- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01358071
Phase II Study of NGR-hTNF in Combination With Doxorubicin in Platinum-resistant Ovarian Cancer (NGR018)
September 25, 2018 updated by: AGC Biologics S.p.A.
NGR018: Randomized Phase II Study of NGR-hTNF Plus an Anthracycline Versus an Anthracycline Alone in Platinum-resistant Ovarian Cancer
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
119
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Milan, Italy, 20132
- Ospedale San Raffaele
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Milan, Italy, 20133
- Fondazione IRCCS Istituto Nazionale dei Tumori
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Milan, Italy, 20141
- Istituto Europeo di Oncologia
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Naples, Italy, 80131
- Istituto Nazionale Tumori IRCCS Fondazione "Giovanni Pascale"
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Perugia, Italy, 06156
- Ospedale S. Maria Della Misericordia
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Rome, Italy, 00168
- Policlinico Universitario "Agostino Gemelli"
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Scotland
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Glasgow, Scotland, United Kingdom, G12 0YN
- Beatson Oncology Centre, Gartnavel Hospital
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Wirral
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Bebington, Wirral, United Kingdom, CH63 4JY
- Clatterbridge Centre for Oncology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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)
- ECOG Performance status 0 - 2
- Life expectancy of 12 weeks or more
- Normal cardiac function
Adequate baseline bone marrow, hepatic and renal function defined as follows:
- Neutrophils ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; hemoglobin ≥ 9 g/dL
- Bilirubin ≤ 1.5 x ULN
- AST and/or ALT ≤ 2.5 x ULN in absence of liver metastasis or ≤ 5 x ULN in presence of liver metastasis
- Serum creatinine < 1.5 x ULN
- 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
- Patients must give written informed consent to participate in the study
Exclusion Criteria:
- Patients must 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A: NGR-hTNF+ anthracycline
NGR-hTNF+Pegylated Liposomal Doxorubicin or Doxorubicin
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NGR-hTNF: 0.8 mcg/m² as 60 minutes intravenous infusion weekly or every 3 or 4 weeks until confirmed evidence of disease progression or unacceptable toxicity occurs
50 mg/m² iv every 4 weeks until confirmed evidence of disease progression
60 mg/m² iv every 3 weeks for a maximum of 8 cycles
|
Active Comparator: Arm B: anthracycline
Pegylated Liposomal Doxorubicin or Doxorubicin
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50 mg/m² iv every 4 weeks until confirmed evidence of disease progression
60 mg/m² iv every 3 weeks for a maximum of 8 cycles
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-Free Survival (PFS)
Time Frame: from the date of randomization, every 6 and 8 weeks based on type of chemotherapy during treatment and every 12 weeks during the follow-up until PD or death
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Defined as the time from the date of randomization until disease progression, or death
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from the date of randomization, every 6 and 8 weeks based on type of chemotherapy during treatment and every 12 weeks during the follow-up until PD or death
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: from the date of randomization, every 6 and 8 weeks based on type of chemotherapy during treatment and every 12 weeks during follow-up until death
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defined as the time from the date of randomization until death due to any cause.
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from the date of randomization, every 6 and 8 weeks based on type of chemotherapy during treatment and every 12 weeks during follow-up until death
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Response Rate (RR)
Time Frame: from the date of randomization, every 6 and 8 weeks based on type of chemotherapy during treatment and every 12 weeks during the follow-up until PD or death
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defined as the percentage of patients who have a best-response rating of complete or partial response, according to standard RECIST criteria.
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from the date of randomization, every 6 and 8 weeks based on type of chemotherapy during treatment and every 12 weeks during the follow-up until PD or death
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Disease Control Rate (DCR)
Time Frame: from the date of randomization, every 6 and 8 weeks based on type of chemotherapy during treatment and every 12 weeks during the follow-up until PD or death
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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.
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from the date of randomization, every 6 and 8 weeks based on type of chemotherapy during treatment and every 12 weeks during the follow-up until PD or death
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Duration of Disease Control
Time Frame: from the date of randomization, every 6 and 8 weeks based on type of chemotherapy during treatment and every 12 weeks during the follow-up until PD or death
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measured from the date of randomization until disease progression, or death due to any cause.
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from the date of randomization, every 6 and 8 weeks based on type of chemotherapy during treatment and every 12 weeks during the follow-up until PD or death
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Safety and Toxicity according to NCI-CTCAE criteria (version 4.03)
Time Frame: from the start of treatment until 28 days after last treatment
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To evaluate safety and toxicity profile related to NGR-hTNF
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from the start of treatment until 28 days after last treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2011
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
May 19, 2011
First Submitted That Met QC Criteria
May 20, 2011
First Posted (Estimate)
May 23, 2011
Study Record Updates
Last Update Posted (Actual)
September 27, 2018
Last Update Submitted That Met QC Criteria
September 25, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Doxorubicin
- Liposomal doxorubicin
Other Study ID Numbers
- NGR018
- 2010-023613-61 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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