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 Locally Advanced Cervical Cancer
- Conditions
- Patients with Metastatic or Locally Advanced Cervical CancerMedDRA version: 9.1 Level: LLT Classification code 10008229 Term: Cervical cancer
- Registration Number
- EUCTR2008-005578-12-GB
- Lead Sponsor
- ektar Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 70
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 years old
3)Histologically or cytologically confirmed cervical cancer
4)Inoperable metastatic or locally advanced disease
5)Patients must not have received prior chemotherapy given in the metastatic / locally advanced setting; one prior concomitant chemotherapy regimen is permissible provided it did not include a camptothecin
6)Measurable disease as defined by RECIST in at least one lesion not previously irradiated
7)Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
8)Patients must have adequate organ and bone marrow function at the screening visit as defined below
a Absolute neutrophil count = 1,500/mm3 without GCSF support for 21 days preceding the lab assessment
b White blood cell (WBC) count = 3,000/mm3 without GCSF 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 within 7 days preceding the lab assessment
e Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) = 3 × upper limit of normal (ULN) (= 5 × ULN if the presence of liver metastasis is confirmed). Bilirubin must be within normal limits.
f Serum creatinine = 1.5 times ULN or creatinine clearance = 60 mL/min
g Albumin = 3 g/dL (30 g/L)
9)Patients who are women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at the predose visit of each cycle
10)Patients who are women of childbearing potential, or men whose female partners are of childbearing potential, must agree to use at least 2 forms of contraception, 1 of which includes a barrier method by the male partner, during the treatment period and for at least 3 months after the last dose of the study drug
11)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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients who meet any of the following criteria will not be permitted entry to the study:
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 must have, as determined by the Investigator, recovered to CTC Grade 1 toxicity (any CTC grade of alopecia is allowed) 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
3)Administration of any of the following cytochrome P450 3A4 (CYP3A4) inducer or inhibitor: phenytoin, phenobarbital, carbamazepine, rifampin, rifabutin, St. John’s Wort, ketoconazole, neuromuscular agents or atazanavir sulfate (Section 8.6.2) within 2 weeks prior to the first day of study drug treatment
4)Patients who have been treated with an investigational agent within 4 weeks prior to Day 1 of Cycle 1
5)Prior treatment with a camptothecin
6)Concomitant use of biological agents including growth factors
7)Known or suspected central nervous system metastases
8)Pregnant or lactating
9)Other malignancy within the past 3 years except for any of the following: non-melanoma skin cancer, or any another malignancy with no evidence of recurrence for more than 5 years
10)Any other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation
11)Patients with a history of hypersensitivity to other PEGylated drugs
12)Patients with inflammatory bowel disease
13)Patients with unresolved bowel disease
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