Patients with Metastatic or Locally Advanced Cervical Cancer MedDRA version: 9.1 Level: LLT Classification code 10008229 Term: Cervical cancer
Conditions
Interventions
Product Name: PEG-Irinotecan
Product Code: NKTR-102
Pharmaceutical Form: Powder for solution for infusion
Current Sponsor code: NKTR-102
Sponsors
Nektar Therapeutics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the objective response rate (ORR) with NKTR-102 given on one of two schedules: once every 14 days (q14d) and once every 21 days (q21d); Secondary Objective: For each schedule: • To estimate progression-free survival (PFS) with NKTR-102 • To evaluate overall survival (OS) rates with NKTR-102 • To characterize the safety profile of NKTR-102 • To monitor the pharmacokinetics of NKTR-102 and its metabolites in a subset of patients ; Primary end point(s): For each schedule: • Objective response rate as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) | — |
Countries
United Kingdom
Outcome results
None listed