Main
|
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. |
Register:
|
EUCTR |
Last refreshed on:
|
20 February 2017 |
Main ID: |
EUCTR2011-000211-64-ES |
Date of registration:
|
30/08/2011 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
This is an open-label, multicenter, nonrandomized Phase 1b study of oral administration of LY2157299 in combination with gemcitabine followed by a randomized, double-blind, Phase 2 study of oral administration of LY2157299 in combination with gemcitabine versus gemcitabine plus placebo
|
Scientific title:
|
A Phase 1b/2 Study with Gemcitabine and LY2157299 for Patients with Metastatic Cancer (Phase 1b) and Advanced or Metastatic Unresectable Pancreatic Cancer (Phase 2) |
Date of first enrolment:
|
26/07/2011 |
Target sample size:
|
168 |
Recruitment status: |
Not Recruiting |
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-000211-64 |
Study type:
|
Interventional clinical trial of medicinal product |
Study design:
|
Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 2
|
Phase:
|
Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
|
|
Countries of recruitment
|
Belgium
|
Canada
|
Germany
|
Italy
|
Spain
|
United States
| | |
Contacts
|
Name:
|
Clinical Trial Information
|
Address:
|
Lilly Corporate Center
46285
Indianapolis, Indiana
United States |
Telephone:
|
+ 1 317 277 6494 |
Email:
|
EU_Lilly_Clinical_Trials@lilly.com |
Affiliation:
|
Eli Lilly and Company |
|
Name:
|
Clinical Trial Information
|
Address:
|
Lilly Corporate Center
46285
Indianapolis, Indiana
United States |
Telephone:
|
+ 1 317 277 6494 |
Email:
|
EU_Lilly_Clinical_Trials@lilly.com |
Affiliation:
|
Eli Lilly and Company |
| |
Key inclusion & exclusion criteria
|
Inclusion criteria: Ph1b: Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic disease; that is refractory to standard therapy and/or therapies known to provide clinical benefit or for which no standard therapy exists; and/or in which gemcitabine therapy at the proposed doses and schedule would be considered appropriate treatment for the metastatic disease (eg, pancreatic cancer) Ph 2: Have histological or cytological diagnosis of adenocarcinoma of the pancreas that is locally advanced (Stage II, III) or metastatic (Stage IV) and not amenable to resection with curative intent. Patients with previous radical surgery for pancreatic cancer are eligible after progression is documented. If they received adjuvant chemotherapy or chemoradiotherapy with gemcitabine, they can be enrolled if the treatment was completed 3 months before or longer. Ph 2: Tumor tissue or unstained slides are available from original biopsy or resection or other tumor biopsies. Have measurable disease or non-measurable disease, defined according to RECIST Males or females at least 18 years of age. Have given written informed consent prior to any study-specific procedures Have adequate organ function Have a performance status of ?2 on the Eastern Cooperative Oncology Group Ph 1b: Patients may have received prior chemotherapy, radiotherapy, cancer-related hormone therapy, or other investigational therapy as treatment There is no limit in the number of previous lines of therapy Ph 2: Patients may have received previous adjuvant treatment with gemcitabine with or without radiotherapy for pancreatic cancer Adjuvant treatment must have finished at least 6 months before enrolling Ph1b & 2: patients must have recovered from any Grade 3/4 toxicities of previous therapies Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures Prior radiation therapy for treatment of cancer is allowed to <25% of the bone marrow (Cristy and Eckerman 1987), and patients must have recovered from the acute toxic effects of their treatment prior to study enrollment. Prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed at least 4 weeks before study entry. Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate, during and for 3 months after discontinuation of study treatment. Women of childbearing potential must have a negative beta-human chorionic gonadotropin pregnancy test documented within 14 days prior to treatment. If condoms are used as a barrier contraceptive, a spermicidal agent should be added to ensure that pregnancy does not occur. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 185 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 185
Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria: Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or nonapproved use of a drug or device (other than the investigational product used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Have moderate or severe cardiac disease Are unable to swallow tablets or capsules. Are pregnant or breastfeeding. Have any significant medical illnesses that, in the investigator?s opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient?s ability to tolerate this therapy. Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ), unless in complete remission and off of all therapy for that disease for a minimum of 3 years. Have active infection that would interfere with the study objectives or influence study compliance. Ph 2 only: Endocrine pancreatic tumors or ampullary cancer. Patients with acute or chronic leukemia or with any other disease likely to have a significant bone marrow infiltration (screening not required). Have previously completed or withdrawn from this study or any other study investigating LY2157299 or any other TGF-ß inhibitor. Have known allergy to LY2157299 or gemcitabine or any ingredient of LY2157299 or gemcitabine formulations. Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
|
Health Condition(s) or Problem(s) studied
|
Phase 1b: Metastatic Cancer
Phase 2: Advanced or Metastatic Unresectable Pancreatic Cancer
|
Therapeutic area: Diseases [C] - Cancer [C04]
|
Intervention(s)
|
Product Name: LY2157299 Product Code: LY2157299 Pharmaceutical Form: Coated tablet INN or Proposed INN: LY2157299 monohydrate CAS Number: 924898-09-9 Current Sponsor code: LY2157299 Other descriptive name: LY2157299 monohydrate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80- INN or Proposed INN: LY2157299 monohydrate CAS Number: 924898-09-9 Current Sponsor code: LY2157299 Other descriptive name: LY2157299 monohydrate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 160- INN or Proposed INN: LY2157299 monohydrate CAS Number: 924898-09-9 Current Sponsor code: LY2157299 Other descriptive name: LY2157299 monohydrate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
Trade Name: Gemzar 1000 mg Product Name: Gemzar Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: GEMCITABINE HYDROCHLORIDE CAS Number: 122111-03-9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1000-
|
Primary Outcome(s)
|
Secondary Objective: Phase 1b: - To assess PK profile of LY2157299 when administered together with gemcitabine - To document any antitumor activity observed after administration of LY2157299 and gemcitabine - To explore biomarker responses associated with LY2157299 and gemcitabine combination Phase 2: - To compare LY2157299 combined with gemcitabine to gemcitabine plus placebo - To evaluate tolerability profile of LY2157299 when administered in combination with gemcitabine - To evaluate the PK profile of LY2157299 - To compare LY2157299 combined with gemcitabine to gemcitabine combined with placebo with regard to biomarker responses
|
Primary end point(s): Phase 1b: to detremine a safe tolerable dose for phase 2
Phase 2: Overall survival
|
Main Objective: Phase 1b: To determine a safe/tolerable Phase 2 dose of LY2157299 for combination with gemcitabine in patients with solid malignancy, who failed previous approved therapies and/or are amenable to gemcitabine therapy (eg, pancreatic cancer, biliary tract, sarcoma). Phase 2: To compare overall survival (OS) in patients with Stage II-IV unresectable pancreatic cancer when treated with the combination of LY2157299 and gemcitabine with that of gemcitabine plus placebo.
|
Timepoint(s) of evaluation of this end point: Phase 1b: 1 cycle of LY2157299 tretament (i.e 4 weeks)
Phase 2: patient death (study anticipates Phase 2 patients will be in the study @ 6 months)
|
Secondary Outcome(s)
|
Secondary end point(s): define LY2157299 pharmacokinetics, investigate efficacy
|
Timepoint(s) of evaluation of this end point: PK 4weeks efficacy - 8 weeks or until pt withdraws
|
Secondary ID(s)
|
H9H-MC-JBAJ
|
Source(s) of Monetary Support
|
Eli Lilly and Company
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|