Status:
COMPLETED
Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Ovarian Cancer
Lead Sponsor:
Nektar Therapeutics
Conditions:
Tumor
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 ran...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT00806156
Start Date
October 1 2008
End Date
January 1 2013
Last Update
July 12 2021
Active Locations (20)
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1
Investigator Site - Higland
Highland, California, United States, 92346
2
Investigator Site - Los Angeles
Los Angeles, California, United States, 90033
3
Investigator Site - Newport Beach
Newport Beach, California, United States, 92663
4
Investigator Site - West Palm Beach
West Palm Beach, Florida, United States, 33401