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Avastin

Phase 3

Breast Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: Mar 4, 2016

Target and mechanism

Molecular targetVEGFA
Target classInhibitor
ModalitySmall molecule

Also known as Bevacizumab

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

Avastin · 7 trials · 7 indications

Phase 3 2Phase 2 4Phase 1 1
NCT00096967A Study to Evaluate Avastin in Patients Treated in a Previous Genentech-Sponsored Cancer StudyBreast Cancer
COMPLETED100 Analytics
NCT00109070A Study to Evaluate Avastin in Combination With Standard Chemotherapy to Treat Colorectal CancerColorectal Cancer
COMPLETED- Analytics
PHASE3COMPLETED
A Study to Evaluate Avastin in Patients Treated in a Previous Genentech-Sponsored Cancer Study
Breast CancerUnlock trial analytics
PHASE3COMPLETED
A Study to Evaluate Avastin in Combination With Standard Chemotherapy to Treat Colorectal Cancer
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the safety and preliminary efficacy of combining bevacizumab with chemotherapy or Tarceva relative to chemotherapy alone on patients with previously treated advanced non-small cell lung cancer.
Area Under The Plasma Concentration-Time Curve From Zero To Infinity (AUC0-Inf) of 5'-Deoxy-5-fluorouridine 5'-(DFUR)
Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose.

AUC0-infinity represents the area under the concentration-time curve of the analyte (5'-DFUR) in plasma over the time interval from 0 extrapolated to infinity. The analyte 5'-DFUR, the direct precursor of 5-fluorouracil (5-FU), is considered to be the most important metabolite of capecitabine in plasma. The unit of measure was nanograms per millilitre per hour (ng/mL \* hr).

AUC0-inf for Free Platinum
Predose , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the 2 hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3.

AUC0-infinity represents the area under the concentration-time curve of the analyte (free platinum) in plasma over the time interval from 0 extrapolated to infinity. AUC0-inf for free platinum was calculated for each participant from the concentration-data obtained on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3. Free platinum is not bound to plasma proteins and is considered to be the most clinically significant measure of pharmacological and toxicological activity.

Secondary Endpoints

AUC (0-infinity) of Capecitabine and Its Metabolites (5'-DFCR, 5-FU, and FBAL)
Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose
AUC0-last of Capecitabine and Its Metabolites (5'-DFUR, 5'-DFCR, 5 FU, and FBAL)
Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose
Maximum Plasma Concentration (Cmax) of Capecitabine and Its Metabolites (5'-DFUR, 5'-DFCR, 5 FU, and FBAL)
Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose
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Study Design & Arms

MaskingNONE
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -

Interventions

NameTypeDescription
Avastin (bevacizumab)DRUG -
Tarceva (erlotinib HCl)DRUG -
AvastinDRUG7.5mg/kg iv (cycle 3 only)
OxaliplatinDRUG130mg/m2 iv (cycles 1, 2 and 3)
capecitabine [Xeloda]DRUG1000mg/m2 po bid (cycles 1, 2 and 3)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Written informed consent * Previous participation in and completion of one of the following Genentech-sponsored rhuMAb VEGF Phase II or Phase III cancer studies: AVF2107g, AVF2119g, or AVF2192g * Use of an effective means of contraception in men and in women of childbearing po...

Countries:United StatesCanada
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Competitive Landscape -Breast Cancer 402 trials

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
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Frequently asked questions about Avastin

What is Avastin used for?

Avastin is used for treating colorectal cancer, renal cell carcinoma, breast cancer, non-small-cell lung carcinoma, and cancer generally. It is an investigational drug in Phase 3 clinical development for these oncology indications.

What does Avastin target?

Avastin is a monoclonal antibody, classified as a -mab, that targets vascular endothelial growth factor. It is being studied for its role in inhibiting tumor growth in various cancers.

Who makes Avastin?

Avastin is developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's efficacy in multiple cancer types.

What phase is Avastin in?

Avastin is in Phase 3 clinical development. It has completed three trials, including a Phase 3 study, and is not yet approved, meaning it remains investigational.

What clinical trials is Avastin in?

Avastin has been studied in three completed trials: NCT00095225 for non-small-cell lung carcinoma, NCT00096967 for breast and colorectal cancer, and NCT00109226 for metastatic colorectal cancer. These trials are all completed.

Is Avastin the same as Bevacizumab?

Yes, Avastin is also known as Bevacizumab. Both names refer to the same drug, and readers searching for either name will find information about this monoclonal antibody.