Recent Updates
Recently added Catalysts

Edotecarin

Phase 3

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

Edotecarin development status

Highest phase Phase 3
Registered trials 3 across 1 sponsor since Aug 2003

Edotecarin target and mechanism

Molecular targetTOP1
Target classInhibitor
ModalitySmall molecule

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedUNCONTROLLED
Total Trials3
Total Enrollment211

FDA Designations

No designations recorded

Edotecarin clinical trials

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
GlioblastomaUnlock trial analytics

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.
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
EdotecarinDRUG -
TemozolomideDRUG -
Carmustine (BCNU)DRUG -
Lomustine (CCNU)DRUG -
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about Edotecarin

What is Edotecarin used for?

Edotecarin was studied in oncology for the treatment of breast neoplasms, glioblastoma, and stomach neoplasms. Clinical trials evaluated it in patients with advanced gastric cancer that progressed or recurred after chemotherapy, in glioblastoma multiforme, and in women with metastatic breast cancer whose disease worsened after anthracycline and taxane therapy.

What does Edotecarin target?

Edotecarin targets topoisomerase I (TOP1). It is a small molecule inhibitor of this enzyme. By inhibiting TOP1, edotecarin interferes with DNA replication and transcription, which is the mechanistic basis for its investigation as an anticancer agent in solid tumors.

Who makes Edotecarin?

Edotecarin is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored the clinical trials evaluating edotecarin in gastric cancer, glioblastoma, and metastatic breast cancer.

What phase is Edotecarin in?

Edotecarin is in Phase 2 development. It is an investigational small molecule and is not approved for any indication. The clinical program includes Phase 2 studies in gastric and breast cancers and a Phase 3 study in glioblastoma, all of which are completed.

What clinical trials is Edotecarin in?

Edotecarin has been evaluated in three completed trials: NCT00087503, a Phase 2 study in advanced gastric cancer; NCT00068952, a Phase 3 study in glioblastoma multiforme; and NCT00067314, a Phase 2 study in metastatic breast cancer. All three trials are completed and no active trials are ongoing.