Phase 1b: Metastatic Cancer Phase 2: Advanced or Metastatic Unresectable Pancreatic Cancer
Conditions
Interventions
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
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 185
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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;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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Belgium, Canada, Germany, Italy, Spain, United States
Contacts
Public ContactClinical Trial Information
Eli Lilly and Company
Outcome results
None listed