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Sponsored by: |
Endocyte |
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Information provided by: | Endocyte |
ClinicalTrials.gov Identifier: | NCT00722592 |
The objective of this study is to compare progression-free survival (PFS) in subjects with platinum-resistant ovarian cancer who receive combination therapy with EC145 and pegylated liposomal doxorubicin (PLD/Doxil®/Caelyx®)versus PLD alone.
Condition | Intervention | Phase |
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Ovarian Cancer |
Drug: EC145 Drug: pegylated liposomal doxorubicin (PLD) Drug: EC20 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Phase II Trial Comparing EC145 and Pegylated Liposomal Doxorubicin (PLD/Doxil/Caelyx) in Combination, Versus PLD Alone, in Subjects With Platinum-Resistant Ovarian Cancer |
Estimated Enrollment: | 122 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
EC145 + Pegylated Liposomal Doxorubicin (PLD)
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Drug: EC145
2.5 mg IV bolus on days 1,3,5 and 15,17,19 of a 4-week cycle
Drug: pegylated liposomal doxorubicin (PLD)
50 mg/m2 (with dose based on ideal body weight for subjects whose measured body weight is greater than their ideal body weight) intravenous infusion on day 1 of a 4 week cycle. Dose reductions permitted for toxicity.
Drug: EC20
During the screening period, subjects with measurable disease at baseline will receive a single intravenous injection of 0.1 mg EC20 labeled with 20-25 mCi technetium-99m followed by an imaging procedure.
Drug: EC20
During the follow-up period, subjects in Arm A with measurable disease at baseline will have the option of receiving a single intravenous injection of 0.1 mg EC20 labeled with 20-25 mCi technetium-99m followed by an imaging procedure.
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B: Active Comparator
Pegylated Liposomal Doxorubicin (PLD)
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Drug: pegylated liposomal doxorubicin (PLD)
50 mg/m2 (with dose based on ideal body weight for subjects whose measured body weight is greater than their ideal body weight) intravenous infusion on day 1 of a 4 week cycle. Dose reductions permitted for toxicity.
Drug: EC20
During the screening period, subjects with measurable disease at baseline will receive a single intravenous injection of 0.1 mg EC20 labeled with 20-25 mCi technetium-99m followed by an imaging procedure.
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This is a Phase II clinical trial to evaluate the efficacy and safety of the combination of EC145 and pegylated liposomal doxorubicin (PLD; available in the United States as Doxil® and outside the United States as Caelyx®) compared to PLD alone.
EC145 is a drug that is specifically designed to enter cancer cells via the folate vitamin receptor (FR). Experimental evidence shows that this target receptor is expressed on virtually all ovarian cancers. Early clinical evidence in a small number of Phase I subjects and in a subset of subjects in an on-going single-arm Phase II study suggests that EC145 may have antitumor effect in women with advanced ovarian cancer and that it is generally well-tolerated. This evidence suggests that EC145 may be useful as chemotherapy against advanced ovarian cancer.
All patients with measurable disease will also undergo imaging with the FR-targeting investigational diagnostic agent EC20 (FolateScan) during the screening period to assess uptake of this agent into tumors. This non-invasive procedure will provide additional information on the utility of EC20 imaging to identify subjects with the FR molecular "target" before treatment with EC145 therapy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
To qualify for randomization and treatment the following criteria must be met:
Subjects must have either one or both of the following:
Non-cytotoxic (biologic or cytostatic) agents include, but are not limited to, monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction.
Subjects must have adequate organ function including:
Bone Marrow Reserve: Absolute neutrophil count(ANC)≥ 1.5x10^9/L prior to treatment. Subjects on maintenance doses of G-CSF are eligible. Platelets
Subjects of childbearing potential must:
Exclusion Criteria:
The presence of any of the following will exclude the subject from the study:
Study Director: | Richard A Messmann, MD, MHS, MSc | Endocyte |
Responsible Party: | Endocyte, Inc. ( Richard Messmann, MD / Vice-President, Medical Affairs ) |
Study ID Numbers: | EC-FV-04 |
Study First Received: | July 23, 2008 |
Last Updated: | April 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00722592 History of Changes |
Health Authority: | United States: Food and Drug Administration |
cancer ovarian platinum-resistant |
Phase II EC145 EC20 |
Genital Diseases, Female Anti-Bacterial Agents Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Ovarian Cancer |
Endocrine System Diseases Urogenital Neoplasms Endocrinopathy Ovarian Diseases Doxorubicin Endocrine Gland Neoplasms |
Ovarian Neoplasms Antineoplastic Agents Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Antibiotics, Antineoplastic |
Pharmacologic Actions Doxorubicin Adnexal Diseases Genital Diseases, Female Neoplasms Neoplasms by Site Therapeutic Uses Endocrine Gland Neoplasms |