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RAD001, Cetuximab, Irinotecan

Phase 1

Colorectal Cancer | Small molecule | Oncology |Novartis AG|Last Updated: Nov 2, 2012

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

CONTROLLED
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

Clinical trial landscape

RAD001, Cetuximab, Irinotecan · 1 trial · 4 indications

Phase 1 1
NCT00478634A Phase 1 Study Investigating the Combination of RAD001, Cetuximab and Irinotecan as Second-line Therapy After FOLFOX (or XELOX) Plus Bevacizumab in Patients With Metastatic Colorectal CancerColorectal Cancer
COMPLETED19 Analytics
PHASE1COMPLETED
A Phase 1 Study Investigating the Combination of RAD001, Cetuximab and Irinotecan as Second-line Therapy After FOLFOX (or XELOX) Plus Bevacizumab in Patients With Metastatic Colorectal Cancer
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Dose Limiting Toxicities
at end of cycle 2

each cycle was 21 days

Secondary Endpoints

Pharmacokinetics of RAD001, Irinotecan and SN-38
Progressions Free Survival
Overall Survival
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
A1: RAD001 + cetuximab + irinotecanEXPERIMENTALRAD001 30mg weekly oral, 400mg/m2, loading i.v. (250mg/m2 for subsequent weekly dose i.v.), 350mg/m2 every 3 weeks i.v.
B1 dose: RAD001 + cetuximab + irinotecanEXPERIMENTALRAD001 30mg weekly oral, 400mg/m2 loading i.v (250mg/m2 for subsequent weekly dose i.v.), 250mg/m2 every 3 weeks i.v.

Interventions

NameTypeDescription
RAD001, Cetuximab, IrinotecanDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion criteria: * Age ≥ 18 years old and ≤ 65 years old. * Patients with metastatic CRC. Confirmation of CRC diagnosis by histological or cytological specimen from original resection of primary tumor. * Patients who progressed despite prior therapy with FOLFOX (5FU and oxaliplatin) plus bevaciz...

Countries:United States
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Frequently asked questions about RAD001, Cetuximab, Irinotecan

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.