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Etirinotecan pegol

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

Etirinotecan pegol · 1 trial · 3 indications

Phase 2 1
NCT01663012Phase II NKTR-102 In Bevacizumab-Resistant High Grade GliomaAnaplastic Astrocytomas
COMPLETED20 Analytics
PHASE2COMPLETED
Phase II NKTR-102 In Bevacizumab-Resistant High Grade Glioma
Anaplastic Astrocytomas
NCT0166301220
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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 to 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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Frequently asked questions about Etirinotecan pegol

What is Etirinotecan pegol used for?

Etirinotecan pegol is an investigational small molecule being studied for the treatment of anaplastic astrocytomas, a type of brain tumor. It is also being evaluated in other high-grade gliomas, including anaplastic oligodendrogliomas and glioblastomas (GBM). The drug is currently in Phase 2 clinical development.

Who makes Etirinotecan pegol?

Etirinotecan pegol is being developed by Nektar Therapeutics, a biopharmaceutical company traded on the NASDAQ under the ticker symbol NKTR. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with certain brain cancers.

What phase is Etirinotecan pegol in?

Etirinotecan pegol is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to determine its safety and effectiveness for treating anaplastic astrocytomas and other high-grade gliomas.

What clinical trials is Etirinotecan pegol in?

Etirinotecan pegol has been studied in a completed Phase 2 clinical trial with the identifier NCT01663012. This trial, titled 'Phase II NKTR-102 In Bevacizumab-Resistant High Grade Glioma,' enrolled 20 participants in the United States with anaplastic astrocytomas, anaplastic oligodendrogliomas, or glioblastomas (GBM).

Is Etirinotecan pegol the same as NKTR-102?

Yes, Etirinotecan pegol is also known as NKTR-102. In clinical trials, the drug is often referred to by this alternative name. For example, the Phase 2 study NCT01663012 is titled 'Phase II NKTR-102 In Bevacizumab-Resistant High Grade Glioma,' indicating that NKTR-102 is the same compound as Etirinotecan pegol.