Advanced CancerPhase 1NCT01214629
A Study for Participants With Advanced Cancer
A Phase 1 study testing LY2523355 and pegfilgrastim in people with Advanced Cancer and Metastatic Cancer, run by Eli Lilly and Company at 2 sites in United States.
Trial summary
This study is being conducted to determine the safety of LY2523355 for the treatment of advanced and/or metastatic cancer (including Non-Hodgkin's lymphoma). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Metastatic Cancer
- What is being tested?
- LY2523355 and pegfilgrastim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2007to May 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Have a diagnosis of advanced and/or metastatic cancer (solid tumors or Non-Hodgkin's lymphoma) that is refractory to standard therapy or for which no proven effective therapy exists. Participants entering Part B of the study must also have a tumor that is safely amenable to serial biopsies
- Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST, Therasse et al. 2000) or Revised International Working Group Lymphoma Response Criteria (Cheson et al. 2007)
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
- Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 28 days (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment
- 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 urine or serum pregnancy test less than or equal to 7 days prior to the first dose of study drug
- Have an estimated life expectancy of greater than or equal to 12 weeks
Who cannot join
- Have symptomatic, untreated or uncontrolled central nervous system (CNS) metastases. Participants 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 participants without history of CNS metastases is not required
- Have current acute or chronic leukemia
- Have had an autologous or allogenic bone marrow transplant
- Have the following conduction abnormalities: PR >250 milliseconds (msec), second degree or complete atrioventricular (AV) block, intraventricular conduction delay (IVCD) with QRS ≥120 msec, left branch bundle block (LBBB), right branch bundle block (RBBB), Wolf-Parkinson- White syndrome (WPW), left anterior fascicular block (LAFB), left posterior fascicular block (LPFB), or other conduction abnormality that in the opinion of the investigator would preclude safe participation in this study.
- Females who are pregnant or lactating
- Known hypersensitivity to pegfilgrastim or filgrastim
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.
Albuquerque, New Mexico, 87131
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.
Philadelphia, Pennsylvania, 19111
About this study
Official title: A Phase I Study of LY2523355 in Patients With Advanced Cancer
This study is being conducted to determine the safety of LY2523355 for the treatment of advanced and/or metastatic cancer (including Non-Hodgkin's lymphoma).
Read the detailed description
This study is a multi-center, non-randomized, open label, dose-escalation, Phase 1 study of intravenous LY2523355 in participants with advanced and/or metastatic cancer (including Non-Hodgkin's Lymphoma) for whom no treatment of higher priority exists.
- Conditions
- Advanced Cancer, Metastatic Cancer
- Being tested
- LY2523355, pegfilgrastim
- Keywords
- Advanced Cancer, Metastatic Cancer, 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.
LY2523355Drug
Administered intravenously as a 1-hour infusion on Days 1, 2, 3 of each 21-day cycle for at least 2 cycles. Participants may continue on study drug until disease progression, unacceptable toxicity or other withdrawal criterion is met. Starting dose for LY2523355 alone arm is 0.125 milligrams per meter square per day (mg/m²/day).
LY2523355Drug
Administered intravenously as a 1-hour infusion on Days 1, 2, 3 of each 21-day cycle for at least 2 cycles. Participants may continue on study drug until disease progression, unacceptable toxicity or other withdrawal criterion is met. Starting dose for LY2523355 + pegfilgrastim is 4 mg/m²/day.
pegfilgrastimDrug
6 milligrams (mg) administered subcutaneously on Day 4 of each 21-day cycle for the 2 planned cycles and for any subsequent cycles of LY2523355 received.
| Study group | Role | What they receive |
|---|---|---|
| LY2523355 | Experimental | Not described Receives: Drug: LY2523355 |
| LY2523355 + pegfilgrastim | Experimental | Not described Receives: Drug: LY2523355; Drug: pegfilgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Dose for Phase 2 Studies
Recommended Phase 2 dose was determined by the maximum tolerated dose (MTD). The MTD was defined as the dose that caused <1/3 of all participants treated with the study drug to experience a dose-limiting toxicity (DLT). A DLT was defined as an adverse event (AE) occurring during Cycle 1 that fulfilled 1 of the following criteria: Any Common Terminology Criteria for Adverse Events (CTCAE), version (v) 3.0 Grade ≥3 nonhematological toxicity possibly or likely related to the study drug (except for nausea/vomiting/diarrhea without maximal symptomatic/prophylactic treatment); any CTCAE v 3.0 Grade ≥3 thrombocytopenia with bleeding; any CTCAE v3.0 Grade 4 hematological toxicity of >5 days duration; any febrile neutropenia.
