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

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 II

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

Contacts

Contact: Robert Medve, MD	415-482-5300	RMedve@nektar.com
Contact: Charleen Jue, BS	415-482-5300	cjue@nektar.com

Locations

United States, California
Beaver Medical Group	Recruiting
Highland, California, United States, 92346
Contact: Patricia Ramos 909-862-1191
Principal Investigator: Emad Ibrahim, MD
USC Norris Comprehensive Cancer Center	Recruiting
Los Angeles, California, United States, 90033
Contact: Kristy Watkins 323-865-0452
Principal Investigator: Agustin Garcia, MD
Gynecologic Oncology Associates	Recruiting
Newport Beach, California, United States, 92663
Contact: Katrina Lopez 949-642-5165
Principal Investigator: John P Micha, MD
United States, Florida
Palm Beach Cancer Center	Recruiting
West Palm Beach, Florida, United States, 33401
Contact: Debra Allen-Flaherty 561-366-4111
Principal Investigator: Daniel L Spitz, MD
United States, Iowa
University of Iowa	Recruiting
Iowa City, Iowa, United States, 52242
Contact: Sharon Stockman 319-356-2015
Principal Investigator: David Bender, MD
United States, Michigan
Sparrow Regional Cancer Center	Recruiting
Lansing, Michigan, United States, 48912
Contact: Vicki Gilreath 517-364-2890
Principal Investigator: Joseph Meunier, MD
United States, North Carolina
Piedmont Hematology Oncology Associates	Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Tamika McNair 336-277-8800
Principal Investigator: Charles H Pippitt, MD
United States, Oklahoma
Surgical Gynecological Associates	Recruiting
Oklahoma City, Oklahoma, United States, 73142
Contact: Gary Parker 405-942-3600
Principal Investigator: Jeffrey Smith, MD
United States, Rhode Island
Pharma Resource	Recruiting
East Providence, Rhode Island, United States, 02915
Contact: Kateri Chappell 401-431-0200
Principal Investigator: Vincent A Armenio, MD
United States, Tennessee
Sarah Cannon Research Institute	Recruiting
Nashville, Tennessee, United States, 37203
Contact: Laura Wiehl 615-329-7274
Principal Investigator: Johanna Bendell, MD
United States, Virginia
University of Virginia Health System	Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Heather Lothasmer 314-454-9924
Principal Investigator: Linda Duska, MD
Belgium
UZ Gent	Recruiting
Gent, Belgium
Contact: Ann Clue 32 9 332 26 91
Principal Investigator: Hannelore Denys, MD
UZ Leuven	Recruiting
Leuven, Belgium
Contact: Veerle Sevases 32 16 34 46 35
Contact: Joke DeRoover 32 16 34 46 35
Principal Investigator: Ignace Vergote, MD
CHU de Liege	Recruiting
Liege, Belgium
Contact: Maude Pron 32 4 366 72 01
Principal Investigator: Christine Genningens, MD
GasthuisZusters Antwerpen	Recruiting
Wilrijk, Belgium
Contact: Ann Vermylen 32 3 443 37 59
Principal Investigator: Luc Y. Dirix, MD
United Kingdom
Mount Vernon Hospital	Recruiting
Middlesex, Northwood, United Kingdom
Contact: Gavin Shreeves 44 1923 844 190
Principal Investigator: Gordon J Rustin, MD
University Hospital Coventry	Recruiting
Coventry, United Kingdom
Contact: Helen Wilcox 44 (0) 2476 967 497
Principal Investigator: Christopher Pool, MD
Ninewells Hospital	Recruiting
Dundee, United Kingdom, DD1 9SY
Contact: Hebbie Forbes 44 1382 660 111
Principal Investigator: Michelle Ferguson, MD
Beastson Oncology Centre	Recruiting
Glasgow, United Kingdom, G12 OYN
Contact: Laura Douglas 44 1413 017 057
Principal Investigator: Nick Reed, MD
Freeman Hospital	Recruiting
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Contact: Angela Robinson 44 0191 213 8684
Principal Investigator: Graham Dark, MD

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 1, 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 February 09, 2012