Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Advanced or Metastatic Ovarian Cancer

September 25, 2018 updated by: AGC Biologics S.p.A.

NGR012: A Phase II Study of NGR-hTNF Administered in Combination With Doxorubicin Every 3 Weeks in Patients Affected by Advanced or Metastatic Ovarian Cancer

The main objective of the trial is to document the response rate in patients affected by metastatic ovarian cancer, treated with NGR-hTNF plus doxorubicin. Safety will be established by clinical and laboratory assessment according to NCI-CTC criteria.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a phase II, open-label,single arm, non-randomized study that will be conducted in patients affected by metastatic ovarian cancer, that will be conducted using Simon's two-stage design method.

Study Type

Interventional

Enrollment (Actual)

37

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

  • Italy
      • Milan, Italy
        • Fondazione San Raffaele del Monte Tabor
      • Rome, Italy, 00168
        • Policlinico Universitario A. Gemelli

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:

  • Patients ≥18 years old affected by advanced or metastatic ovarian cancer previously treated with platinum regimens (cis or carboplatin) plus paclitaxel and with documented progression disease within 6 months from last chemotherapy administered (refractory/resistant population) or in progression disease after 6 months from last chemotherapy (platinum regimens plus paclitaxel) administered
  • Rechallenge with platinum regimens
  • No previous exposure to anthracyclines
  • Histologically or cytologically confirmed ovarian carcinoma
  • Life expectancy more than 3 months
  • ECOG Performance status 0 - 1
  • Normal cardiac function (LVEF ≥55%) and absence of uncontrolled hypertension
  • Measurable disease defined as ≥1 unidimensional measurable lesion ≥ 20 mm by conventional technics or ≥ 10 mm ( spiral CT scan or PET); ascites is allowed if present with peritoneal carcinosis

  • Adequate baseline bone marrow, hepatic and renal function, defined as follows:

    • Neutrophils > 1.5 x 10^9/L and platelets > 100 x 10^9/L
    • Bilirubin < 1.5 x ULN
    • AST and/or ALT < 2.5 x ULN in absence of liver metastasis
    • AST and/or ALT < 5 x ULN in presence of liver metastasis
    • Serum creatinine < 1.5 x ULN

  • Patients may have had prior therapy providing the following conditions are met:

    • Chemotherapy and radiotherapy: wash-out period of 28 days
    • Surgery: wash-out period of 14 days
  • Absence of any conditions in which hypervolaemia and its consequences (e.g. increased stroke volume, elevated blood pressure) or haemodilution could represent a risk for the patient (take as reference "Technical data sheet human albumin" specifically used in Pharmacy Department for NGR-hTNF dilution)
  • Patients must give written informed consent to participate in the study

Exclusion criteria:

  • Concurrent anticancer therapy
  • Patients must not receive any other investigational agents while on study
  • New York Heart Association class II-IV cardiac disease
  • Acute angina
  • Patients with myocardial infarction within the last six (6) months
  • Patient with significant peripheral vascular disease
  • Thrombosis of main portal vein
  • Clinical signs of CNS involvement
  • 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. Patients with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A: NGR-hTNF + doxorubicin
NGR-hTNF plus doxorubicin
Drug: NGR-hTNF
NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every 3 week until confirmed evidence of disease progression or unacceptable toxicity occurs
Drug: doxorubicin
Doxorubicin: 60mg/m² every 3 weeks, until cumulative dose of 550 mg/m²

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antitumor activity defined as response rate
Time Frame: during the study
Evaluated according to Response evaluation criteria in solid tumors (RECIST)
during the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: during the study
PFS evaluated according to Response evaluation criteria in solid tumors (RECIST)
during the study
Overall survival (OS)
Time Frame: from the date of randomization to the date of death, assessed up to 6 months
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
from the date of randomization to the date of death, assessed up to 6 months
CA125 (U/mL) measurement
Time Frame: from the randomization, every 6 weeks until the end of treatment
Tumor marker evaluation
from the randomization, every 6 weeks until the end of treatment
Safety according to NCI-CTCAE criteria (version 3)
Time Frame: during the study
To evaluate safety profile related to NGR-hTNF
during the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AGC Biologics S.p.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 1, 2008

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

June 7, 2007

First Submitted That Met QC Criteria

June 7, 2007

First Posted (Estimate)

June 8, 2007

Study Record Updates

Last Update Posted (Actual)

September 27, 2018

Last Update Submitted That Met QC Criteria

September 25, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NGR012
  • 2007-000004-33 (EudraCT Number)

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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