A Study of LY2584702 in Patients With Advanced Cancer

This study has been terminated.
(The pharmacokinetic properties of the molecule do not allow for further dose escalation or development.)
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01394003
First received: June 1, 2011
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

The main purpose of this trial is to determine a recommended Phase 2 dose of LY2584702 that may be safely administered to patients with advanced/metastatic cancer.


Condition Intervention Phase
Advanced Cancer
Drug: LY2584702
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of LY2584702 in Patient With Advanced or Metastatic Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Recommended dose for Phase 2 studies [ Time Frame: Baseline to study completion (approximately 41 months) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics, maximum plasma concentration (Cmax) [ Time Frame: Baseline, Cycle 1: Days 1, 2, 8, 15, and 22 ; Cycle 2: Day 2 ] [ Designated as safety issue: No ]
  • Number of patients with tumor response [ Time Frame: Baseline through Study Completion (approximately 41 months) ] [ Designated as safety issue: No ]
  • Pharmacokinetics, area under the concentration-time curve (AUC) [ Time Frame: Baseline, Cycle 1: Days 1, 2, 8, 15, and 22 ; Cycle 2: Day 2 ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: November 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2584702

Oral dose escalation starting at 25 mg, daily for 28 day cycles in Part A; oral dose escalation starting at 50 mg, twice daily for 28 day cycles in Part B; oral dose with schedule determined by Parts A and B will be administered in Part C (dose confirmation)

Patients who demonstrate clinical benefit may receive treatment beyond two (2) cycles unless one or more of the criteria for discontinuation are met.

Drug: LY2584702
administered orally

  Eligibility

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

Inclusion Criteria:

  • Have histological or cytological evidence of a diagnosis of advanced and/or metastatic cancer (solid tumors) that is refractory to standard therapy and/or therapies known to provide clinical benefit, or for which no standard therapy exists
  • Have the presence of disease amenable to efficacy assessment as defined by the Response Evaluation Criteria in Solid Tumors. Patients who have advanced non-measurable disease with elevation of a validated tumor marker may be eligible, if discussed and agreed upon by the investigator and the sponsor
  • Patients entering Part C of the study must have a tumor that is safely amenable to 2 biopsies (one pre-treatment and one on-treatment biopsy for the same tumor). Patients in Part C of the study must agree to biopsy procedures at time of consent
  • Have adequate hematologic, renal, and hepatic organ function
  • Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) scale
  • Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy (with the exception of continuing gonadotropic releasing hormone (GnRH) agonist therapy for patients with prostate cancer, or anti-estrogen therapy [for example, an aromatase inhibitor] for patients with breast cancer), or other investigational therapy for at least 3 weeks (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment and recovered from the acute effects of therapy
  • Are reliable and willing to be available for the duration of the study and are willing to follow study procedures
  • Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug
  • Females with child bearing potential must have had a negative serum pregnancy test less than or equal to 7 days prior to the first dose of study drug
  • Have an estimated life expectancy of greater than or equal to 12 weeks
  • Are able to swallow capsules

Exclusion Criteria:

  • Have received treatment within 3 weeks of the initial dose of study drug with a drug that has not received regulatory approval for any indication
  • Have 1 or more serious preexisting medical conditions that, in the opinion of the investigator, would preclude participation in this study.
  • Have symptomatic central nervous system (CNS) malignancy or metastasis. Patients with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and they are not currently receiving corticosteroids and/or anticonvulsants. Screening of asymptomatic patients without history of CNS metastasis is not required
  • Have hematologic malignancies, or lymphoma
  • Females who are pregnant or lactating
  • Have a second primary malignancy that, in the judgment of the investigator and sponsor, may affect the interpretation of results
  • Have bleeding diathesis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394003

Locations
United States, California
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.
Santa Monica, California, United States
United States, Texas
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.
San Antonio, Texas, United States
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-817-285-4559) or 1-317-615-4559 Mon-Fri 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: NCT01394003     History of Changes
Other Study ID Numbers: 12451, I3G-MC-JGCA
Study First Received: June 1, 2011
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Advanced cancer

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 15, 2014