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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

May 27, 2010
January 20, 2012
June 2010
November 2011   (final data collection date for primary outcome measure)
Recommended dose for Phase 2 studies [ Time Frame: Baseline to study completion ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01139788 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of LY2624587 in Patients With Advanced Cancer
A Phase 1 Study of LY2624587 in Patients With Advanced Cancer

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Cancer
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).

Experimental: LY2624587
Intervention: Drug: LY2624587
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
November 2011
November 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01139788
13740, I4N-MC-CXBA
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP