma
  • Philadelphia Chromosome
  • Hypereosinophilic Syndrome
  • Mastocytosis, Systemic

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Stanford University Medical CenterStanford, California  94305-5408
Swedish Cancer InstituteSeattle, Washington  98104
University of Rochester Medical CenterRochester, New York  14642
Hackensack University Medical CenterHackensack, New Jersey  07601
Ochsner Clinic FoundationNew Orleans, Louisiana  70121
City of Hope National Medical CenterLos Angeles, California  91010
University of ColoradoDenver, Colorado  80217
Duke University Medical CenterDurham, North Carolina  27710
Oregon Health Sciences UniversityPortland, Oregon  
Wayne State UniversityDetroit, Michigan  48202
Dana Farber Cancer InstituteBoston, Massachusetts  02115
The Jones ClinicGermantown, Tennessee  38138
Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157
H. Lee Moffitt Cancer Center/University of South Florida Dept.of H. Lee MoffittTampa, Florida  33612
University of Chicago Medical Center Dept. of U. of Chicago Hosp(3)Chicago, Illinois  60546
University of Illinois at Chicago Divisionof Hematology/OncologyChicago, Illinois  
Indiana Blood and Marrow Institute Dept of Indiana Blood&Mar (2)Beach Grove, Indiana  46107
Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Div.of Hematologic MalignancieBaltimore, Maryland  21231
University of Michigan Health System Clinical Trials OfficeAnn Arbor, Michigan  48109
Mayo Clinic - RochesterRochester, Minnesota  55905
Roswell Park Cancer Institute Rosewell SCBuffalo, New York  14263
Vanderbilt University Medical Center, Clinical Trials Center Investigational Drug ServicesNashville, Tennessee  37212
MD Anderson Cancer Center/University of TexasHouston, Texas  77030