patients with epithelial ovarian cancer who have received no more than 2 prior systemic treatment regimens for platinum-resistant disease. MedDRA version: 6.1 Level: PT Classification code 10061328
Conditions
Interventions
Product Name: LY573636
Pharmaceutical Form: Powder for infusion*
CAS Number: 519055-63-1
Current Sponsor code: LY573636
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numb
Sponsors
ELI LILLY
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Patients must have a diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer that is not amenable to curative therapy. [2] Patients must have platinum-refractory or platinum-resistant disease: Platinum-refractory: failure to achieve at least a partial response to first-line platinum-based therapy (Markman and Bookman 2000). Platinum-resistant: progression in = 2X upper limit of normal (Rustin 2003), if they have otherwise nonmeasurable disease as defined by the RECIST guidelines (these patients are referred to as ?isolated CA-125 recurrence,? for purposes of this study). [5] For patients with prior radiation therapy: treatment to less than 25% of marrow-bearing area, completed at least 2 weeks prior to study enrollment. Patients must have recovered from the acute toxic effects of the treatment. [6] Are at least 18 years of age. [7] Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale (see Attachment JZAG.3). [8] Patients must have an estimated life expectancy of >=3 months. [9] Must have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, hormone therapy, or other investigational therapy for at least 30 days (6 weeks for mitomycin-C or nitrosoureas) before study enrollment and recovered from the acute effects of therapy (except alopecia). [10] Have adequate organ function including: ? Bone Marrow Reserve: Absolute neutrophil count (ANC) >=1.5 x 109/L prior to treatment, platelets >=100 x 109/L, and hemoglobin >=8 g/dL (transfusions are not allowed to reach 8 g/dL prior to enrollment). ? Hepatic: Bilirubin =30 g/L or 3.0 g/dL. [12] Patients with reproductive potential should use medically approved contraceptive precautions during the trial and for 6 months following the last dose of study drug. [13] Exhibit patient compliance and geographic proximity that allow for adequate follow-up. [14] Have given written informed consent approved by Lilly and the ethical review board (ERB)/institutional review board (IRB) governing the site. 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: [15] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. [16] Have received more than 2 lines of systemic therapy for platinumrefractory/ resistant disease. Neoadjuvant therapy is not counted as a previous systemic regimen for purposes of determining eligibility for this study. [17] Require regular, periodic paracentesis. [18] Patients with documented central nervous system or leptomeningeal metastasis (brain metastasis) at the time of study entry. Patients with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before study entry to rule out occult brain metastasis. [19] Patients with serious concomitant disorders, including active bacterial, fungal, or viral infection, incompatible with the study (at the discretion of the investigator). [20] Patients with a second primary malignancy that could affect interpretation of the results. NOTE: Patients with adequately treated carcinoma of the skin (excluding melanoma) and patients with a prior history of malignancy who have been disease-free for more than 2 years are eligible. [21] Patients with serious preexisting medical conditions (at the investigator?s discretion). [22] Patients with electrocardiogram (ECG) abnormalities including QTC >470 msec. [23] Patients actively receiving warfarin (Coumadin) therapy for treatment of venous thrombosis or other prothrombotic conditions. NOTE: Patients receiving low dose (1 mg daily) warfarin will be allowed in this study. For those patients, more frequent monitoring of PT (INR)/aPTT will be required. [24] Persons who have previously completed or withdrawn from this study or any other study investigating LY573636. [25] Women who are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the objective response rate (complete response [CR] and partial response [PR]) for LY573636 in patients with epithelial ovarian cancer who have received no more than 2 prior systemic treatment regimens for platinum-resistant disease.;Secondary Objective: The secondary objectives are: ? to characterize the progression-free survival distribution ? to estimate the clinical benefit rate (CR+PR+stable disease) ? to evaluate the pharmacokinetics of LY573636 using a limited sampling methodology in this population ? to estimate time-to-event variables, such as overall survival time, duration of overall objective response, and duration of stable disease ? to evaluate the safety of LY573636 in this patient population.;Primary end point(s): The primary objective of this study is to determine the objective response rate (complete response [CR] and partial response [PR]) for LY573636 in patients with epithelial ovarian cancer who have received no more than 2 prior systemic treatment regimens for platinum-resistant disease. | — |
Countries
Italy
Outcome results
None listed