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Etirinotecan pegol

Phase 2

Anaplastic Astrocytomas | Small molecule | Oncology |Nektar Therapeutics|Last Updated: Feb 24, 2016

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01663012Phase II NKTR-102 In Bevacizumab-Resistant High Grade GliomaPHASE2 COMPLETED 20 — — Jul 1, 2012Feb 1, 2015Feb 24, 20161 United States
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Study Endpoints
Primary Endpoints
Progression Free Survival, Assessed by Revised Assessment in Neuro-oncology (RANO) Criteria
6 weeks from first administration of NKTR-102

Will be described using Kaplan-Meier estimates. The PFS probability at 6 weeks (PFS-6week) will be estimated with an 80% power and 95% confidence intervals (80% in accord with the planned alpha level, 95% for comparability with other studies, confidence intervals based on the Greenwood formula for the variance of a survival probability).

Secondary Endpoints
Survival From the Time of First NKTR-102 Dose for Patients With BEV-resistant Glioma Receiving NKTR-102 to Date of Death
From date of first dose of NKTR-102 to date of death, assessed up to 2 years
Overall Survival From Time of Diagnosis
From date of pathologic diagnosis/confirmation of high grade glioma to date of death, assessed up to 2 years.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Drug: Etirinotecan pegolEXPERIMENTAL145 mg/m2 dose
Interventions
NameTypeDescription
Etirinotecan pegolDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Pathologically proven high-grade glioma (WHO III or IV) with astrocytic component and must be in recurrence after treatment with bevacizumab * Patients must have received conventional radiation therapy of total radiation dosage (ranging from 5400 to 6000 cGy administered in da...

Countries:United States
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