Study to Evaluate the Safety and Efficacy of NKTR-102 (PEG-Irinotecan) in Patients With Metastatic or Locally Advanced Ovarian Cancer - Full Text View

Sponsored by:	Nektar Therapeutics
Information provided by:	Nektar Therapeutics
ClinicalTrials.gov Identifier:	NCT00806156

Purpose

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.

Patients will be randomized 1:1 into one of two treatment arms. NKTR-102 will be administered at a dose level of 170mg/m2 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. Approximately 70 patients may be evaluated in this study with approximately 35 patients in each treatment arm.

Condition	Intervention	Phase
Tumor Ovarian Cancer	Drug: NKTR-102 (PEG-Irinotecan)	Phase II

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Irinotecan Irinotecan hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of NKTR-102 (PEG-Irinotecan) When Given on a Q14 Day or a Q21 Day Schedule in Patients With Metastatic or Locally Advanced Platinum-Resistant Ovarian Cancer

Further study details as provided by Nektar Therapeutics:

Primary Outcome Measures:

Objective Response Rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	October 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental NKTR-102	Drug: NKTR-102 (PEG-Irinotecan) NKTR-102 given on a q14 day schedule
2: Experimental NKTR-102	Drug: NKTR-102 (PEG-Irinotecan) NKTR-102 given on a q21 day schedule

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Exclusion Criteria:

Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806156

Locations

United States, Florida
Palm Beach Cancer Center	Recruiting
West Palm Beach, Florida, United States, 33401
Contact: Karen Minder 561-366-4128
Principal Investigator: Daniel L Spitz, MD

Sponsors and Collaborators

Nektar Therapeutics

Investigators

Study Director:

Lorianne Masuoka, MD

Nektar Therapeutics

More Information

Responsible Party:	Nektar Therapeutics ( Lorianne Masuoka, MD, Vice President, Clinical Development )
Study ID Numbers:	08-PIR-04
Study First Received:	December 4, 2008
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00806156
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Genital Diseases, Female
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Irinotecan
Genital Neoplasms, Female

Endocrine System Diseases
Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009