Measured: Baseline, daily up to 21 days in Cycle 1
Secondary outcomes (6)
Number of Participants With Clinically Significant Effects
Adverse events (AEs) were considered clinically significant effects. Data presented are the number of participants who experienced serious AEs (SAEs), other non-serious AEs and deaths during the study, including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Measured: Baseline to study completion including 30-day follow-up up to 647 days,any AE reported
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2523355 Following A Single Dose
Cmax following a single dose of LY2523355 at each dose level in the presence or absence of pegfilgrastim.
Measured: Cycle 1 Day 1(21-day cycle):End of infusion (EOI), Day 2: Predose, EOI, Day 3: Predose, EOI, between 1-2 hour EOI, Day 4: anytime, Day 8:anytime, Day 9: anytime, Day 10: anytime
Pharmacokinetics: Plasma Cmax of LY2523355 Following Multiple Doses
Cmax following multiple doses of LY2523355 at each dose level in the presence or absence of pegfilgrastim.
Measured: Cycle 1, Day 3(21-day cycle): End of infusion
Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY2523355 Following A Single Dose
AUC(0-∞) following a single dose of LY2523355 at each dose level in the presence or absence of pegfilgrastim.
Measured: Cycle 1,Day 1(21-day cycle): End of infusion (EOI), Day 2: Predose, EOI, Day 3: Predose, EOI, between 1-2 hour EOI, Day 4: anytime, Day 8:anytime, Day 9: anytime, Day 10: anytime
Pharmacokinetics: AUC(0-∞) of LY2523355 Following Multiple Doses
AUC(0-∞) following multiple doses of LY2523355 at each dose level in the presence or absence of pegfilgrastim.
Measured: Cycle 1, Day 3(21-day cycle): End of infusion
Number of Participants With Tumor Response
Data presented are the number of participants with a confirmed complete response (CR) or partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is the disappearance of all target and non-target lesions. PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions.
Measured: Baseline to measured disease progression or discontinuation up to 617 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startJul 2007
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
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 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214629
- Sponsor's protocol ID
- 11618
- Other IDs
- I1Y-MC-JFBA
- Status last verified
- Aug 2018
- First submitted
- 1 Oct 2010
- Last updated
- 6 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of LY2523355 in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT01214629
- Acronym / sponsor ID
- 11618
- Conditions
- Advanced Cancer, Metastatic Cancer
- Keywords
- Advanced Cancer, Metastatic Cancer, Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 5 Oct 2010 (estimated)
- Results
- Posted 6 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to determine the safety of LY2523355 for the treatment of advanced and/or metastatic cancer (including Non-Hodgkin's lymphoma).
Detailed description
This study is a multi-center, non-randomized, open label, dose-escalation, Phase 1 study of intravenous LY2523355 in participants with advanced and/or metastatic cancer (including Non-Hodgkin's Lymphoma) for whom no treatment of higher priority exists.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY2523355 | Experimental | Drug: LY2523355 |
| LY2523355 + pegfilgrastim | Experimental | Drug: LY2523355, Drug: pegfilgrastim |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have a diagnosis of advanced and/or metastatic cancer (solid tumors or Non-Hodgkin's lymphoma) that is refractory to standard therapy or for which no proven effective therapy exists. Participants entering Part B of the study must also have a tumor that is safely amenable to serial biopsies
- Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST, Therasse et al. 2000) or Revised International Working Group Lymphoma Response Criteria (Cheson et al. 2007)
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
- Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 28 days (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment
- 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 (6 listed)
- Have symptomatic, untreated or uncontrolled central nervous system (CNS) metastases. Participants 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 participants without history of CNS metastases is not required
- Have current acute or chronic leukemia
- Have had an autologous or allogenic bone marrow transplant
- Have the following conduction abnormalities: PR >250 milliseconds (msec), second degree or complete atrioventricular (AV) block, intraventricular conduction delay (IVCD) with QRS ≥120 msec, left branch bundle block (LBBB), right branch bundle block (RBBB), Wolf-Parkinson- White syndrome (WPW), left anterior fascicular block (LAFB), left posterior fascicular block (LPFB), or other conduction abnormality that in the opinion of the investigator would preclude safe participation in this study.
