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Completed

NCT Number: NCT03804866

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

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

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Disease Attributes Disease Progression Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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 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

Treatment and study plan

NGR-hTNF

Drug

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

Pegylated liposomal doxorubicin

Drug

50 mg/m² iv every 4 weeks until confirmed evidence of disease progression

Doxorubicin

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AGC Biologics S.p.A.

Industry

Registry information

Official study title

NGR018: Randomized Phase II Study of NGR-hTNF Plus an Anthracycline Versus an Anthracycline Alone in Platinum-resistant Ovarian Cancer

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 15, 2019
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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