Trial record 1 of 1 for:
08-PIR-04
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.
Sponsor:
Nektar Therapeutics
Information provided by (Responsible Party):
Nektar Therapeutics
ClinicalTrials.gov Identifier:
NCT00806156
First received: December 4, 2008
Last updated: February 17, 2012
Last verified: February 2012
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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:
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 June 13, 2013