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Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Advanced or Metastatic Ovarian Cancer

NCT00484432 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2018-09-27

No results posted yet for this study

Summary

The main objective of the trial is to document the response rate in patients affected by metastatic ovarian cancer, treated with NGR-hTNF plus doxorubicin. Safety will be established by clinical and laboratory assessment according to NCI-CTC criteria.

Conditions

  • Ovarian Cancer Metastatic Recurrent

Interventions

DRUG

NGR-hTNF

NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every 3 week until confirmed evidence of disease progression or unacceptable toxicity occurs

DRUG

doxorubicin

Doxorubicin: 60mg/m² every 3 weeks, until cumulative dose of 550 mg/m²

Sponsors & Collaborators

  • AGC Biologics S.p.A.

    lead INDUSTRY

Principal Investigators

  • Antonio Lambiase, MD · AGC Biologics S.p.A.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Italy

Study Locations

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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 NCT00484432 on ClinicalTrials.gov