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Study for Women With Platinum Resistant Ovarian Cancer Evaluating EC145 in Combination With Doxil® (PROCEED)

NCT01170650 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 441

Last updated 2021-09-30

No results posted yet for this study

Summary

The purpose of this study is to compare progression-free survival (PFS) (based upon investigator assessment using RECIST v1.1) in participants with platinum-resistant ovarian cancer who receive combination therapy with EC145 and pegylated liposomal doxorubicin (EC145+PLD) with that in participants who receive PLD and placebo.

Conditions

Interventions

DRUG

EC145

IV bolus on days 1,3,5 and 15,17,19 of a 4-week cycle

DRUG

Pegylated Liposomal Doxorubicin (PLD/Doxil®/Caelyx®)

50 mg/m2 (calculated on the basis of ideal body weight) every 4 weeks. Dose reductions permitted for toxicity.

DRUG

placebo

IV bolus on days 1,3,5 and 15,17,19 of a 4-week cycle

DRUG

EC20

During the screening period participants will receive a single intravenous administration of EC20 prior to SPECT imaging

Sponsors & Collaborators

  • Endocyte

    lead INDUSTRY

Principal Investigators

  • Binh Nguyen, MD · Endocyte

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-22
Primary Completion
2015-05-31
Completion
2015-09-08

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01170650 on ClinicalTrials.gov