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AMG 386, paclitaxel and carboplatin

Phase 1

Carcinoma | Small molecule | Oncology |Amgen Inc.|Last Updated: Oct 14, 2015

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment27
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01253681Study of AMG 386 in Combination With Paclitaxel and Carboplatin in Subjects With Ovarian CancerPHASE1 COMPLETED 27Nov 1, 2010Jan 1, 2015Oct 14, 20158 Australia, Belgium +1
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Study Endpoints
Primary Endpoints
To evaluate whether AMG 386 in combination with paclitaxel and carboplatin is safe and well tolerated in the first-line treatment of high-risk stage I and stages II-IV epithelial ovarian, primary peritoneal and fallopian tube cancers.
18 weeks of combination therapy
Secondary Endpoints
To evaluate the pharmacokinetics (Cmax, AUC and Cmin) of AMG 386 in combination with carboplatin and paclitaxel
Week 1 until Week 7
To estimate the incidence of anti-AMG 386 antibody formation
Week 1 until maximum of 1 year following first dose
To evaluate the objective response rate (ORR) among subjects receiving AMG 386 in combination with carboplatin and paclitaxel
From date of first dose until the subject reaches End of Study. This will continue until 36 months after the last subject has been enrolled.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AMG 386, paclitaxel and carboplatinEXPERIMENTAL15 mg/Kg AMG 386 IV (intravenous) weekly plus paclitaxel and carboplatin IV Q3W for 18 weeks, followed by 15mg/Kg AMG 386 IV (intravenous) weekly alone for an additional 18 months.
Interventions
NameTypeDescription
AMG 386, paclitaxel and carboplatinDRUG15 mg/Kg AMG 386 IV (intravenous) weekly plus paclitaxel and carboplatin IV Q3W for 18 weeks, followed by 15mg/Kg AMG 386 IV (intravenous) weekly alone for an additional 18 months.
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Female subjects more than 18 years of age with newly diagnosed high-risk FIGO Stage I (grade 3, or aneuploid grade 1 or 2) or Stages II-IV epithelial ovarian, primary peritoneal and fallopian tube cancer with an indication for first-line treatment with paclitaxel and carboplat...

Countries:AustraliaBelgiumSpain
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