Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Ovarian Neoplasms

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Carcinoma

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Genital Diseases

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Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

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Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

NGR-hTNF+Pegylated Liposomal Doxorubicin or Doxorubicin

Pegylated Liposomal Doxorubicin or Doxorubicin

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

NGR-hTNF

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

Pegylated liposomal doxorubicin

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

Antonio Lambiase, MD

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

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.

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

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

Defined as the time from the date of randomization until disease progression, or death

defined as the time from the date of randomization until death due to any cause.

defined as the percentage of patients who have a best-response rating of complete or partial response, according to standard RECIST criteria.

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.

measured from the date of randomization until disease progression, or death due to any cause.

To evaluate safety and toxicity profile related to NGR-hTNF

AGC Biologics S.p.A.

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

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

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

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

To evaluate safety profile related to NGR-hTNF

defined as the time from the date of randomization until death due to any cause

defined as the percentage of patients who have a best-response rating of complete or partial response, according to standard RECIST criteria

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

measured from the date of randomization until disease progression, or death due to any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase II Study of NGR-hTNF in Combination With Doxorubicin in Platinum-resistant Ovarian Cancer	NCT01358071	Ovarian Cancer	NGR-hTNF Pegylated lipos... Doxorubicin	18 Years -	AGC Biologics S.p.A.
NGR-hTNF in Combination With an Anthracycline in Platinum-resistant Ovarian Cancer (NGR018)	NCT03804866	Ovarian Cancer	NGR-hTNF Pegylated lipos... Doxorubicin	18 Years -	AGC Biologics S.p.A.

Spots Global Cancer Trial Database for progression or recurrence ovarian cancer