Overview

A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies

Status:
Completed
Trial end date:
2012-09-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this trial is to assess the efficacy, safety, tolerability, biologic activity, and pharmacokinetics of AMN107 in six groups of patients with one of the following conditions: Relapsed/refractory Ph+ Acute lymphoblastic leukemia (ALL) (arm 1) Group A - Imatinib failure only (arms 2, 3 and 4) - imatinib-resistant or intolerant CML - Chronic Phase (CP) - imatinib-resistant or intolerant CML - Accelerated Phase (AP) - imatinib-resistant or intolerant CML - Blast Crisis (BC) Group B - Imatinib and other TKI failure (arms 2, 3 and 4) - imatinib-resistant or intolerant CML - Chronic Phase (CP) - imatinib-resistant or intolerant CML - Accelerated Phase (AP) - imatinib-resistant or intolerant CML - Blast Crisis (BC) Hypereosinophilic syndrome/chronic eosinophilic leukemia (HES/CEL) (arm 5) Systemic mastocytosis (Sm) (arm 6)
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Imatinib Mesylate
Criteria
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