AzTrials
AzTrials

Ovarian Cancer Metastatic RecurrentPhase 2NCT00484432

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

A Phase 2 study testing NGR-hTNF and doxorubicin in people with Ovarian Cancer Metastatic Recurrent, run by AGC Biologics S.p.A. at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer Metastatic Recurrent
What is being tested?
NGR-hTNF and doxorubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
2 sitesItaly
Study dates
Nov 2008to Jun 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 19Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

  • Fondazione San Raffaele del Monte Tabor

    Milan

  • Policlinico Universitario A. Gemelli

    Rome, 00168

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Being tested
NGR-hTNF, doxorubicin
Keywords
NGR-hTNF, Ovarian cancer, Doxorubicin
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NGR-hTNFDrug

    NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every 3 week until confirmed evidence of disease progression or unacceptable toxicity occurs

  • doxorubicinDrug

    Doxorubicin: 60mg/m² every 3 weeks, until cumulative dose of 550 mg/m²

Study groups in NCT00484432
Study groupRoleWhat they receive
A: NGR-hTNF + doxorubicinExperimentalNGR-hTNF plus doxorubicin
Receives: Drug: NGR-hTNF; Drug: doxorubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Antitumor activity defined as response rate

    Evaluated according to Response evaluation criteria in solid tumors (RECIST)

    Measured: during the study

Secondary outcomes (4)

  1. Progression Free Survival (PFS)

    PFS evaluated according to Response evaluation criteria in solid tumors (RECIST)

    Measured: during the study

  2. Overall survival (OS)

    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

    Measured: from the date of randomization to the date of death, assessed up to 6 months

  3. CA125 (U/mL) measurement

    Tumor marker evaluation

    Measured: from the randomization, every 6 weeks until the end of treatment

  4. Safety according to NCI-CTCAE criteria (version 3)

    To evaluate safety profile related to NGR-hTNF

    Measured: during the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2007 (estimated)
  2. Study startNov 2008
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00484432
Sponsor's protocol ID
NGR012
Other IDs
2007-000004-33
Status last verified
Aug 2018
First submitted
7 Jun 2007
Last updated
27 Sep 2018
Results posted
No
Data monitoring committee
No

Publications

  • Lorusso D, Scambia G, Amadio G, di Legge A, Pietragalla A, De Vincenzo R, Masciullo V, Di Stefano M, Mangili G, Citterio G, Mantori M, Lambiase A, Bordignon C. Phase II study of NGR-hTNF in combination with doxorubicin in relapsed ovarian cancer patients. Br J Cancer. 2012 Jun 26;107(1):37-42. doi: 10.1038/bjc.2012.233. Epub 2012 May 29.

    PubMed 22644293

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NGR-hTNF and doxorubicin in people with Ovarian Cancer Metastatic Recurrent, run by AGC Biologics S.p.A. at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Antitumor activity defined as response rate (time frame: during the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00484432, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in