Trial record 12 of 61 for:
"Systemic mastocytosis"
A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Blood Related Cancers.
This study is ongoing, but not recruiting participants.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00109707
First received: May 2, 2005
Last updated: September 30, 2012
Last verified: September 2012
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Purpose
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)
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myelogenous Leukemia Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive) Hypereosinophilic Syndrome Systemic Mastocytosis |
Drug: Nilotinib |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
PDGFRA-associated chronic eosinophilic leukemia
PDGFRB-associated chronic eosinophilic leukemia
tetrasomy 18p
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- • 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) [ Time Frame: study duration ] [ Designated as safety issue: Yes ]
- • To characterize the pharmacokinetic profile of AMN107 in serum and, where samples are available, in tumor cells and normal hematopoietic cells. (phase l) [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
- • To evaluate the efficacy and safety of AMN107 in patients with imatinib-resistant or intolerant CML-BC, imatinib-resistant or intolerant CML-AP and imatinib-resistant or intolerant CML-CP. (phase ll) [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
- • To evaluate safety and preliminary anticancer activity of AMN107 in relapsed/refractory patients with Ph+ ALL, HES/CEL and SM. (phase ll) [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To assess changes during and after therapy in malignant cells taken from the bone marrow and/or blood.(phase ll) [ Time Frame: study duration ] [ Designated as safety issue: Yes ]
- To evaluate the population pharmacokinetics of AMN107 (all arms of the study) (phase ll) [ Time Frame: study duration ] [ Designated as safety issue: Yes ]
- To examine whether individual genetic variation in genes relating to drug metabolism, CML and the drug pathway confer differential response to AMN107 (phase ll) [ Time Frame: study duration ] [ Designated as safety issue: Yes ]
- To identify gene expression patterns in tumor cells that are associated with treatment response to AMN107 or that correlate with the severity or progression of CML. (phase ll) [ Time Frame: study duration ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 965 |
| Study Start Date: | May 2004 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Relapsed / refractory Ph+ ALL patients
|
Drug: Nilotinib |
|
Experimental: Arm 2 - Group A and Group B
Imatinib-resistant / intolerant Ph+ CML-BC patients
|
Drug: Nilotinib |
|
Experimental: Arm 3 - Group A and Group
Imatinib-resistant / intolerant Ph+ CML-AP patients
|
Drug: Nilotinib |
|
Experimental: Arm 4 - Group A and Group B
Imatinib-resistant / intolerant Ph+ CML-CP patients
|
Drug: Nilotinib |
|
Experimental: Arm 5
Hypereosinophilic syndrome and chronic eosinophilic leukemia patients
|
Drug: Nilotinib |
|
Experimental: Arm 6
Systemic Mastocytosis patients
|
Drug: Nilotinib |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00109707
Show 97 Study Locations
Show 97 Study LocationsSponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticlas | Novartis Pharmaceuticals |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00109707 History of Changes |
| Other Study ID Numbers: | CAMN107A2101 |
| Study First Received: | May 2, 2005 |
| Last Updated: | September 30, 2012 |
| Health Authority: | United States: Food and Drug Administration European Union: European Medicines Agency Canada: Health Canada |
Keywords provided by Novartis:
|
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 |
Chronic eosinophilic syndrome Philadelphia chromosome positive acute lymphoblastic leukemia HES CEL CML SM Ph+ ALL refractory to standard therapy Ph+ALL relapsed AMN107A |
Additional relevant MeSH terms:
|
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 Neoplasms by Histologic Type Neoplasms Cell Transformation, Neoplastic |
Neoplastic Processes Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Pathologic Processes Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Skin Diseases Mastocytosis, Cutaneous Pigmentation Disorders Translocation, Genetic |
ClinicalTrials.gov processed this record on May 16, 2013