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RAD001+ AMG479

Phase 1

Neoplasm Metastases | Small molecule | Oncology |Novartis AG|Last Updated: May 10, 2017

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 Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

RAD001+ AMG479 · 1 trial · 1 indication

Phase 1 1
NCT01122199Study of RAD001 + AMG479 for Patients With Advanced Solid TumorsNeoplasm Metastases
COMPLETED27 Analytics
PHASE1COMPLETED
Study of RAD001 + AMG479 for Patients With Advanced Solid Tumors
Neoplasm MetastasesUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the maximum tolerated (MTD) and recommended Phase II doses for AMG479 and RAD001 in patients with refractory solid tumors
1 year
To evaluate the grade and severity of adverse events as a measure of safety and toxicity
2 years

Secondary Endpoints

To determine preliminary antitumor efficacy of AMG479 and RAD001 in solid tumors
5-10 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Open LabelEXPERIMENTALRAD001+ AMG479

Interventions

NameTypeDescription
RAD001 + AMG479DRUGEscalating doses of RAD001 + AMG479. Starting cohort will be 5 mg RAD001 once daily, continuous + AMG479 12 mg/kg on Day 1 and 15 of each 28 day cycle.
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Eligibility Criteria

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

Inclusion Criteria: * Histological or cytological proof of metastatic solid tumor refractory to standard therapies, or for which no standard therapies are available. * Patients in the expansion cohort must have a measurable site of disease according to RECIST (v 1.0) * Laboratory values must be obt...

Countries:United States
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Frequently asked questions about RAD001+ AMG479

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.