A Study of LY2624587 in Patients With Advanced Cancer

Metastatic Cancer Clinical Trial

Official title:

A Phase 1 Study of LY2624587 in Patients With Advanced Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01139788
• Other study ID #: 13740
• Secondary ID: I4N-MC-CXBA
• Status: Completed
• Phase: Phase 1
• First received: May 27, 2010
• Last updated: January 20, 2012
• Start date: June 2010
• Est. completion date: November 2011

Study information

• Verified date: January 2012
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis

Intervention

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).

Locations

Country	Name	City	State
United States	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	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recommended dose for Phase 2 studies		Baseline to study completion	Yes
Secondary	Number of participants with clinically significant effects		Baseline to cycle 12	Yes
Secondary	Radiological tumor measurement		Baseline, Cycle 1 Day-1, Cycle 2 - Day 1, Cycle 3 - Day 1	No
Secondary	Pharmacokinetics of LY2624587, area under the concentration-time curve (AUC)		Cycle 1 - Cycle 12	Yes
Secondary	Pharmacodynamic, maximum peak concentration (Cmax).		Baseline to date last subject discontinues from study drug	No