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Sponsored by: |
MolMed S.p.A. |
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Information provided by: | MolMed S.p.A. |
ClinicalTrials.gov Identifier: | NCT00675012 |
The main objective of the trial is to document the safety of NGR-hTNF administered at low and high doses in combination with a standard oxaliplatin based regimen in patients with metastatic colorectal cancer not amenable to any clinical improvement by current standard treatments
Condition | Intervention | Phase |
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Colon Cancer |
Drug: NGR-hTNF Drug: Oxaliplatin Drug: capecitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety Study |
Official Title: | NGR005: Pilot Study of NGR-hTNF Administered at Low and High Doses in Combination With a Standard Oxaliplatin Based Regimen in Patients With Metastatic Colorectal Cancer |
Estimated Enrollment: | 24 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Phase II, open-label, non-randomized study that will be conducted in two sequential cohorts of patients. Patients with metastatic colorectal cancer not amenable to any clinical improvement by current standard treatments are planned to be enrolled.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Contact: Alberto Sobrero, MD | 0039 010555 |
Italy | |
Azienda Ospedaliera Universitaria San Martino | Recruiting |
Genoa, Italy, 16132 | |
Contact: Alberto Sobrero, MD 39-010-555 |
Principal Investigator: | Alberto Sobrero, MD | Azienda Ospedaliera Universitaria San Martino Genoa, Italy |
Responsible Party: | molmed ( Molmed ) |
Study ID Numbers: | NGR005 |
Study First Received: | May 5, 2008 |
Last Updated: | April 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00675012 History of Changes |
Health Authority: | Italy: National Institute of Health |
NGR-hTNF Capecitabine Oxaliplatin Colon cancer |
Antimetabolites Capecitabine Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Oxaliplatin Digestive System Diseases Gastrointestinal Neoplasms Colonic Neoplasms Colorectal Neoplasms |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
Pharmacologic Actions Intestinal Neoplasms Neoplasms Oxaliplatin Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Colonic Neoplasms Colorectal Neoplasms |