A Study of LY2624587 in Patients With Advanced Cancer
This study has been completed.
Sponsor:
Eli Lilly and Company
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
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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
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 Neoplasms Neoplasms, Second Primary Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on June 17, 2013