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 Unresectable Locally Advanced Platinum-Resistant Ovarian Cancer
- Conditions
- Metastatic or Unresectable Locally Advanced Platinum-Resistant Ovarian CancerMedDRA version: 14.0Level: PTClassification code 10057529Term: Ovarian cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2008-005576-26-BE
- Lead Sponsor
- ektar Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 178
Each patient must meet the following criteria to be enrolled in this study:
1. Provide signed and dated informed consent prior to study-specific screening procedures
2. = 18-year old females
3. Histologically or cytologically confirmed diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer
4. Inoperable metastatic or unresectable locally advanced disease
5. Platinum-resistant ovarian cancer defined as progression by RECIST within 6 months of last dose of most recent platinum drug
6.Platinum-resistant patients who have progressed after receiving PLD
therapy in a platinum-resistant setting or who are otherwise unable to
receive PLD therapy
7. Patients must have measurable disease as defined by RECIST (version 1.0) in at least 1 lesion not previously irradiated
8. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
9. Patients must have adequate organ and bone marrow function at the Screening visit as defined below:
a. Absolute neutrophil count = 1,500/mm3 without myeloid growth factor support for 21 days preceding the lab assessment,
b. White blood cell (WBC) count = 3,000/mm3 without myeloid growth factor support for 21 days preceding the lab assessment,
c. Platelet count = 100,000/mm3, without transfusion within 7 days preceding the lab
assessment,
d. Hemoglobin = 9 g/dL, without transfusion support ,
e. Total bilirubin = 2 mg/dL,
f. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) = 3 × ULN (= 5 × ULN if the presence of liver metastasis is confirmed), and
g. Serum creatinine = 1.5 times ULN or creatinine clearance = 60 mL/min.
10. Women of childbearing potential must have a negative serum pregnancy test at Screening
11. Women of childbearing potential must agree to use at least 2 forms of contraception, 1 of which includes a barrier method (male condom) by the male partner, during the study drug treatment period and for at least 8 months after the last dose of the study drug
12. Patients must be able and willing to comply with the study visit schedule and study procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35
1. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to Day 1 of Cycle 1, and have not recovered to Grade 1 toxicity as defined by NCI-CTCAE version 3.0 (with any grade of alopecia allowed) and Grade 0 diarrhea associated with previous treatments irrespective of the interval from the last treatment
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. Minor surgery does not include placement of a venous access device or
simple ascites drain
3. Administration of any of the following cytochrome P450 3A4 (CYP3A4) inducers or inhibitors: phenytoin, phenobarbital, carbamazepine, rifampin, rifabutin, St. John’s Wort, ketoconazole, neuromuscular agents or atazanavir sulfate within 2 weeks prior to the first day of study drug treatment
4. Patients who are receiving biologic agents including antibodies (eg, bevacizumab,
trastuzumab, etc.) as well as investigational agents, within 28 days of Cycle 1 Day 1
5. Patients who have received any treatment with a camptothecin derivative (eg, irinotecan, topotecan, SN38 investigational agents, etc.)
6. Known or suspected central nervous system metastases
7. Pregnant or lactating
8. Other malignancy within the past 5 years except for any of the following: early-stage (= IB),
low-grade (FIGO Grade 1 or 2) endometrial cancer, non-melanoma skin cancer, or carcinoma in situ of the cervix
9. Any other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation
10. Patients with a history of hypersensitivity to other PEGylated drugs
11. Patients with inflammatory bowel disease (eg, Crohn’s disease and ulcerative colitis), unresolved bowel issues (eg, diverticulitis, ileitis, colitis, complete bowel obstruction etc.) or patients with chronic or acute gastrointestinal disorders with diarrhea as a major symptom
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method