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Gleevec, RAD001, and Hydroxyurea

Phase 1

Glioblastoma | Small molecule | Oncology |Novartis AG|Last Updated: Feb 20, 2013

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

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment78

FDA Designations

No designations recorded

Clinical trial landscape

Gleevec, RAD001, and Hydroxyurea · 1 trial · 2 indications

Phase 1 1
NCT00613132Ph I Gleevec in Combo w RAD001 + Hydroxyurea for Pts w Recurrent MGGlioblastoma
COMPLETED78 Analytics
PHASE1COMPLETED
Ph I Gleevec in Combo w RAD001 + Hydroxyurea for Pts w Recurrent MG
GlioblastomaUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine MTD & DLT & Imatinib mesylate & RAD001 when combined w Hydroxyurea among pt w GBM
6 months

Secondary Endpoints

To further evaluate safety & tolerability & Imatinib mesylate in combo w RAD001 & Hydroxyurea
6 months
To evaluate PK on Imatinib mesylate when administered w RAD001 among GBM pt who are on & not on EIAEDs
6 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALPts receiving EIACDs
2EXPERIMENTALPts not receiving EIACDs

Interventions

NameTypeDescription
Gleevec, RAD001, and HydroxyureaDRUGDose of Gleevec will be 400 mg in 1st cohort \& will be increased to 600 mg po/day \& then to 400 mg bid in successive cohorts. Prescribed dose should be administered orally, w large glass of water. Pts should not eat large or high fat meal within 1 hour before or after gleevec dosing. Doses of 600 mg or less should be administered once daily, whereas doses greater than 600 mg should be administered as equal doses twice day. It is recommended that pts take their prescribed Gleevec at same time that they take their prescribed RAD001 \& hydroxyurea, however, 30-60 minute interval between agents is acceptable if required for practical or other compliance issues.
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Eligibility Criteria

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

Inclusion Criteria: * Pts w confirmed GBM, GS, AA, AO \& AOA are presenting in 1st, 2nd/3rd recurrence/relapse * Pts without tumor biopsy \<1 wk/surgical resection \<2 wks prior to starting study drug * For stratum of non-EIAED pts, each pts off all enzyme inducing anticonvulsants for \>2 wks prior...

Countries:United States
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Frequently asked questions about Gleevec, RAD001, and Hydroxyurea

What is Gleevec used for?

Gleevec, also known as imatinib, is being studied for use in lung cancer and prostate cancer. It is an investigational small molecule in Phase 2 clinical development for these oncology indications. Gleevec is not approved for these uses and remains under clinical investigation.

What does Gleevec target?

Gleevec targets ABL1, BCR, KIT, and PDGFRB. It is a kinase inhibitor that acts on these molecular targets. This mechanism is relevant to its investigational use in oncology, including lung cancer and prostate cancer.

Who makes Gleevec?

Gleevec is developed by Novartis AG, which trades under the ticker NVS. The company is conducting clinical trials of Gleevec, also known as imatinib, for oncology indications including lung cancer and prostate cancer.

What phase is Gleevec in?

Gleevec is in Phase 2 clinical development for lung cancer and prostate cancer. It is an investigational drug and has not been approved for these indications. Clinical trials are ongoing or completed to evaluate its safety and efficacy.

What clinical trials is Gleevec in?

Gleevec has one completed Phase 2 trial, NCT00222144, which studied Gleevec and Taxotere in recurrent non-small cell lung cancer with 23 participants. Another completed trial, NCT00251225, studied imatinib and docetaxel in prostate cancer with 49 participants. Both were conducted in the United States.

Is Gleevec the same as imatinib?

Yes, Gleevec is the same as imatinib. The drug is known by both names, with imatinib being the generic name and Gleevec the brand name. Clinical trials may refer to it as either Gleevec or imatinib.