Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Ovarian Cancer

Completed · Phase 2

Conditions studied: Tumor, Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT00806156

Run by

Nektar Therapeutics

People needed

178

Starts

2008-10-01

Expected to finish

2013-01-01

Last updated by the study team

2021-07-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigator Site - Higland — Highland, California, United States
• Investigator Site - Los Angeles — Los Angeles, California, United States
• Investigator Site - Newport Beach — Newport Beach, California, United States
• Investigator Site - West Palm Beach — West Palm Beach, Florida, United States
• Investigator Site - Iowa City — Iowa City, Iowa, United States
• Investigator Site - Lansing — Lansing, Michigan, United States
• Investigator Site - Winston-Salem — Winston-Salem, North Carolina, United States
• Investigator Site - Oklahoma City — Oklahoma City, Oklahoma, United States
• Investigator Site - East Providence — East Providence, Rhode Island, United States
• Investigator Site - Nashville — Nashville, Tennessee, United States
• Investigator Site - Charlottesville — Charlottesville, Virginia, United States
• Investigator Site - Gent — Ghent, Belgium
• Investigator Site - Leuven — Leuven, Belgium
• Investigator Site - Liege — Liège, Belgium
• Investigator Site - Wilrijk — Wilrijk, Belgium
• Investigator Site - Middlesex — Middlesex, Northwood, United Kingdom
• Investigator Site - Coventry — Coventry, United Kingdom
• Investigator Site - Dundee — Dundee, United Kingdom
• Investigator Site - Glasgow — Glasgow, United Kingdom
• Investigator Site - Newcastle Upon Tyne — Newcastle upon Tyne, United Kingdom

Full record on ClinicalTrials.gov

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