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.

View Eligibility Criteria

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.

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

178

Study ID:

NCT00806156

Recruitment Status:

Completed

Sponsor:

Nektar Therapeutics

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There are 14 Locations for this study

See Locations Near You

Investigator Site - Higland
Highland California, 92346, United States
Investigator Site - Los Angeles
Los Angeles California, 90033, United States
Investigator Site - Newport Beach
Newport Beach California, 92663, United States
Investigator Site - West Palm Beach
West Palm Beach Florida, 33401, United States
Investigator Site - Iowa City
Iowa City Iowa, 52242, United States
Investigator Site - Lansing
Lansing Michigan, 48912, United States
Investigator Site - Winston-Salem
Winston-Salem North Carolina, 27103, United States
Investigator Site - Oklahoma City
Oklahoma City Oklahoma, 73142, United States
Investigator Site - East Providence
East Providence Rhode Island, 02915, United States
Investigator Site - Nashville
Nashville Tennessee, 37203, United States
Investigator Site - Charlottesville
Charlottesville Virginia, 22908, United States
Investigator Site - Gent
Gent , , Belgium
Investigator Site - Leuven
Leuven , , Belgium
Investigator Site - Liege
Liege , , Belgium
Investigator Site - Wilrijk
Wilrijk , , Belgium
Investigator Site - Middlesex
Middlesex Northwood, , United Kingdom
Investigator Site - Coventry
Coventry , , United Kingdom
Investigator Site - Dundee
Dundee , DD1 9, United Kingdom
Investigator Site - Glasgow
Glasgow , G12 O, United Kingdom
Investigator Site - Newcastle Upon Tyne
Newcastle Upon Tyne , NE7 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

178

Study ID:

NCT00806156

Recruitment Status:

Completed

Sponsor:


Nektar Therapeutics

How clear is this clinincal trial information?

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