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Edotecarin

Phase 3

Glioblastoma | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Jan 18, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment118

FDA Designations

No designations recorded

Clinical trial landscape

Edotecarin · 3 trials · 4 indications

Phase 3 1Phase 2 2
NCT00068952Study of IV Edotecarin Vs Temozolomide or Carmustine (BCNU) or Lomustine (CCNU) in Patients With Glioblastoma MultiformeGlioblastoma
COMPLETED118 Analytics
PHASE3COMPLETED
Study of IV Edotecarin Vs Temozolomide or Carmustine (BCNU) or Lomustine (CCNU) in Patients With Glioblastoma Multiforme
Glioblastoma
NCT00068952118
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Study Endpoints

Primary Endpoints

To compare the overall survival associated with edotecarin versus that associated with temozolomide or BCNU or CCNU for the treatment of patients with GBM at first relapse previously treated with alkylator-based (neo)adjuvant therapy
To assess the antitumor activity of edotecarin by repeating radiographic assessments at 6-week intervals for all patients.
To assess the anti-tumor activity of single-agent Edotecarin by determining the objective response rate

Secondary Endpoints

To assess measures of tumor control To evaluate measures of clinical benefit To assess the safety profile of edotecarin To assess the PK profile of edotecarin and the potential for drug interactions between anticonvulsants and edotecarin
To determine the time of onset and duration of tumor control, and overall survival.
In addition, the safety and tolerability profile of edotecarin will be assessed, and plasma pharmacokinetic (PK) profile of edotecarin will be evaluated.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
EdotecarinDRUG -
TemozolomideDRUG -
Carmustine (BCNU)DRUG -
Lomustine (CCNU)DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites52

Inclusion Criteria: * Must have biopsy-proven GBM. First relapse (progression or recurrence) of GBM after surgery (or biopsy) and treatment with radiotherapy (conventional fractionated external beam) and chemotherapy (temozolomide- or nitrosurea-based therapy) * Must have past biopsy samples availa...

Countries:United StatesAustraliaAustriaCanadaCroatiaCzechiaFranceGermanyIndiaItalyRussiaSouth AfricaSpainBelgiumTaiwanUnited Kingdom
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Frequently asked questions about Edotecarin

What is Edotecarin used for?

Edotecarin is an investigational small molecule being studied for the treatment of stomach neoplasms, glioblastoma, and breast neoplasms. It has been evaluated in clinical trials for patients with advanced gastric cancer that progressed after chemotherapy, for glioblastoma multiforme, and for metastatic breast cancer that worsened after anthracycline and taxane therapy.

Who is developing Edotecarin?

Edotecarin is being developed by Pfizer, Inc., which trades under the ticker symbol PFE on the New York Stock Exchange. The company has sponsored clinical trials of Edotecarin in oncology indications including breast cancer, glioblastoma, and gastric cancer.

What phase is Edotecarin in?

Edotecarin has been studied in Phase 2 and Phase 3 clinical trials. Completed trials include a Phase 2 study in metastatic breast cancer, a Phase 2 study in advanced gastric cancer, and a Phase 3 study in glioblastoma multiforme. Edotecarin is an investigational drug and is not approved by the FDA.

What clinical trials has Edotecarin been in?

Edotecarin has been studied in three completed clinical trials. NCT00067314 was a Phase 2 study in women with metastatic breast cancer. NCT00068952 was a Phase 3 study comparing Edotecarin to temozolomide or carmustine or lomustine in glioblastoma multiforme. NCT00087503 was a Phase 2 study in advanced gastric cancer.

Is Edotecarin the same as any other drug?

Edotecarin is a distinct investigational small molecule. It has been studied under the name Edotecarin in clinical trials for multiple oncology indications. No alternative names for Edotecarin have been disclosed in the clinical trial records.