Ovarian Cancer Clinical Trial
Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Ovarian Cancer
Summary
This is a multicenter, open-label, two-arm, 2-stage, Phase 2 study of NKTR-102 in patients with metastatic or locally advanced platinum-resistant ovarian cancer.
Approximately 70 patients will be randomized 1:1 into one of two treatment arms. NKTR-102 will be administered at a dose level of 145 mg/m^2 in both arms. In Arm A, NKTR-102 will be given on a q14d schedule. In Arm B, NKTR-102 will be given on a q21d schedule. After the initial 70 patients have been enrolled, Arm B will enroll approximately 110 additional patients.
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer
Inoperable metastatic or locally advanced ovarian cancer
Platinum-resistant ovarian cancer defined as progression by RECIST within 6 months of last dose of most recent platinum drug
Platinum-resistant patients who have progressed after receiving PLD (Doxil/Caelyx)therapy in a platinum-resistant setting or who otherwise unable to receive PLD therapy.
Diseases must be measurable as defined by RECIST in at least 1 lesion not previously irradiated.
ECOG performance score of 0 or 1.
Adequate organ and bone marrow functions at Screening.
Exclusion Criteria:
Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) and have not recovered to NCI-CTCAE grade 1 toxicity prior to Day 1 of Cycle 1
Patients who have had any major surgery within 4 weeks prior to Day 1 of Cycle 1 or minor surgery within 2 weeks prior to Day 1 of Cycle 1
Patients who have received CYP3A4 inducers or inhibitors.
Patients who have received any treatment with a camptothecin derivative (eg. irinotecan, topotecan, SN38 investigational agents, etc.).
Patients with CNS metastases.
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There are 14 Locations for this study
Highland California, 92346, United States
Los Angeles California, 90033, United States
Newport Beach California, 92663, United States
West Palm Beach Florida, 33401, United States
Iowa City Iowa, 52242, United States
Lansing Michigan, 48912, United States
Winston-Salem North Carolina, 27103, United States
Oklahoma City Oklahoma, 73142, United States
East Providence Rhode Island, 02915, United States
Nashville Tennessee, 37203, United States
Charlottesville Virginia, 22908, United States
Gent , , Belgium
Leuven , , Belgium
Liege , , Belgium
Wilrijk , , Belgium
Middlesex Northwood, , United Kingdom
Coventry , , United Kingdom
Dundee , DD1 9, United Kingdom
Glasgow , G12 O, United Kingdom
Newcastle Upon Tyne , NE7 7, United Kingdom
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