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Megestrol

Phase 3

Metastatic Breast Cancer | Small molecule | Oncology |Pfizer, Inc.|Last Updated: May 6, 2011

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment84

FDA Designations

No designations recorded

Clinical trial landscape

Megestrol · 1 trial · 1 indication

Phase 3 1
NCT01237327Multicenter Follow Up Study Of Subjects Who Participated In An Original Protocol Of Exemestane Vs. Megestrol Acetate In Postmenopausal Women With Metastatic Breast CancerMetastatic Breast Cancer
COMPLETED84 Analytics
PHASE3COMPLETED
Multicenter Follow Up Study Of Subjects Who Participated In An Original Protocol Of Exemestane Vs. Megestrol Acetate In Postmenopausal Women With Metastatic Breast Cancer
Metastatic Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall Survival
Every 12 weeks up to 6 years

Overall survival in months measured from date of starting treatment in core study to date of death for any reason.

Secondary Endpoints

Objective Response Rate (ORR)
Every 12 weeks up to 6 years
Duration of Response (DR)
Every 12 weeks up to 6 years
Time to Tumor Progression (TTP)
Every 12 weeks up to 6 years
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Study Design & Arms

MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATOR -
2EXPERIMENTAL -

Interventions

NameTypeDescription
Megestrol acetateDRUGMegestrol Acetate 160 mg oral tablets Qd
exemestane (Aromasin)DRUGexemestane (Aromasin) 25 mg oral tablets Qd
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Eligibility Criteria

SexFEMALE
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Previous participation in study 971-ONC-0028-080. Exclusion Criteria: * Subjects who had not previously participated in study 971-ONC-0028-080.

Countries:China
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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 Megestrol

What is Megestrol used for in metastatic breast cancer?

Megestrol is a small molecule being studied for use in metastatic breast cancer. It is an investigational drug in Phase 3 clinical development, evaluated in postmenopausal women with this condition. The drug is being developed by Pfizer, Inc. (NYSE: PFE).

Who makes Megestrol?

Megestrol is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is in Phase 3 clinical development for metastatic breast cancer.

What phase is Megestrol in?

Megestrol is in Phase 3 clinical development. It is an investigational drug, not yet approved, and is being studied for metastatic breast cancer in postmenopausal women. The Phase 3 trial has been completed.

What clinical trials is Megestrol in?

Megestrol has one completed Phase 3 clinical trial, identified as NCT01237327. This multicenter follow-up study enrolled 84 postmenopausal women with metastatic breast cancer in China. The trial was active-controlled and did not use randomization or blinding.

How does Megestrol work?

Megestrol is a small molecule being studied for metastatic breast cancer. Its specific molecular target has not been disclosed in the available information, so its mechanism of action is not detailed here.