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Gleevec

Phase 2

Prostate Cancer | Small molecule | Oncology |Novartis AG|Last Updated: Aug 9, 2017

Target and mechanism

Molecular targetABL1, BCR, KIT, PDGFRB
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL941

Also known as Imatinib

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment49

FDA Designations

No designations recorded

Clinical trial landscape

Gleevec · 1 trial · 1 indication

Phase 2 1
NCT00251225A Study of Imatinib and Docetaxel in Prostate CancerProstate Cancer
COMPLETED49 Analytics
PHASE2COMPLETED
A Study of Imatinib and Docetaxel in Prostate Cancer
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall Time To Progression (TTP)
Up to 24 months

TTP is the amount of time from date of registration to date of first documentation of progression or symptomatic deterioration. For progression, one or more of the following must occur: (1) 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. (2) Increase in PSA by at least 25% from baseline in patients whose PSA did not decrease, and of 50% from nadir in patients whose PSA decreased with a confirmation 3 weeks later. (3) Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). (4) Appearance of any new lesion/site. (5) Death due to disease without prior documentation of progression and without symptomatic deterioration, which is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.

Secondary Endpoints

Prostate-Specific Antigen (PSA) Response Rate
Up to 12 months
Overall Survival (OS)
Up to 60 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Hormone Refractory Prostate CancerEXPERIMENTALGleevec + Docetaxel: Daily Oral Gleevec in Combination with Every-Three-Week Intravenous Docetaxel

Interventions

NameTypeDescription
GleevecDRUGImatinib-400mg po qd for 10 days to commence on day 3. On day 0, Docetaxel 60mg/m\^2 administered IV
DocetaxelDRUG60 mg/m\^2 administered IV on day 0
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Must have a histologic diagnosis of adenocarcinoma of the prostate Stage D2 that is unresponsive or refractory to hormone therapy. Must have metastatic prostate cancer with a rising PSA, and deemed to be hormone refractory. 2. All subjects must have pre-study PSA within 28 da...

Countries:United States
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Competitive Landscape -Prostate Cancer 254 trials

Frequently asked questions about Gleevec

What is Gleevec used for?

Gleevec is being studied for use in prostate cancer and lung cancer. It is an investigational small molecule oncology drug being evaluated in Phase 2 clinical trials for these indications. Gleevec is also known as imatinib.

What does Gleevec target?

Gleevec is a kinase inhibitor, belonging to the -tinib class of drugs. It works by targeting kinases, which are enzymes involved in cell signaling and growth. This mechanism is relevant to its evaluation in cancer treatment.

Who makes Gleevec?

Gleevec is developed by Novartis AG, a company traded on the stock exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate Gleevec for prostate cancer and lung cancer.

What phase is Gleevec in?

Gleevec is in Phase 2 clinical development for prostate cancer and lung cancer. It is an investigational drug, meaning it has not been approved by regulatory authorities for these uses and is still undergoing clinical evaluation.

What clinical trials is Gleevec in?

Gleevec has been studied in two completed Phase 2 trials. NCT00222144 evaluated Gleevec with Taxotere in recurrent non-small cell lung cancer with 23 participants. NCT00251225 studied imatinib with docetaxel in prostate cancer with 49 male participants. Both trials were conducted in the United States.

Is Gleevec the same as imatinib?

Yes, Gleevec is the same as imatinib. Imatinib is the generic name for the drug, while Gleevec is a brand name. Clinical trials may refer to the drug by either name, such as in NCT00251225 which uses imatinib in its title.