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RAD001 and Sorafenib

Phase 1

Renal Cell Carcinoma | Small molecule | Oncology |Novartis AG|Last Updated: Aug 18, 2014

Target and mechanism

Molecular targetmTOR
Target classProtein
ModalitySmall molecule

Also known as RAD001

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

RAD001 and Sorafenib · 1 trial · 1 indication

Phase 1 1
NCT00384969Sorafenib and RAD001 Renal Cell CarcinomaRenal Cell Carcinoma
COMPLETED21 Analytics
PHASE1COMPLETED
Sorafenib and RAD001 Renal Cell Carcinoma
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Study Endpoints

Primary Endpoints

Maximum tolerated dose
weekly

Secondary Endpoints

Objective response rate
8 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALRAD001 and Sorafenib

Interventions

NameTypeDescription
RAD001 and SorafenibDRUGRAD001 2.5mg to 10.0mg PO QD Sorafenib 400mg PO BID
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Eligibility Criteria

Age Range21 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Histologically- or cytologically-confirmed renal cell carcinoma containing predominant (\>50%) clear cell histology, which is metastatic or unresectable 2. Cytoreductive nephrectomy is allowed 3. Evidence of RECIST-defined measurable disease (lesions that can be accurately me...

Countries:United States
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Frequently asked questions about RAD001 and Sorafenib

What is RAD001 used for?

RAD001 is an investigational small molecule being studied in oncology for gastrointestinal stromal tumors, renal cell carcinoma, breast cancer, prostate cancer, carcinoma, and non-small-cell lung carcinoma. It is also being evaluated in other conditions such as tuberous sclerosis complex and prevention of acute rejection in pediatric renal transplant recipients.

What does RAD001 target?

RAD001 targets mTOR, a protein that regulates cell growth and proliferation. By inhibiting mTOR, RAD001 is being studied as a potential treatment for various cancers and other conditions.

Who makes RAD001?

RAD001 is being developed by Novartis AG, which trades under the ticker NVS. The drug is currently in Phase 1 clinical development for oncology indications.

What phase is RAD001 in?

RAD001 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and efficacy.

What clinical trials is RAD001 in?

RAD001 has been studied in several clinical trials, including NCT01122199 (RAD001 plus AMG479 for advanced solid tumors), NCT01275222 (everolimus with imatinib for gastrointestinal stromal tumors), NCT01289912 (RAD001 and neurocognition in tuberous sclerosis complex), and NCT01544491 (everolimus in pediatric renal transplant recipients).

Is RAD001 the same as everolimus?

Yes, RAD001 is also known as everolimus. Clinical trials listed under the name everolimus, such as NCT01275222 and NCT01544491, are studying the same drug compound.