Metastatic CancerPhase 1NCT01139788
A Study of LY2624587 in Patients With Advanced Cancer
A Phase 1 study testing LY2624587 in people with Metastatic Cancer, run by Eli Lilly and Company at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- LY2624587
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2010to Nov 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
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, 78229
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, 85258
About this study
Official title: 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.
- Conditions
- Metastatic Cancer
- Being tested
- LY2624587
- Keywords
- Cancer
- Medical subject headings
- Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2624587Drug
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).
| Study group | Role | What they receive |
|---|---|---|
| LY2624587 | Experimental | Not described Receives: Drug: LY2624587 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended dose for Phase 2 studies
Measured: Baseline to study completion
Secondary outcomes (4)
Number of participants with clinically significant effects
Measured: Baseline to cycle 12
Radiological tumor measurement
Measured: Baseline, Cycle 1 Day-1, Cycle 2 - Day 1, Cycle 3 - Day 1
Pharmacokinetics of LY2624587, area under the concentration-time curve (AUC)
Measured: Cycle 1 - Cycle 12
Pharmacodynamic, maximum peak concentration (Cmax).
Measured: Baseline to date last subject discontinues from study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139788
- Sponsor's protocol ID
- 13740
- Other IDs
- I4N-MC-CXBA
- Status last verified
- Jan 2012
- First submitted
- 27 May 2010
- Last updated
- 24 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of LY2624587 in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT01139788
- Acronym / sponsor ID
- 13740
- Conditions
- Metastatic Cancer
- Keywords
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 9 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LY2624587 | Experimental | Drug: LY2624587 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY26245876-900 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). | Drug | LY2624587 |
Primary outcome
Recommended dose for Phase 2 studies
Time frame: Baseline to study completion
4 secondary outcomes
Number of participants with clinically significant effects
Time frame: Baseline to cycle 12
Radiological tumor measurement
Time frame: Baseline, Cycle 1 Day-1, Cycle 2 - Day 1, Cycle 3 - Day 1
Pharmacokinetics of LY2624587, area under the concentration-time curve (AUC)
Time frame: Cycle 1 - Cycle 12
Pharmacodynamic, maximum peak concentration (Cmax).
Time frame: Baseline to date last subject discontinues from study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY2624587 in people with Metastatic Cancer, run by Eli Lilly and Company at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended dose for Phase 2 studies (time frame: Baseline to study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2012.