Cancer, Ovarian Cancer, Solid Tumor
Conditions
Keywords
Cancer, Neoplasms, Solid Tumor, Ovarian Cancer, Solid Malignancies
Brief summary
This study will assess the effect of IT-101 on delaying cancer progression in patients with platinum sensitive ovarian cancer.
Interventions
DRUGIT-101 (12mg/m2/dose)
Patients who satisfy the inclusion/exclusion criteria will receive a blinded infusion of IT-101 (12mg/m2/dose) every other week until disease progression.
DRUGIT-101 (15mg/m2/dose)
Patients who satisfy the inclusion/exclusion criteria will receive an infusion of IT-101 (15mg/m2) every other week until disease progression.
DRUG5% Dextrose (Placebo)
Patients who satisfy the inclusion/exclusion criteria will receive an infusion of placebo every other week until disease progression.
Sponsors
NewLink Genetics Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 78 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Women between the age of 18 and 78, inclusive; * Evidence of platinum-sensitive ovarian cancer following the patient's primary treatment(\>= 6 months); * Received a 2nd line platinum-based chemotherapy regimen (4-6 cycles) without evidence of progression; * May have measurable or unmeasurable disease; * Eastern Cooperative Oncology Group (ECOG) 0 or 1; * Ability to understand and the willingness to sign a written informed consent document. Key
Exclusion criteria
* Women who are pregnant or lactating; * Prior treatment with a topoisomerase inhibitor; * Patients with unacceptable organ and/or hematologic reserve at screening; * Urine protein of \> 500 mg/day or active nephropathy; * Electrocardiogram (ECG) with evidence of clinically significant conduction abnormalities or active ischemia as determined by the investigator; * History of pancreatitis within the last 12 months; * Patients treated with previous high dose chemotherapy or stem cell transplant within the last 5 years; * Use of any investigational agents within 4 weeks of study enrollment; * Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, psychiatric illness or other co-morbidity that presents a risk to the patient as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To Compare the proportion of patients without evidence of disease progression at 30 weeks following randomization between IT-101 at 12 mg/m2/dose or 15 mg/m2/dose to a placebo infusion treatment administered every other week. | 30 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of adverse drug experiences between each treatment | 30 weeks |
| Compare the frequency of drug-related toxicities between each treatment arm | 30 weeks |
| Compare Quality of Life (QOL, patient-reported) measures (FACT-O, FOSI) between treatment arms. | 30 weeks |
Countries
United States
Outcome results
None listed