- Females who are pregnant or lactating
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 |
|---|---|---|
| LY2523355Administered intravenously as a 1-hour infusion on Days 1, 2, 3 of each 21-day cycle for at least 2 cycles. Participants may continue on study drug until disease progression, unacceptable toxicity or other withdrawal criterion is met. Starting dose for LY2523355 alone arm is 0.125 milligrams per meter square per day (mg/m²/day). | Drug | LY2523355 |
| LY2523355Administered intravenously as a 1-hour infusion on Days 1, 2, 3 of each 21-day cycle for at least 2 cycles. Participants may continue on study drug until disease progression, unacceptable toxicity or other withdrawal criterion is met. Starting dose for LY2523355 + pegfilgrastim is 4 mg/m²/day. | Drug | LY2523355 + pegfilgrastim |
| pegfilgrastim6 milligrams (mg) administered subcutaneously on Day 4 of each 21-day cycle for the 2 planned cycles and for any subsequent cycles of LY2523355 received. | Drug | LY2523355 + pegfilgrastim |
Primary outcome
Recommended Dose for Phase 2 Studies
Time frame: Baseline, daily up to 21 days in Cycle 1
Recommended Phase 2 dose was determined by the maximum tolerated dose (MTD). The MTD was defined as the dose that caused <1/3 of all participants treated with the study drug to experience a dose-limiting toxicity (DLT). A DLT was defined as an adverse event (AE) occurring during Cycle 1 that fulfilled 1 of the following criteria: Any Common Terminology Criteria for Adverse Events (CTCAE), version (v) 3.0 Grade ≥3 nonhematological toxicity possibly or likely related to the study drug (except for nausea/vomiting/diarrhea without maximal symptomatic/prophylactic treatment); any CTCAE v 3.0 Grade ≥3 thrombocytopenia with bleeding; any CTCAE v3.0 Grade 4 hematological toxicity of >5 days duration; any febrile neutropenia.
6 secondary outcomes
Number of Participants With Clinically Significant Effects
Time frame: Baseline to study completion including 30-day follow-up up to 647 days,any AE reported
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2523355 Following A Single Dose
Time frame: Cycle 1 Day 1(21-day cycle):End of infusion (EOI), Day 2: Predose, EOI, Day 3: Predose, EOI, between 1-2 hour EOI, Day 4: anytime, Day 8:anytime, Day 9: anytime, Day 10: anytime
Pharmacokinetics: Plasma Cmax of LY2523355 Following Multiple Doses
Time frame: Cycle 1, Day 3(21-day cycle): End of infusion
Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY2523355 Following A Single Dose
Time frame: Cycle 1,Day 1(21-day cycle): End of infusion (EOI), Day 2: Predose, EOI, Day 3: Predose, EOI, between 1-2 hour EOI, Day 4: anytime, Day 8:anytime, Day 9: anytime, Day 10: anytime
Pharmacokinetics: AUC(0-∞) of LY2523355 Following Multiple Doses
Time frame: Cycle 1, Day 3(21-day cycle): End of infusion
Number of Participants With Tumor Response
Time frame: Baseline to measured disease progression or discontinuation up to 617 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 hours, 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 LY2523355 and pegfilgrastim in people with Advanced Cancer and 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 7 inclusion and 6 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 6 Aug 2018. 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?
Yes. Results are posted in the registry (first posted 6 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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, daily up to 21 days in Cycle 1). 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 6 Aug 2018.