Overview

This trial is active, not recruiting.

Condition ovarian cancer
Treatments ngr-htnf, pegylated liposomal doxorubicin, doxorubicin
Phase phase 2
Sponsor MolMed S.p.A.
Start date June 2011
End date June 2016
Trial size 124 participants
Trial identifier NCT01358071, 2010-023613-61, NGR018

Summary

The primary objective of this randomized phase II trial is to compare progression-free survival (PFS) in patients randomized to NGR-hTNF plus an anthracycline versus patients randomized to an anthracycline alone

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
NGR-hTNF+Pegylated Liposomal Doxorubicin or Doxorubicin
ngr-htnf
NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion weekly or every 3 or 4 weeks until confirmed evidence of disease progression or unacceptable toxicity occurs
pegylated liposomal doxorubicin
50 mg/m² iv every 4 weeks until confirmed evidence of disease progression
doxorubicin
60 mg/m^2 iv every 3 weeks for a maximum of 8 cycles
(Active Comparator)
Pegylated Liposomal Doxorubicin or Doxorubicin
pegylated liposomal doxorubicin
50 mg/m² iv every 4 weeks until confirmed evidence of disease progression
doxorubicin
60 mg/m^2 iv every 3 weeks for a maximum of 8 cycles

Primary Outcomes

Measure
Progression-Free Survival (PFS)
time frame: every 6-8-12 weeks

Secondary Outcomes

Measure
Overall survival (OS)
time frame: every 6- 8 -12 weeks
Response Rate (RR)
time frame: every 6 - 8 -12 weeks
Disease Control Rate (DCR)
time frame: every 6 - 8 -12 weeks
Duration of Disease Control
time frame: every 6 - 8 -12 weeks
Safety and Toxicity according to NCI-CTCAE criteria (version 4.03)
time frame: During the study

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Age ≥ 18 years - Histologically-proven ovarian cancer, fallopian tube and primary peritoneal cancer in advanced or metastatic stage - Patients previously treated with a maximum of two platinum-based regimen plus paclitaxel and with documented progressive disease on treatment (refractory patient population) or within 6 months from last chemotherapy cycle (resistant patient population) - Good clinical Conditions - Normal cardiac function - Adequate baseline bone marrow, hepatic and renal function - At least one (not previously irradiated) target lesion or non-measurable disease only, according to RECIST criteria - Patients may have had prior therapy providing the following conditions are met: - Surgery and radiation therapy: wash-out period of 14 days - Systemic anti-tumor therapy: wash-out period of 21 days Exclusion Criteria: - Patients may not receive any other investigational agents while on study - More than two previous chemotherapy lines and previous treatment with anthracycline - Patients with myocardial infarction within the last six months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication - Prolonged QTc interval (congenital or acquired) > 450 ms - History or evidence upon physical examination of CNS disease unless adequately treated - Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol - Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients - Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol - Pregnancy or lactation.

Additional Information

Official title NGR018: Randomized Phase II Study of NGR-hTNF Plus an Anthracycline Versus an Anthracycline Alone in Platinum-resistant Ovarian Cancer
Description Considering the safety/toxicity profile of NGR-hTNF characterized by mild-to-moderate constitutional symptoms, the reversibility of these adverse events generally occurring only during the infusion time; the absence of overlapping toxicities with chemotherapeutic agents; the safety and preliminary antitumor activity observed in previous trial with doxorubicin; and the objective response rate (RR) registered in a phase II trial in previously treated ovarian cancer patients seems justified to evaluate in a randomized phase II trial the efficacy of NGR-hTNF against a doxorubicin-based option in advanced ovarian cancer patients progressing or recurrent after a standard platinum/taxane-based chemotherapy.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by MolMed S.p.A..