Recent Updates
Recently added Catalysts

AMN107

Phase 2

Leukemia, Myeloid, Chronic | Small molecule | Oncology |Novartis AG|Last Updated: Mar 6, 2017

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

AMN107 · 1 trial · 1 indication

Phase 2 1
NCT00264160Efficacy and Safety of Oral AMN107 in Adults With Chronic Myelogenous Leukemia Resistant and/or Intolerant to Imatinib Mesylate TherapyLeukemia, Myeloid, Chronic
COMPLETED36 Analytics
PHASE2COMPLETED
Efficacy and Safety of Oral AMN107 in Adults With Chronic Myelogenous Leukemia Resistant and/or Intolerant to Imatinib Mesylate Therapy
Leukemia, Myeloid, Chronic
NCT0026416036
Unlock trial analytics

Study Endpoints

Primary Endpoints

Cytogenetic response within 12 months
Every 6 months for 12 months

Secondary Endpoints

To determine the rate of hematologic response at 12 months
Every Visit for 12 months
To determine the rate of molecular response at 12 months
Every 3 months for 12 months
To evaluate the time to cytogenetic and molecular response
At 12 months
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AMN107EXPERIMENTAL -

Interventions

NameTypeDescription
AMN107DRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Imatinib - resistant or - intolerant Philadelphia chromosome-positive CML in blast crisis, accelerated or chronic phase * Males or females ≥ 18 years of age Exclusion Criteria: * Impaired cardiac function * Acute or chronic liver or renal disease * Use of therapeutic coumadi...

Countries:Israel
Unlock Eligibility Criteria

Frequently asked questions about AMN107

What is AMN107 used for?

AMN107 is an investigational small molecule being studied for the treatment of chronic myeloid leukemia and gastrointestinal stromal tumors (GIST). It has been evaluated in clinical trials for patients with chronic myelogenous leukemia resistant or intolerant to imatinib mesylate therapy, and for GIST patients who have failed both imatinib and sunitinib.

Who makes AMN107?

AMN107 is being developed by Novartis AG (ticker: NVS). The company has sponsored clinical trials investigating the drug in oncology indications, including chronic myeloid leukemia and gastrointestinal stromal tumors.

What phase is AMN107 in?

AMN107 has completed Phase 2 clinical trials. The drug is investigational and remains in clinical development, with no approval status indicated. Two Phase 2 studies and one Phase 1 study have been completed, involving a total of 94 participants.

What clinical trials is AMN107 in?

AMN107 has been studied in three completed trials: NCT00135005, a Phase 1 study of AMN107 with imatinib in gastrointestinal stromal tumors (GIST) with 59 participants; NCT00264160, a Phase 2 study in chronic myelogenous leukemia with 36 participants; and NCT00718562, a Phase 2 study in GIST patients who failed imatinib and sunitinib with 35 participants.

How does AMN107 work?

AMN107 is a small molecule developed for oncology. Its specific molecular target has not been disclosed in the available clinical trial information, so its mechanism of action is not detailed here.

Is AMN107 the same as nilotinib?

AMN107 is not identified as nilotinib in the available data. The drug is referred to only as AMN107 in the clinical trial records, with no alternative names provided.