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

This study is ongoing, but not recruiting participants.

First Received on December 4, 2008. Last Updated on February 17, 2012 History of Changes

Sponsor:	Nektar Therapeutics
Information provided by (Responsible Party):	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.

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/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. After the initial 70 patients have been enrolled, Arm B will enroll approximately 110 additional patients.

Condition	Intervention	Phase
Tumor Ovarian Cancer	Drug: NKTR-102	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

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:	191
Study Start Date:	October 2008
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 NKTR-102	Drug: NKTR-102 NKTR-102 given on a q14 day schedule
Experimental: 2 NKTR-102	Drug: NKTR-102 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
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.

Contacts and Locations

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

Locations

United States, California
Beaver Medical Group
Highland, California, United States, 92346
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Gynecologic Oncology Associates
Newport Beach, California, United States, 92663
United States, Florida
Palm Beach Cancer Center
West Palm Beach, Florida, United States, 33401
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Michigan
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48912
United States, North Carolina
Piedmont Hematology Oncology Associates
Winston-Salem, North Carolina, United States, 27103
United States, Oklahoma
Surgical Gynecological Associates
Oklahoma City, Oklahoma, United States, 73142
United States, Rhode Island
Pharma Resource
East Providence, Rhode Island, United States, 02915
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Belgium
UZ Gent
Gent, Belgium
UZ Leuven
Leuven, Belgium
CHU de Liege
Liege, Belgium
GasthuisZusters Antwerpen
Wilrijk, Belgium
United Kingdom
Mount Vernon Hospital
Middlesex, Northwood, United Kingdom
University Hospital Coventry
Coventry, United Kingdom
Ninewells Hospital
Dundee, United Kingdom, DD1 9SY
Beastson Oncology Centre
Glasgow, United Kingdom, G12 OYN
Freeman Hospital
Newcastle Upon Tyne, United Kingdom, NE7 7DN

Sponsors and Collaborators

Nektar Therapeutics

Investigators

Study Director:

Robert Medve, MD

Nektar Therapeutics

More Information

No publications provided

Responsible Party:	Nektar Therapeutics
ClinicalTrials.gov Identifier:	NCT00806156 History of Changes
Other Study ID Numbers:	08-PIR-04
Study First Received:	December 4, 2008
Last Updated:	February 17, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases

Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on May 23, 2012