A Randomized Double-Blind Phase 3 Trial Comparing Vintafolide (EC145) and Pegylated Liposomal Doxorubicin (PLD/DOXIL®/CAELYX®) In Combination Versus PLD In Participants With Platinum-Resistant Ovarian Cancer
- Conditions
- Platinum Resistant Ovarian CancerTherapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 17.0Level: LLTClassification code 10033130Term: Ovarian cancer NOSSystem Organ Class: 100000004864
- Registration Number
- EUCTR2011-000348-11-CZ
- Lead Sponsor
- Endocyte, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 600
1.Participants must sign an approved informed consent form (ICF).
2.Participants must be = 18 years of age.
3.Participants must have pathology-confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
4.Participants must have at least a single (RECIST v1.1-defined) measurable target lesion evaluable on etarfolatide SPECT scan by the central nuclear medicine reader.
5.Participants must have at least one target lesion positive for folate receptor by etarfolatide scan.
6.Participants must have received prior platinum-based chemotherapy for management of primary disease but must not have received more than 2 prior systemic cytotoxic regimens.
7.Participants must have platinum-resistant ovarian cancer. Note that primary or secondary platinum resistance is allowed.
i. Primary platinum resistance defined as disease that progressed radiologically within 6 months of the last dose of primary platinum therapy.
ii. Secondary platinum resistance defined as disease that progressed radiologically during or within 6 months of completing secondary platinum therapy (i.e. last platinum dose)
8.Participants are allowed to have received, but are not required to have received, one additional non-cytotoxic anti-tumor agent (eg, biologic or cytostatic) for the management of ovarian cancer.
9.For the purpose of obtaining a RECIST v1.1 baseline scan, participants must have a radiological evaluation conducted no more than 28 days prior to beginning study therapy (EC145/Placebo and PLD). Note: For participants with a history of CNS metastasis, baseline radiological imaging must include evaluation of the head.
10.Participants must have had prior debulking surgery (with the exception of participants who have primary peritoneal carcinoma not requiring debulking surgery).
11.Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
12.Participants must have recovered (to baseline/stabilization) from prior therapy-associated acute toxicities.
13.Participants must have adequate organ function:
i.Bone marrow reserve:
a)Absolute neutrophil count (ANC) = 1.5x109/L prior to treatment (1.5x109/L is equivalent to 1.5x103/µL and 1.5xK/µL and 1.5x103/cumm and 1500/µL). Participants on maintenance doses of granulocyte colony stimulating factor (G-CSF) are eligible.
b)Platelets = 100x109/L (100x109/L is equivalent to 100x103/µL and 100xK/µL and 100x103/cumm and 100,000/µL)
c)Hemoglobin = 9 g/dL (9 g/dL is equivalent to 90 g/L and 5.59 mmol/L)
d)Use of supportive care measures (eg, use of white blood cell [WBC] growth factors, antiemetics, epoetin) should follow the ASCO guidelines as listed at www.asco.org. Participants should receive full supportive care, including transfusion of blood as mandated by clinical need; however, transfusions administered for the sole purpose of meeting the study inclusion criteria between the time informed consent is signed and first dose of vintafolide/placebo/PLD is administered are not allowed.
ii.Hepatic: Total bilirubin level = 1.5 x ULN and alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), and alkaline phosphatase levels = 2.5 x ULN.
iii.Renal: Serum creatinine level = 1.5 x ULN or for participants with serum creatinine levels above 1.5 x ULN, creatinine clearance = 50 mL/min/1.73m2 (50 mL/min/1.73m2 is equivalent to 0.83 mL/s/m2).
iv.Cardiac: Left ventricular ejection fraction (LVEF) equal to or greater th
1.Participants’ refractory to primary platinum therapy where refractory” is defined as disease progression within 6 months of first dose of initial platinum-based therapy.
2.Diagnosis of tumor of low-malignant potential”.
3.Prior exposure to PLD or anthracycline therapy.
4.Prior exposure to FR-targeted therapy (eg, vintafolide, EC0225, EC0489, farletuzumab).
5.Folic acid intake such as vitamins, or anti-folate therapy such as methotrexate within one week prior to etarfolatide scan.
6.Prior therapy with vinorelbine (Navelbine®) or vinca-containing compounds.
7.Prior abdominal or pelvic radiation therapy. Prior radiation therapy within the past 3 years to the breast/sternum, dermal lesions, head, or neck.
8.Recent (ie, < 6 weeks) history of abdominal surgery or peritonitis.
9.Serious co-morbidities (as determined by the investigator) such as, but not limited to, active congestive heart failure or recent myocardial infarction. Participants who require antifolate therapy for the management of co-morbid conditions (eg, rheumatoid arthritis) will be excluded from the trial.
10.Participants with bowel obstruction or subocclusion.
11.Pregnant or nursing.
12.Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ).
13.Symptomatic central nervous system (CNS) metastasis.
14.Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational (ie, used for non-approved indications(s) and in the context of a research investigation). Use of low-dose corticosteroid therapy (eg, for nausea prophylaxis) is acceptable; however, concomitant tamoxifen therapy is not. Supportive care measures are allowed.
15.Participants with active infections (e.g. hepatitis or HIV carriers) are excluded from the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method