A Study of LY3039478 in Participants With Advanced Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01695005
First received: September 24, 2012
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to find a recommended dose level of LY3039478 that can safely be taken by participants with advanced cancer or cancer that has spread to other parts of the body, including but not limited to lymphoma. The study will also explore changes to various markers in blood cells and tissue. Finally, the study will help to document any tumor activity this drug may have.


Condition Intervention Phase
Neoplasms
Neoplasm Metastasis
Lymphoma
Drug: LY3039478
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of LY3039478 in Patients With Advanced or Metastatic Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline to disease progression or participant discontinuation (estimated 8 -12 weeks) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics: Maximum Concentration (Cmax) of LY3039478 [ Time Frame: Predose up to 30 hours post dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY3039478 [ Time Frame: Predose up to 30 hours post dose ] [ Designated as safety issue: No ]
  • Number of Participants with Tumor Response [ Time Frame: Baseline to disease progression or participant discontinuation (estimated 8 -12 weeks) ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: October 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY3039478 - Dose Escalation
Part A: LY3039478 administered orally three times per week (TIW) at escalating doses (2.5 milligrams [mg] to 100 mg) for two 28 day cycles. Participants receiving benefit may continue until disease progression
Drug: LY3039478
Administered orally
Experimental: LY3039478 - Cohort Expansion
Part B: LY3039478 administered orally three times per week (TIW) at a fixed dose determined in Part A for two 28 day cycles. Participants have a defined alteration in a certain molecular pathway. Participants receiving benefit may continue until disease progression.
Drug: LY3039478
Administered orally

Detailed Description:

In Part A of this study, participants with advanced/metastatic cancer (including lymphoma) will receive increasing doses of LY3039478 to define the dose level for Part B. In Part B, LY3039478 will be explored at a predefined fixed dose level. Participants in Part B must have a defined alteration in a certain molecular pathway. Enrollment of participants in Part B will start once Part A is completed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • For all parts: The participant must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed to provide clinical benefit for their advanced or metastatic cancer.
  • For Dose Escalation (Part A): The participant must have histological or cytological evidence of cancer, either a solid tumor or a lymphoma, which is advanced or metastatic.
  • For Dose Confirmation (Part B): All participants must have a histological evidence of their advanced or metastatic cancer and prescreened alterations in a defined pathway such as mutations, amplification or gene expressions related to the defined pathway.
  • As defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), the Revised Response Criteria for Malignant Lymphoma or the Response Assessment in Neuro Oncology (RANO) criteria for glioblastoma:

    • For Dose Escalation (Part A): Have measurable or nonmeasurable disease.
    • For Dose Confirmation (Parts B): Have measurable disease or reliable biomarker measure (example prostate-specific antigen [PSA], cancer antigen 125 [CA125]).
  • Have adequate organ function including:

    • Hematologic: Absolute neutrophil count (ANC) at least 1.5 x 109/Liter (L), platelets at least 100 x 109/L, and hemoglobin at least 8 grams per deciliter (g/dL). Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator; however, initial study drug treatment must not begin earlier than the day after the erythrocyte transfusion.
    • Hepatic: Bilirubin no more than 1.5 times upper limits of normal (ULN) and alanine aminotransferase (ALT) no more than 2.5 times ULN. If the liver has tumor involvement, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) equaling 5 times ULN are acceptable.
    • Renal: calculated creatinine clearance at least 45 milliliters per minute (mL/min)
  • Have a performance status of less than or equal to 1 on the Eastern Cooperative Oncology Group (ECOG) scale and life expectancy of more than 12 weeks.
  • Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and investigational therapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (treatment-related toxicity resolved to baseline) except for residual alopecia. At the discretion of the investigator, participants with breast or prostate cancers progressing on therapies may have that treatment continued while receiving study drug.

Exclusion Criteria:

  • Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively.
  • Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (for example, inflammatory bowel disease or history of major surgical resection involving the stomach or small bowel).
  • Have central nervous system (CNS) malignancy, except:

    • Participants with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids and/or anticonvulsants, and their disease is asymptomatic and radiographically stable for at least 60 days (screening not required).
    • Participants with glioblastoma are eligible.
  • Have an acute leukemia.
  • Have received an autologous or allogeneic stem-cell transplant.
  • Females who are pregnant or lactating.
  • Have active bacterial, fungal, and/or known viral infection (for example, human immunodeficiency virus [HIV] antibodies, hepatitis B surface antigen [HBSAg], or hepatitis C antibodies). Screening is not required for enrollment.
  • Have malabsorptive syndromes, enteropathies, gastroenteritis (acute or chronic), or diarrhea (acute or chronic).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695005

Contacts
Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) 1-317-615-4559

Locations
United States, Florida
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Not yet recruiting
Miami, Florida, United States, 33136
Contact: Eli Lilly         
United States, Michigan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Eli Lilly         
United States, New York
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Not yet recruiting
New York, New York, United States, 10032
Contact: Eli Lilly         
Denmark
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Kobenhavn, Denmark, 2100
Contact: Eli Lilly         
France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Paris, France, 75248
Contact: Eli Lilly         
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Villejuif, France, 94805
Contact: Eli Lilly         
Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Not yet recruiting
Tübingen, Germany, 72076
Contact: Eli Lilly         
Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Barcelona, Spain, 08035
Contact: Eli Lilly         
United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Not yet recruiting
London, England, United Kingdom, SE1 9RT
Contact: Eli Lilly         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01695005     History of Changes
Other Study ID Numbers: 14547, I6F-MC-JJCA
Study First Received: September 24, 2012
Last Updated: August 11, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Neoplasms
Lymphoma
Neoplasm Metastasis
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014