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| Sponsor: | Endocyte |
|---|---|
| Information provided by: | Endocyte |
| ClinicalTrials.gov Identifier: | NCT00722592 |
Purpose
The objective of this study is to compare progression-free survival (PFS), based upon investigator assessment using RECIST and clinical findings, in subjects with platinum-resistant ovarian cancer who receive combination therapy with EC145 and pegylated liposomal doxorubicin (PLD/Doxil®/Caelyx®) with that in subjects with platinum-resistant ovarian cancer who receive PLD alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: EC145 Drug: pegylated liposomal doxorubicin (PLD) Drug: EC20 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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: | June 2011 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
EC145 + Pegylated Liposomal Doxorubicin (PLD)
|
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 at centers with EC20 imaging capability 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 at centers with EC20 imaging capability 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)
|
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 at centers with EC20 imaging capability 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.
Patients at centers with EC20 imaging capability will also undergo imaging with the FR-targeting investigational diagnostic agent EC20 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.
Eligibility| 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 adequate organ function including:
Subjects of childbearing potential must:
Exclusion Criteria:
The presence of any of the following will exclude the subject from the study:
Contacts and Locations
Show 77 Study Locations| Study Director: | Richard A Messmann, MD, MHS, MSc | Endocyte |
More Information
| Responsible Party: | Endocyte, Inc. ( Richard Messmann, MD / Vice-President, Medical Affairs ) |
| ClinicalTrials.gov Identifier: | NCT00722592 History of Changes |
| Other Study ID Numbers: | EC-FV-04 |
| Study First Received: | July 23, 2008 |
| Last Updated: | July 2, 2010 |
| Health Authority: | United States: Food and Drug Administration |
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cancer ovarian platinum-resistant |
Phase II EC145 EC20 |
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female |
Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Doxorubicin Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |