A Study of LY2624587 in Patients With Advanced Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01139788
First received: May 27, 2010
Last updated: January 20, 2012
Last verified: January 2012
  Purpose

Study CXBA is a multicenter nonrandomized, dose escalation, open-label, Phase 1 study of intravenous LY2624587 in patients with advanced or metastatic cancer for which no treatment of higher priority exists.


Condition Intervention Phase
Metastatic Cancer
Drug: LY2624587
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of LY2624587 in Patients With Advanced 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of participants with clinically significant effects [ Time Frame: Baseline to cycle 12 ] [ Designated as safety issue: Yes ]
  • Radiological tumor measurement [ Time Frame: Baseline, Cycle 1 Day-1, Cycle 2 - Day 1, Cycle 3 - Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetics of LY2624587, area under the concentration-time curve (AUC) [ Time Frame: Cycle 1 - Cycle 12 ] [ Designated as safety issue: Yes ]
  • Pharmacodynamic, maximum peak concentration (Cmax). [ Time Frame: Baseline to date last subject discontinues from study drug ] [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: June 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2624587 Drug: LY2624587

6-900 mg, administered intravenously, weekly for a minimum of one (1) 28 day cycle.

If patients are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days).


  Eligibility

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

Inclusion Criteria:

  • Present with histological or cytological evidence of a diagnosis of cancer (solid tumors, lymphoma, or chronic lymphocytic leukemia) that is advanced and/or metastatic. The patient must be, in the judgement of the investigator, an appropriate candidate for experimental therapy after available standard therapies have been used.
  • Have the presence of measurable or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST), Revised International Working Group Lymphoma Response Criteria, or National Cancer Institute Working Group Guidelines for Chronic Lymphocytic Leukemia.
  • Have adequate organ function.
  • Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) scale.
  • 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 discontinued chemotherapy and cancer-related hormonal therapy with commercially-available agents for at least 21 days (6 weeks for mitomycin-C or nitrosoureas) and radiotherapy for at least 14 days prior to study enrollment and recovered from the acute effects of therapy (less than or equal to National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE v 4.02; Grade 1). Hormone refractory prostate cancer patients receiving gonadotropin releasing hormone (GnRH) agonist therapy or breast cancer patients on anti-estrogen therapy (for example, an aromatase inhibitor) prior to entrance on the study may have that treatment continued while they are enrolled in Study CXBA.
  • Have an estimated life expectancy of greater than or equal to 12 weeks.

Exclusion Criteria:

  • Have received treatment with an investigational drug, which has not received regulatory approval for any indication, within 28 days of study treatment with LY2624587.
  • Have medical conditions that, in the opinion of the investigator, would preclude participation in this study.
  • Have symptomatic central nervous system 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 metastases is not required.
  • Have a history of major organ transplant.
  • Have current acute leukemia.
  • Have active human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C antibodies.
  • Have QTc greater than 470 msec (female) or greater than450 msec (male), history of congenital long QT syndrome or other conduction abnormality.
  • Have had an autologous or allogenic bone marrow transplant.
  • Previously treated with a CXCR4 antagonist, or have had a significant allergy to biologic agents.
  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: NCT01139788

Locations
United States, Arizona
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.
Scottsdale, Arizona, United States, 85258
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, 78229
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hour EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01139788     History of Changes
Other Study ID Numbers: 13740, I4N-MC-CXBA
Study First Received: May 27, 2010
Last Updated: January 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Cancer

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014