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AMN107- NILOTINIB

Phase 2

Gastrointestinal Stromal Tumors (GIST) | Small molecule | Oncology |Novartis AG|Last Updated: Jun 22, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

Clinical trial landscape

AMN107- NILOTINIB · 1 trial · 1 indication

Phase 2 1
NCT00633295Phase II Study Aiming to Evaluate the Efficacy and Safety of Nilotinib Patients With Gastrointestinal Stromal Tumors (GIST) Resistant or Intolerant to Imatinib and or to 2nd Line Tyrosine Kinas (TK) InhibitorGastrointestinal Stromal Tumors (GIST)
COMPLETED9 Analytics
PHASE2COMPLETED
Phase II Study Aiming to Evaluate the Efficacy and Safety of Nilotinib Patients With Gastrointestinal Stromal Tumors (GIST) Resistant or Intolerant to Imatinib and or to 2nd Line Tyrosine Kinas (TK) Inhibitor
Gastrointestinal Stromal Tumors (GIST)Unlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the efficacy of nilotinib in GIST patients resistant or intolerant to imatinib and or 2nd line TK inhibitor as measured by tumor up take of FDG PET quantitated by maximum
6 months

Secondary Endpoints

To assess the safety and tolerability of nilotinib as measured by rate and severity of adverse events
6 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
nilotinibEXPERIMENTAL -

Interventions

NameTypeDescription
AMN107- NILOTINIBDRUGThe dose of nilotinib will be 400 mg bid.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion criteria: * Age ≥ 18 years at Visit 1 * Radiological confirmation of disease progression (CT scan PET-CT, or MRI) during imatinib therapy, on 600- 800 mg per day for at least 6 weeks. * Radiological confirmation of disease progression (CT scan or MRI and PET-CT) during 2nd line TK inhibit...

Countries:Israel
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Frequently asked questions about AMN107- NILOTINIB

What is AMN107 (nilotinib) used for?

AMN107, also known as nilotinib, is an investigational small molecule being studied for the treatment of gastrointestinal stromal tumors (GIST). It is specifically being evaluated in patients whose tumors are resistant or intolerant to imatinib and/or a second-line tyrosine kinase inhibitor. The drug is in Phase 2 clinical development.

What does AMN107 (nilotinib) target?

AMN107, or nilotinib, is a tyrosine kinase inhibitor. It is being studied in gastrointestinal stromal tumors (GIST) that are resistant or intolerant to imatinib and/or a second-line tyrosine kinase inhibitor. The drug works by inhibiting tyrosine kinase enzymes involved in tumor growth.

Who makes AMN107 (nilotinib)?

AMN107, also known as nilotinib, is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 2 clinical development for gastrointestinal stromal tumors (GIST).

What phase is AMN107 (nilotinib) in?

AMN107, also known as nilotinib, is in Phase 2 clinical development. It is an investigational drug being studied for the treatment of gastrointestinal stromal tumors (GIST) that are resistant or intolerant to imatinib and/or a second-line tyrosine kinase inhibitor. It has not been approved by regulatory authorities.

What clinical trials is AMN107 (nilotinib) in?

AMN107, also known as nilotinib, has one completed Phase 2 clinical trial registered under NCT00633295. This trial evaluated the efficacy and safety of nilotinib in patients with gastrointestinal stromal tumors (GIST) resistant or intolerant to imatinib and/or a second-line tyrosine kinase inhibitor. The study enrolled 9 participants in Israel.

Is AMN107 the same as nilotinib?

Yes, AMN107 is the same as nilotinib. The drug is being developed by Novartis AG for the treatment of gastrointestinal stromal tumors (GIST) that are resistant or intolerant to imatinib and/or a second-line tyrosine kinase inhibitor. It is currently in Phase 2 clinical development.