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MDV3100

Phase 1

Prostate Cancer | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Nov 21, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment210
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01284920A Study of MDV3100 to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of in Prostate Cancer PatientsPHASE1 COMPLETED 47Nov 2, 2010Jul 2, 2014Nov 21, 20247 Japan
NCT01565928Safety and Tolerability Study of MDV3100 in Combination With Docetaxel in Men With Advanced Prostate CancerPHASE1 COMPLETED 23Jan 24, 2012Feb 26, 2018Apr 22, 20193 United States
NCT00510718A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate CancerPHASE1 COMPLETED 140Jul 23, 2007Apr 2, 2018Oct 3, 20199 United States
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Study Endpoints
Primary Endpoints
Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead EGC
3 months during the study

This measure will be assessed on the dose escalation cohorts.

Tumor response assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
Day 85 and end of long term dosing period

This measure will be assessed on the dose expansion cohort

Percentage of Participants Who Required Study Drug Dose Reduction During Treatment Periods 1 and 2
Treatment Period 1 (Day 1) up to end of Treatment Period 2 (42 days)

Percentage of participants that required dose reductions of Docetaxel and Enzalutamide treatment were reported in this outcome measure. Dose modifications (interruptions or dose reductions) were permitted for participants who had adverse events that were intolerable or could not be improved by other means. Dose reductions or delays were determined according to the prescribing information and at the discretion of the investigator.

Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)
Treatment Period 1 (Day 1) up to end of study treatment (maximum 70 months)

AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Percentage of participants that discontinued study drug due to adverse events were reported in this outcome measure.

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)
Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)

An adverse events (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both SAEs and non-SAEs.

Percentage of Participants With at Least 1 Dose-limiting Toxicity (DLT): Multiple Dose Period
Baseline up to first 35 days of the study treatment in multiple dose period

DLT was defined as a national cancer institute's common toxicity criteria for adverse events (NCI-CTCAE) version 3.0 grade 3 or greater toxicity regardless of perceived causality that is not improved by the use of adequate/maximal medical intervention. Grade 3 alopecia, fever without neutropenia, nausea, vomiting, fatigue, and self-limited or medically controllable adverse events were not considered as DLTs.

Maximum Tolerated Dose (MTD) of MDV3100: Multiple Dose Period
Baseline up to first 35 days of the study treatment in multiple dose period

Tolerability was defined as if less than (\<) 4/12 in participants with no prior exposure to MDV3100 (chemo-naive) and \< 4/12 prior chemotherapy participants experienced a DLT within the first 35 days of the multiple dose period. For doses higher than 360 mg/day, tolerability was defined if \<8/24 participants previously treated with chemotherapy experience a DLT within the first 35 days of the multiple dose period. MTD was defined as a dose below the intolerable dose.

Secondary Endpoints
Prostate Specific Antigen (PSA) Response
Day 85 and end of long term dosing period
Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead ECG
3 months during the study
Number of Participants With Clinically Significant Abnormalities in Vital Signs
T1= Baseline (Day 1) up to a maximum of approximately Month 12; T2 = From Month 10.6 up to a maximum of approximately Month 71.5
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
dose-escalation cohort-1EXPERIMENTALMDV3100 low dose arm
dose-escalation cohort-2EXPERIMENTALMDV3100 middle dose arm
dose-escalation cohort-3EXPERIMENTALMDV3100 high dose arm
dose-expansion cohortEXPERIMENTALdose expansion with MDV3100 middle dose
MDV3100EXPERIMENTAL -
1EXPERIMENTALMDV3100
Interventions
NameTypeDescription
MDV3100DRUGoral
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Eligibility Criteria
Age Range20 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate * Ongoing androgen deprivation therapy with a GnRH analogue or a bilateral orchiectomy * Progressive disease after prior androgen deprivation therapy (medical or surgical castration) * For Expansion Cohor...

Countries:JapanUnited States
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Competitive Landscape -Prostate Cancer 259 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK7PHASE3Pembrolizumab, Enzalutamide, Ifinatamab deruxtecan, Docetaxel, Prednisone
AstraZeneca PLCAZN20PHASE3olaparib, abiraterone, Saruparib, Abiraterone, Darolutamide
Pfizer Inc.PFE12PHASE3Talazoparib with enzalutamide, PF-06821497, Docetaxel, Enzalutamide, Leuprolide Open Label
Johnson & JohnsonJNJ21PHASE3Apalutamide, Androgen Deprivation Therapy, Niraparib, Abiraterone, Prednisone
Eli Lilly and CompanyLLY9PHASE3Abemaciclib, Abiraterone, Prednisone or Prednisolone, -PNT2002, Enzalutamide
Amgen Inc.AMGN7PHASE3Xaluritamig, Abiraterone, Enzalutamide, Cabazitaxel, Docetaxel
Novartis AG Sponsored ADRNVS28PHASE3177Lu-PSMA-617, 68Ga-PSMA-11, ARDT, ADT, AAA617
Exelixis, Inc.EXEL4PHASE3Cabozantinib, Atezolizumab, Abiraterone, Enzalutamide, Prednisone
Candel Therapeutics, Inc.CADL3PHASE3Aglatimagene besadenovec + valacyclovir, aglatimagene besadenovec, valacyclovir, aglatimagene besadenovec + valacyclovir
Bristol-Myers Squibb CompanyBMY2PHASE3BMS-986365, Enzalutamide, Abiraterone, Docetaxel, Predinsone/Prednisolone
BioNTech SE Sponsored ADRBNTX1PHASE3BNT324, Docetaxel, Prednisone/prednisolone
Telix Pharmaceuticals Limited Sponsored ADRTLX3PHASE368Ga-PSMA-11, 177Lu-TLX591, Enzalutamide, Abiraterone, Docetaxel
Sanofi SA Sponsored ADRSNY2PHASE3abiraterone, Docetaxel, Cabazitaxel
Regeneron Pharmaceuticals, Inc.REGN4PHASE2REGN2810, Degarelix, Leuprolide, Docetaxel, BPX-601
Veracyte, Inc.VCYT2PHASE2Darolutamide, Zoladex, Zoladex LA, Decapeptyl sustained release, Depo-Eligard
Kyntra Bio, Inc.KYNB2PHASE2FG-3246, FOR46, Enzalutamide, Pegfilgrastim
Lantheus Holdings IncLNTH3PHASE3Undisclosed
IDEAYA Biosciences, Inc.IDYA3PHASE1IDE-161, Pembrolizumab, IDE034, IDE574, Fulvestrant
Xencor, Inc.XNCR1PHASE2vudalimab
GSK plc Sponsored ADRGSK2PHASE1GSK5471713, GSK5458514
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