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
| City: |
|
Newport Beach |
| State: |
|
California |
| Zip Code: |
|
92663 |
| Conditions: |
|
Tumor - Ovarian Cancer |
| 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.
|
| Study Summary: |
|
|
| Criteria: |
|
Inclusion Criteria:
1. Histologically or cytologically confirmed diagnosis of epithelial ovarian cancer,
primary peritoneal cancer or fallopian tube cancer
2. Inoperable metastatic or locally advanced ovarian cancer
3. Platinum-resistant ovarian cancer defined as progression by RECIST within 6 months of
last dose of most recent platinum drug
4. 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.
5. Diseases must be measurable as defined by RECIST in at least 1 lesion not previously
irradiated.
6. ECOG performance score of 0 or 1.
7. Adequate organ and bone marrow functions at Screening.
Exclusion Criteria:
1. 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
2. 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
3. Patients who have received CYP3A4 inducers or inhibitors.
4. Patients who have received any treatment with a camptothecin derivative (eg.
irinotecan, topotecan, SN38 investigational agents, etc.).
5. Patients with CNS metastases.
|
| NCT ID: |
|
NCT00806156 |
| Primary Contact: |
|
Study Director
Robert Medve, MD
Nektar Therapeutics
Robert Medve, MD
Phone: 415-482-5300
Email: RMedve@nektar.com
|
| Backup Contact: |
|
Email: cjue@nektar.com
Charleen Jue, BS
Phone: 415-482-5300
|
| Location Contact: |
|
Newport Beach, California 92663
United States
Katrina Lopez
Phone: 949-642-5165
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 25, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|