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Avastin

Phase 2

Metastatic Breast Cancer | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Apr 14, 2017

Target and mechanism

Molecular targetVEGFA
Target classInhibitor
ModalitySmall molecule

Also known as bevacizumab, Bevacizumab

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

Avastin · 2 trials · 2 indications

Phase 2 2
NCT00618826A Study of Biweekly Gemcitabine, Paclitaxel, and Avastin in Patients With Metastatic Breast CancerMetastatic Breast Cancer
COMPLETED14 Analytics
NCT00192075A Randomized Trial of Avastin + Gemcitabine + 5-Fluorouracil (5FU)/Folinic Acid Versus Avastin + Oxaliplatin + 5FU/Folinic Acid in Metastatic Colorectal CancerColorectal Cancer
COMPLETED84 Analytics
PHASE2COMPLETED
A Study of Biweekly Gemcitabine, Paclitaxel, and Avastin in Patients With Metastatic Breast Cancer
Metastatic Breast CancerUnlock trial analytics
PHASE2COMPLETED
A Randomized Trial of Avastin + Gemcitabine + 5-Fluorouracil (5FU)/Folinic Acid Versus Avastin + Oxaliplatin + 5FU/Folinic Acid in Metastatic Colorectal Cancer
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-free Survival
maximum 50 months

Time from study entry to disease progression or death

Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST)
baseline to measured progressive disease (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)

Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.

Secondary Endpoints

Overall Response Rate
maximum 50 months
Time to Progressive Disease
randomization to the date of first documented disease progression or death due to disease under study, whichever comes first (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)
Progression-Free Survival
randomization to the first date of progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment PeriodEXPERIMENTALTreatment will be administered once every 2 weeks. One cycle of therapy will consist of 14 days. Paclitaxel is administered first after appropriate premedications. Gemcitabine is administered second and Avastin is administered after chemotherapy, all given on day 1 of each cycle.
A+FFGEXPERIMENTALAvastin + Gemcitabine + 5-Fluorouracil (5FU)/Folinic Acid
A+FOLFOX 4ACTIVE_COMPARATORAvastin + Oxaliplatin + 5-Fluorouracil (5FU)/Folinic Acid

Interventions

NameTypeDescription
PaclitaxelDRUGPatients will be premedicated with dexamethasone and diphenhydramine hydrochloride. Patients will received 150mg of paclitaxel via IV over 120 mins.
GemcitabineDRUGPatients will receive 1500mg of Gemcitabine via IV over 30-60 minutes. Gemcitabine will be given after Paclitaxel.
AvastinDRUG10mg/kg will be given via IV over 90 mins (1st dose). Patients must remain under supervision for 1 hr after completion of the initial dose of Avastin. If no side effects occur, shortened, 60-min 2nd infusion, the post-infusion observation period for the subsequent infusions may be shortened to 20 minutes, and eliminated entirely with the fourth and subsequent infusions.
5FU/folinic acidDRUGFolinic Acid: 100 milligrams per square meter (mg/m2) intravenous (IV) over 60 minutes (A+FFG). Folinic Acid: 200 mg/m2 as a 2-hr infusion on Days 1 and 2 of a 14-day cycle (A+FOLFOX 4). 5-Fluorouracil: 450 mg/m2 as an IV bolus in middle of Folinic Acid (A+FFG). 5-Fluorouracil: 400 mg/m2 bolus plus a 600 mg/m2 22-hour infusion on Days 1 and 2 of a 14-day cycle (A+FOLFOX 4).
oxaliplatinDRUG85 mg/m2 as a 2-hour infusion on Day 1 of a 14 day cycle.
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Eligibility Criteria

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

Inclusion Criteria: * Patient must be 18 years of age or older with histologically confirmed breast cancer and clinical evidence of metastatic disease. * Patients must have measurable or non-measurable disease. X-rays, scans or physical examinations used to assess measurable disease must be perform...

Countries:United States
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Competitive Landscape -Breast Cancer 402 trials (matched to "Metastatic Breast Cancer")

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 colorectal cancer and metastatic breast cancer. It has been studied in clinical trials for these oncology indications, including a Phase 2 trial in colorectal cancer and a Phase 2 trial in metastatic breast cancer.

What does Avastin target?

Avastin is a monoclonal antibody, classified as a -mab antibody. It is being developed by Eli Lilly and Company for use in oncology, specifically for colorectal cancer and metastatic breast cancer.

Who makes Avastin?

Avastin is developed by Eli Lilly and Company, a pharmaceutical company traded on the stock exchange under the ticker LLY.

What phase is Avastin in?

Avastin is in Phase 2 clinical development. It has completed two Phase 2 trials, one in colorectal cancer and one in metastatic breast cancer, with a combined enrollment of 98 patients.

What clinical trials is Avastin in?

Avastin has been studied in two completed Phase 2 trials. NCT00192075 evaluated Avastin with gemcitabine and 5FU/folinic acid versus Avastin with oxaliplatin and 5FU/folinic acid in metastatic colorectal cancer. NCT00618826 studied biweekly gemcitabine, paclitaxel, and Avastin in metastatic breast cancer.

Is Avastin the same as bevacizumab?

Yes, Avastin is also known as bevacizumab. Both names refer to the same drug, which is being developed by Eli Lilly and Company for colorectal cancer and metastatic breast cancer.