Clinical trial NCT01463631: A Study of LY3007113 in Participants With Advanced Cancer
Official title: A Phase 1 Study of LY3007113, a p38 MAPK Inhibitor, in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2011-11-02
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the safety and tolerability of different doses of an experimental treatment in participants with advanced cancer.


Eligibility criteria: Inclusion Criteria:

* Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic for which available standard therapies have failed to provide clinical benefit for their disease
* For Dose Escalation (Part A): cancer, either a solid tumor or a lymphoma
* For Dose Confirmation (Part B): cancer, either a solid tumor or a lymphoma
* Have the presence of measureable or non-measureable disease (Part A) or measureable disease (Part B) as defined by the Response Evaluation Criteria in Solid Tumors or the Revised Response Criteria for Malignant Lymphoma
* Have adequate hematologic, hepatic and renal function
* Have a performance status less than or equal to 2 on the Eastern Cooperative Oncology Group scale
* Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents
* Have an estimated life expectancy of greater than or equal to 12 weeks
* Are able to swallow capsules

Exclusion Criteria:

* Have an echocardiogram with clinically significant abnormalities
* For Dose Escalation (Part A): Have central nervous system malignancy or metastasis
* For Dose Confirmation (Part B): Have symptomatic central nervous system malignancy or metastasis
* Have an acute leukemia
* Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and stopped all therapy for that disease for a minimum of 3 years
* Have received an autologous or allogeneic stem-cell transplant within 75 days of the initial dose of study drug

Primary outcomes:
measure: Number of Participants With Clinically Significant Adverse Events (AEs) (Physical Assessments and Clinical Lab Tests)
timeFrame: Baseline through Study Completion (up to 170 Days)
Secondary outcomes:
measure: The Percentage of Participants Who Achieved a Best Response of Either Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)
timeFrame: Baseline through Study Completion (up to 170 Days)
measure: Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of Single Dose LY3007113
timeFrame: Cycle 1 Days -3, -2, -1, 1: Predose to 48 hours Postdose
measure: Pharmacokinetics: Area Under the Concentration Versus Time Curve From 0 to Tau (AUC[0-tau]) of Multiple Dose LY3007113
timeFrame: Cycle 1 Days 28 and 29, Cycle 2 Day 1: Predose to 24 hours Postdose
measure: Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3007113
timeFrame: Cycle 1 Day -3 (single dose): Predose to 48 hours Postdose; Day 28 (multiple dose): Predose to 24 hours Postdose
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: 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.
state: California
city: San Antonio
country: United States
facility: 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.
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: