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Sponsored by: |
MolMed S.p.A. |
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Information provided by: | MolMed S.p.A. |
ClinicalTrials.gov Identifier: | NCT00484432 |
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.
Condition | Intervention | Phase |
---|---|---|
Ovarian Cancer |
Drug: NGR-hTNF Drug: doxorubicin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy 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 |
Estimated Enrollment: | 37 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
This is a phase II, open-label, 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Inclusion criteria
Adequate baseline bone marrow, hepatic and renal function, defined as follows:
Patients may have had prior therapy providing the following conditions are met:
Exclusion criteria:
MolMed S.p.A. CLINICAL STUDY PROTOCOL Internal Code: IPR/18.A Confidential page 3 of 51
Contact: Federico Caligaris-Cappio, MD | 39 02 2643 ext 2529 |
Italy | |
Fondazione San Raffaele del Monte Tabor | |
Milan, Italy |
Principal Investigator: | Federico Caligaris-Cappio, MD | Fondazione San Raffaele del Monte Tabor |
Responsible Party: | Molmed ( Molmed ) |
Study ID Numbers: | NGR012 |
Study First Received: | June 7, 2007 |
Last Updated: | July 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00484432 |
Health Authority: | Italy: National Institute of Health |
NGR-hTNF, ovarian cancer, doxorubicin |
Genital Diseases, Female Ovarian cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases |
Urogenital Neoplasms Endocrinopathy Ovarian Diseases Doxorubicin Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses |
Antibiotics, Antineoplastic Pharmacologic Actions Adnexal Diseases |