Phase II Study of NGR-hTNF in Combination With Doxorubicin in Platinum-resistant Ovarian Cancer | RxWiki

Phase II Study of NGR-hTNF in Combination With Doxorubicin in Platinum-resistant Ovarian Cancer

Overview[ - collapse ][ - ]

Purpose	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
Condition	Ovarian Cancer
Intervention	Drug: NGR-hTNF Drug: Pegylated liposomal doxorubicin Drug: Doxorubicin
Phase	Phase 2
Sponsor	MolMed S.p.A.
Responsible Party	MolMed S.p.A.
ClinicalTrials.gov Identifier	NCT01358071
First Received	May 19, 2011
Last Updated	January 28, 2013
Last verified	January 2013

Tracking Information[ + expand ][ + ]

First Received Date	May 19, 2011
Last Updated Date	January 28, 2013
Start Date	June 2011
Estimated Primary Completion Date	February 2014
Current Primary Outcome Measures	Progression-Free Survival (PFS) [Time Frame: every 6-8-12 weeks] [Designated as safety issue: No]Defined as the time from the date of randomization until disease progression, or death
Current Secondary Outcome Measures	Overall survival (OS) [Time Frame: every 6- 8 -12 weeks] [Designated as safety issue: No]Defined as the time from the date of randomization until the date of death due to any cause or the last date the patient was known to be alive Response Rate (RR) [Time Frame: every 6 - 8 -12 weeks] [Designated as safety issue: No]Measured both according to RECIST criteria Disease Control Rate (DCR) [Time Frame: every 6 - 8 -12 weeks] [Designated as safety issue: No]Defined as the percentage of patients who have a best-response rating of complete response, partial response, or stable disease, according to standard RECIST criteria Duration of Disease Control [Time Frame: every 6 - 8 -12 weeks] [Designated as safety issue: No]Measured from the date of randomization until disease progression, or death due to any cause Safety and Toxicity according to NCI-CTCAE criteria (version 4.03) [Time Frame: During the study] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	Phase II Study of NGR-hTNF in Combination With Doxorubicin in Platinum-resistant Ovarian Cancer
Official Title	NGR018: Randomized Phase II Study of NGR-hTNF Plus an Anthracycline Versus an Anthracycline Alone in Platinum-resistant Ovarian Cancer
Brief 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
Detailed 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.
Study Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Ovarian Cancer
Intervention	Drug: 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 Drug: Pegylated liposomal doxorubicin 50 mg/m² iv every 4 weeks until confirmed evidence of disease progression Drug: Doxorubicin 60 mg/m^2 iv every 3 weeks for a maximum of 8 cycles
Study Arm (s)	Experimental: Arm A: NGR-hTNF+Pegylated Liposomal Doxorubicin or Doxorubicin Active Comparator: Arm B: Pegylated Liposomal Doxorubicin or Doxorubicin

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	124
Estimated Completion Date	February 2014
Estimated Primary Completion Date	December 2013
Eligibility Criteria	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.
Gender	Female
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Giovanni Scambia, MD
Location Countries	Italy, United Kingdom

Administrative Information[ + expand ][ + ]

NCT Number	NCT01358071
Other Study ID Numbers	NGR018
Has Data Monitoring Committee	No
Information Provided By	MolMed S.p.A.
Study Sponsor	MolMed S.p.A.
Collaborators	Not Provided
Investigators	Study Director: Antonio Lambiase, MD MolMed S.p.A.
Verification Date	January 2013

Locations[ + expand ][ + ]

Ospedale San Raffaele	Milan, Italy, 20132 Contact: Massimo Candiani, MD Principal Investigator: Massimo Candiani, MD Recruiting
Istituto Europeo di Oncologia	Milan, Italy, 20141 Contact: Nicoletta Colombo, MD Principal Investigator: Nicoletta Colombo, MD Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori	Milan, Italy, 20133 Contact: Francesco Raspagliesi, MD Principal Investigator: Francesco Raspagliesi, MD Recruiting
Istituto Nazionale Tumori IRCCS Fondazione "Giovanni Pascale"	Naples, Italy, 80131 Contact: Carmela Pisano, MD Principal Investigator: Carmela Pisano, MD Recruiting
Ospedale S. Maria della Misericordia	Perugia, Italy, 06156 Contact: Anna Maria Mosconi, MD Principal Investigator: Anna Maria Mosconi, MD Recruiting
Policlinico Universitario "Agostino Gemelli"	Rome, Italy, 00168 Contact: Giovanni Scambia, MD Principal Investigator: Giovanni Scambia, MD Recruiting
Beatson Oncology Centre, Gartnavel Hospital	Glasgow, Scotland, United Kingdom, G12 0YN Contact: Nicholas Reed, MD Principal Investigator: Nicholas Reed, MD Recruiting
Clatterbridge Centre for Oncology	Bebington, Wirral, United Kingdom, CH63 4JY Contact: Nasim Ali, MD Principal Investigator: Nasim Ali, MD Recruiting