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NGR-hTNF in Combination With an Anthracycline in Platinum-resistant Ovarian Cancer (NGR018)

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ClinicalTrials.gov Identifier: NCT03804866
Recruitment Status : Completed
First Posted : January 15, 2019
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
MolMed S.p.A.

Brief Summary:
The primary objective of this extension protocol is to evaluate the early safety of a new schedule of NGR-hTNF given weekly, instead of every 3 or 4 weeks, in a cohort of 12 patients randomized to the experimental arm A, as compared to a reference cohort of 12 patients randomized to an anthracycline alone

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: NGR-hTNF Drug: Pegylated liposomal doxorubicin Drug: Doxorubicin Phase 2

Detailed Description:
In this extension protocol IPR/26 of completed IPR/24 study, considering the relatively short half-life of approximately 1 hour and the favourable toxicity profile of NGR-hTNF, characterized by transient constitutional symptoms occurring during the first day of administration, an additional cohort of 24 patients will be randomized and the 12 patients enrolled in arm A will receive the same dose of NGR-hTNF 0.8 mcg/m2 given as 60 minutes infusion every week. the weekly schedule of NGR-hTNF 0.8 mcg/m2 has previously been tested in several studies

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NGR018: Randomized Phase II Study of NGR-hTNF Plus an Anthracycline Versus an Anthracycline Alone in Platinum-resistant Ovarian Cancer
Actual Study Start Date : March 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016


Arm Intervention/treatment
Experimental: Arm A: NGR-hTNF+ anthracycline
NGR-hTNF+Pegylated Liposomal Doxorubicin or Doxorubicin
Drug: NGR-hTNF
NGR-hTNF: 0.8 mcg/m² as 60 minutes intravenous infusion every week 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/m² iv every 3 weeks for a maximum of 8 cycles

Active Comparator: Arm B: anthracycline
Pegylated Liposomal Doxorubicin or Doxorubicin
Drug: Pegylated liposomal doxorubicin
50 mg/m² iv every 4 weeks until confirmed evidence of disease progression

Drug: Doxorubicin
60 mg/m² iv every 3 weeks for a maximum of 8 cycles




Primary Outcome Measures :
  1. Safety according to NCI-CTCAE criteria (version 4.03) [ Time Frame: from the start of treatment until 28 days after last treatment ]
    To evaluate safety profile related to NGR-hTNF


Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: from randomization date, every 6-8 weeks based on chemotherapy during treatment and every 12 weeks during follow-up until first documented PD or death from any cause, whichever came first, assessed up through study completion, approximately 12 months ]
    Defined as the time from the date of randomization until disease progression, or death

  2. Overall survival (OS) [ Time Frame: from randomization date, every 6-8 weeks based on type of chemotherapy during treatment and every 12 weeks during follow-up until date of death, from any cause, assessed up through study completion, approximately 12 months ]
    defined as the time from the date of randomization until death due to any cause

  3. Response Rate (RR) [ Time Frame: from randomization date, every 6-8 weeks based on chemotherapy during treatment and every 12 weeks during follow-up until first documented PD or death from any cause, whichever came first, assessed up through study completion, approximately 12 months ]
    defined as the percentage of patients who have a best-response rating of complete or partial response, according to standard RECIST criteria

  4. Disease Control Rate (DCR) [ Time Frame: from randomization date, every 6-8 weeks based on chemotherapy during treatment and every 12 weeks during follow-up until first documented PD or death from any cause, whichever came first, assessed up through study completion, approximately 12 months ]
    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

  5. Duration of Disease Control [ Time Frame: from randomization date, every 6-8 weeks based on chemotherapy during treatment and every 12 weeks during follow-up until first documented PD or death from any cause, whichever came first, assessed up through study completion, approximately 12 months ]
    measured from the date of randomization until disease progression, or death due to any cause



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  • ECOG Performance status 0 - 2
  • Life expectancy of 12 weeks or more
  • Normal cardiac function and absence of uncontrolled hypertension
  • Adequate baseline bone marrow, hepatic and renal function defined as follows:

    1. Neutrophils ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; hemoglobin ≥ 9 g/dL
    2. Bilirubin ≤ 1.5 x ULN
    3. AST and/or ALT ≤ 2.5 x ULN in absence of liver metastasis or ≤ 5 x ULN in presence of liver metastasis
    4. 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:

    1. Surgery and radiation therapy: wash-out period of 14 days
    2. 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 or contraindications 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03804866


Locations
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Italy
Ospedale San Raffaele
Milan, Italy, 20132
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Istituto Europeo di Oncologia
Milan, Italy, 20141
Istituto Nazionale Tumori IRCCS Fondazione "Giovanni Pascale"
Naples, Italy, 80131
Sponsors and Collaborators
MolMed S.p.A.
Investigators
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Study Director: Antonio Lambiase, MD MolMed S.p.A.

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Responsible Party: MolMed S.p.A.
ClinicalTrials.gov Identifier: NCT03804866     History of Changes
Other Study ID Numbers: NGR018-IPR/26
2012-005745-20 ( EudraCT Number )
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Keywords provided by MolMed S.p.A.:
NGR-hTNF
Pegylated liposomal doxorubicin
Doxorubicin
Platinum-resistant
Progression or recurrence Ovarian Cancer
Ovarian Cancer
Advanced or metastatic
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action