Combination Therapy of F16IL2 and Paclitaxel in Solid Tumour Patients
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ClinicalTrials.gov Identifier: NCT01134250 |
Recruitment Status
: Unknown
Verified October 2014 by Philogen S.p.A..
Recruitment status was: Recruiting
First Posted
: May 31, 2010
Last Update Posted
: October 21, 2014
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Tracking Information | ||||
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First Submitted Date ICMJE | May 25, 2010 | |||
First Posted Date ICMJE | May 31, 2010 | |||
Last Update Posted Date | October 21, 2014 | |||
Study Start Date ICMJE | June 2008 | |||
Estimated Primary Completion Date | May 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT01134250 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Combination Therapy of F16IL2 and Paclitaxel in Solid Tumour Patients | |||
Official Title ICMJE | Phase Ib/II Study of the Tumour-targeting Human F16IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Paclitaxel in Patients With Advanced Solid Tumours | |||
Brief Summary | This Phase Ib/II study is an open label, multicenter study. The study is divided in two parts: Phase I: an open-label, dose escalation study of F16IL2 in combination with paclitaxel for patients with solid tumours, bladder cancer, breast cancer, metastatic melanoma, mesothelioma, NSCLC, prostate cancer and sarcoma amenable to taxane therapy. Phase II: a prospective, single-arm, multicentre study of a fixed dose of F16IL2 in combination with paclitaxel, equivalent to stage 1 of the Simon two-stage phase II design, for patients with metastatic melanoma, breast cancer and NSCLC amenable to taxane therapy. |
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Detailed Description | Breast cancer is a major cause of cancer mortality, second only to lung cancer as a cause of cancer death in women. The five-year survival rate for localized breast cancer has increased from 80 percent in the 1950s to 98 percent today. However, the mortality rate in the most advanced forms remains unsatisfactory. Indeed, the extensive use of mammography within screening programs has led to cancers being detected earlier, when early treatments may be more effective. A greater understanding of the molecular biology and genetic expression of breast cancer has therefore led to new pre-surgical and post-surgical treatments, including hormone modulators and monoclonal antibodies. Many of these agents have led to decreased mortality and disease recurrence. F16 is a human recombinant antibody fragment in the scFv (single chain Fragment variable) format that is directed against tenascin C, an angiogenesis marker common to most solid tumors independent of the tumor type. ScFv(F16) selectively localizes in tumor tissues in animal models as demonstrated both histologically and during mechanistic studies involving mice transfected with orthotopic human tumours. IL2, the human cytokine interleukin-2, is a potent stimulator of the immune response. It has a central role in the regulation of T cell responses and effects on other immune cells such as natural killer cells, B cells, monocyte/macrophages and neutrophils (Smith, 1988). IL2 can induce tumor regression through its ability to stimulate a potent cell-mediated immune response in vivo (Rosenberg, 2000). |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 Phase 2 |
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Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: F16IL2 in combination with paclitaxel
Intravenous (i.v.) infusions of F16IL2 (Dose escalation: from 5 to 35 MioIU, the dose could be further increased until MTD is reached, following a pharmacokinetic-guided design) on days 1, 8, 15, 29, 36 and 43 over 60 minutes via automated device (perfusor), followed by a 1 hour i.v. infusion of paclitaxel (Dose escalation: from 60 up to 90 mg/m2) on days 1, 8, 15, 29, 36 and 43. Patients with objective tumor responses or stable disease will receive additional combination therapy for a maximum of 6 months, or until disease progression, unacceptable toxicity or withdrawal of consent. |
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Study Arms | Experimental: F16IL2 in combination with paclitaxel
Intervention: Drug: F16IL2 in combination with paclitaxel |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
96 | |||
Original Estimated Enrollment ICMJE |
50 | |||
Estimated Study Completion Date | May 2016 | |||
Estimated Primary Completion Date | May 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: For Phase I, cohorts 1 to 8, of the study:
For Phase I, cohorts 9 onwards:
For Phase II of the study:
For phase I and II of the study:
Exclusion criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Italy | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01134250 | |||
Other Study ID Numbers ICMJE | PH-F16IL2TAXO-05/07 2007-006457-42 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Philogen S.p.A. | |||
Study Sponsor ICMJE | Philogen S.p.A. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Philogen S.p.A. | |||
Verification Date | October 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |