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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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30 April 2019 |
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Main ID: |
EUCTR2011-005197-40-DE |
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Date of registration:
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27/02/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A study comparing gemcitibine and carboplatin with or without LY2228820 for women with ovarian cancer
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Scientific title:
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A Randomized, Double-Blind, Placebo-Controlled Phase 1b/2 Study of LY2228820, a p38MAPK Inhibitor, plus Gemcitabine and Carboplatin versus Gemcitabine and Carboplatin for Women with Platinum-Sensitive Ovarian Cancer |
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Date of first enrolment:
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20/07/2012 |
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Target sample size:
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120 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005197-40 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): yes
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Australia
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Belgium
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Germany
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India
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United States
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Contacts
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Name:
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Clinical Trial Information
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Address:
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Telephone:
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Email:
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EU_Lilly_Clinical_Trials@lilly.com |
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Affiliation:
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Eli Lilly |
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Name:
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Clinical Trial Information
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Address:
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Telephone:
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Email:
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EU_Lilly_Clinical_Trials@lilly.com |
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Affiliation:
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Eli Lilly |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Women = 18 years of age
Have cytologic or histologic proven epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
Have recurrence of cancer at least 6 months after completion of first-line platinum based therapy
Phase 1b - have either measureable or non-measureable disease. Phase 2 - have at least 1 measureable lesion assessable using Response Evaluation Criteria in Solid Tumors
Have ECOG performance status = 2
Have discontinued all previous therapies for cancer at least 14 days prior to starting study. Previous radiotherapy must be discontinued at least 21 days prior to start of study
Have adequate organ function: Hematology: absolute neutrophil count = 1.5 x 10x9/L, platelets = 100 x 10x9/L, hemoglobin = 8g/dL. Hepatic: billirubin = 1.5 times upper limits of normal, alanin aminotransferase and aspartate aminotransferase = 2.5 times the upper limits of normal. Renal: calculated creatinine clearance = 50ml/min
If applicable, have a negative pregnancy test and agree to a reliable method of birth control while receiving investigational product and for 3 months following the last dose of study drug
Are able to swallow tablets
Have given written informed consent/assent prior to any study specific 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 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55
Exclusion criteria:
Are currently enrolled in another clinical trial involved in investigational drug or device
Have previously taken LY2228820Have previously been treated with gemcitabine for ovarian, fallopian tube, or primary peritoneal cancer
Receiving any cytotoxic or other cancer treatment
Have had a major bowel resection that the physician determines would alter oral drug absorption
Have a diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis)
Require concurrent administration of immunosupressive therapy
Intermittent corticosteroids used as part of an antiemetic regimen are permitted.
Have known central nervous system malignancy or metastasis
Have a concurrent or previous malignancy, unless that prior malignancy was treated with definitive therapy at least 5 years previously with no evidence of recurrence.
Have serious concomitant systemic disorders incompatible with the study
Have received more than one previous chemotherapy regimen for ovarian cancer
Have any diagnosis of ovarian borderline tumor
Are pregnant or lactating women
Are receiving concurrent therapy that the physician determines is immunosuppressive
Have known central nervous system malignancy or metastasis
Have a concurrent or previous malignancy, unless that prior malignancy was treated with definitive therapy at least 5 years previously with no evidence of recurrence.
Have a serious systemic disorder that the physician determines is incompatible with the study
Have received more than one previous chemotherapy regimen for ovarian cancer
Have tumor of borderline malignancy
Are pregnant or lactating women
Age minimum:
Age maximum:
Gender:
Female: yes
Male: no
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cancer [C04]
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Epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer
MedDRA version: 19.0
Level: PT
Classification code 10066697
Term: Ovarian cancer recurrent
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Intervention(s)
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Product Name: LY2228820
Product Code: LY2228820
Pharmaceutical Form: Tablet
Current Sponsor code: LY2228820
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Carboplatin
Pharmaceutical Form:
INN or Proposed INN: CARBOPLATIN
CAS Number: 41575-94-4
Product Name: Gemcitabine
Pharmaceutical Form:
INN or Proposed INN: GEMCITABINE
CAS Number: 95058-81-4
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Primary Outcome(s)
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Secondary Objective: 1. Change in tumor size, CA 125, overall response rate, overall survival
2. Safety and tolerability of the combination of LY2228820 with gemcitabine and carboplatin
3. Pharmacokinetics (PK) of LY2228820 and evaluation for effect of LY2228820 on the PK of gemcitabine, its metabolite (dFdU), and carboplatin
4. Biomarkers related to the p38 MAPK pathway activity and the pathogenesis of ovarian cancer
5. Patient-reported outcomes
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Main Objective: Phase 1b - to determine the recommended Phase 2 dose of LY2228820 that can be safely administered with gemcitabine and carboplatin
Phase 2 - to compare the progression-free survival in patients treated with LY2228820 plus gemcitabine and carboplatin versus placebo plus gemcitabine and carboplatin
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Primary end point(s): Phase 1b – Safety and dose
Phase 2 – Progression free survival.
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Timepoint(s) of evaluation of this end point: Phase 1b - after all evaluable patients have received at least 1 cycle of study treatment
Phase 2 - after 79 PFS events have occurred
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Phase 1b: N/A
Phase II: After 30 patients in have received 1 cycle of study
therapy, after 60 patients have received at least 2 cycles of
therapy, and final analysis is 2 years after completion of
enrollment.
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Secondary end point(s): Change in tumor size, CA125, overall response rate, overall survival
Safety and tolerability of the combination of LY2228820, gemcitabine, and carboplatin
Pharmacokinetics of LY2228820, gemcitabine and its metabolite (dFdU), and carboplatin
Biomarkers related to p38 MAPK pathway activity and the pathogenesis of ovarian cancer
Patient-reported outcomes
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Secondary ID(s)
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I1D-MC-JIAE
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Source(s) of Monetary Support
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Eli Lilly and Company
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Ethics review
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Status: Approved
Approval date:
Contact:
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