CancerPhase 1NCT01241461
A Study of LY2584702 in Solid Tumors
A Phase 1 study testing LY2584702 in people with Cancer, run by Eli Lilly and Company at 1 site in Japan.
Trial summary
The purpose of this study is to assess the safety and tolerability of LY2584702 in Japanese patients with advanced and/or metastatic solid tumors for which no proven effective therapy exists. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- LY2584702
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2010to Nov 2011
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have histological or cytological evidence of a diagnosis of advanced and/or metastatic cancer (solid tumors) that is refractory to standard therapy and/or therapies known to provide clinical benefit, or for which no standard therapy exists.
- Have the presence of disease amenable to efficacy assessment as defined by the Response Evaluation Criteria In Solid Tumors (RECIST). Japanese patients who have advanced non-measurable disease with elevation of a validated tumor marker may be eligible, if discussed and agreed upon by the investigator and Lilly.
- Have adequate organ function including:
- Hematologic: Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/liter (L), platelets greater than or equal to 100 x 10^9/L, and hemoglobin greater than or equal to 9 gram/deciliter (g/dL) (transfusions are not allowed prior to enrollment within 2 weeks).
- Hepatic: Bilirubin less than or equal to 1.5 times upper limit of normal (ULN), alkaline phosphatase (ALP), alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN, or 5 times ULN for patients with hepatic metastases. Patients with bone metastases may enter with alkaline phosphatase values less than 5 times ULN, as long as other hepatic parameters meet inclusion criteria.
- Renal: Serum creatinine less than or equal to 1.5 times ULN.
Show all 10Show fewer
- Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group scale
- Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy prior to study enrollment and recovered from the acute effects of therapy.
- Have an estimated life expectancy of 12 weeks or greater
- Are able to swallow capsules
Who cannot join
- Have received treatment within 4 weeks of the initial dose of study drug with a drug that has not received regulatory approval for any indication.
- Have serious preexisting medical conditions or serious concomitant systemic disorders that, in the opinion of the investigator, would preclude participation in this study.
- Prior clinical history of tuberculosis (patient doubt tuberculosis is screening required), and positive test results in hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb) (screening required).
- Have symptomatic central nervous system (CNS) 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 metastasis is not required.
- Have hematologic malignancies, or lymphoma.
Trial locations and contacts
1 site in 1 country.
Japan1 site
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.
Chiba
About this study
Official title: A Phase 1 Study of LY2584702 in Japanese Patients With Solid Tumors
The purpose of this study is to assess the safety and tolerability of LY2584702 in Japanese patients with advanced and/or metastatic solid tumors for which no proven effective therapy exists.
- Conditions
- Cancer
- Being tested
- LY2584702
- Keywords
- Advanced Cancer, Metastatic Cancer, p70s6 inhibitor
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2584702Drug
Dose escalation starting at 50 milligram (mg). On Day 1, subjects will receive a single oral dose. After a two-day observation period, subjects will receive oral doses twice daily for a 28-day cycle.
Patients may continue 28-day cycles of twice daily dosing until discontinuation criteria are met.
| Study group | Role | What they receive |
|---|---|---|
| LY2584702 | Experimental | Not described Receives: Drug: LY2584702 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinically Significant Effects
A clinically significant effect was any event that was a dose-limiting toxicity event (DLT). DLT was defined as an adverse event related to LY2584702 during Cycle 1 (Day 1 to Day 30) that fulfills any one of the following criteria; Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 non-hematological toxicity; platelet count <50.0 x 10^9/Liter (L) with bleeding; CTCAE Grade 4 platelet count decreased; neutrophil count <0.5 x 10^9/L lasting for 5 days or longer; any febrile neutropenia; CTCAE Grade 4 anemia; participant risk due to increasing toxicity.
Measured: Baseline through 30 days
Secondary outcomes (3)
Number of Participants With Tumor Response
Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1. Complete Response (CR) is disappearance of all target lesions; Partial Response (PR) is ≥30% decrease in sum of longest diameter of target lesions.
Measured: Baseline to study completion up to Day 183
Pharmacokinetics: Area Under the Concentration Time Curve (AUC) of LY2584702
AUC of single dose is AUC(0-12hours), and AUC of multiple doses is AUC during one dosing interval at steady state.
Measured: Cycle 1 Day 1: Predose, 0.5,1,2,3,5,8,12 hours; Cycle 1 Day 2:24 and 36 hours; Cycle 1 Day 3: Predose sample (before first dose on day 3); Cycle 1 Day 10: Predose,0.5,1,2,3,5,8,12 hours;Cycle 1 Day 17: Predose;Cycle 1 Day24: Predose;Cycle 2 Day 1: Predose
Pharmacokinetics: Maximum Concentration (Cmax) of LY2584702
Measured: Cycle 1 Day 1: Predose, 0.5,1,2,3,5,8,12 hours; Cycle 1 Day 2:24 and 36 hours; Cycle 1 Day 3: Predose sample (before first dose on day 3); Cycle 1 Day 10: Predose,0.5,1,2,3,5,8,12 hours;Cycle 1 Day 17: Predose;Cycle 1 Day24: Predose;Cycle 2 Day 1: Predose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startNov 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.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 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
- NCT01241461
- Sponsor's protocol ID
- 13871
- Other IDs
- I3G-JE-JGCC
- Status last verified
- Jul 2018
- First submitted
- 12 Nov 2010
- Last updated
- 21 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of LY2584702 in Japanese Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT01241461
- Acronym / sponsor ID
- 13871
- Conditions
- Cancer
- Keywords
- Advanced Cancer, Metastatic Cancer, p70s6 inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 16 Nov 2010 (estimated)
- Results
- Posted 16 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and tolerability of LY2584702 in Japanese patients with advanced and/or metastatic solid tumors for which no proven effective therapy exists.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LY2584702 | Experimental | Drug: LY2584702 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have histological or cytological evidence of a diagnosis of advanced and/or metastatic cancer (solid tumors) that is refractory to standard therapy and/or therapies known to provide clinical benefit, or for which no standard therapy exists.
- Have the presence of disease amenable to efficacy assessment as defined by the Response Evaluation Criteria In Solid Tumors (RECIST). Japanese patients who have advanced non-measurable disease with elevation of a validated tumor marker may be eligible, if discussed and agreed upon by the investigator and Lilly.
- Have adequate organ function including:
- Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group scale
- Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy prior to study enrollment and recovered from the acute effects of therapy.
Key exclusion criteria (5 listed)
- Have received treatment within 4 weeks of the initial dose of study drug with a drug that has not received regulatory approval for any indication.
- Have serious preexisting medical conditions or serious concomitant systemic disorders that, in the opinion of the investigator, would preclude participation in this study.
- Prior clinical history of tuberculosis (patient doubt tuberculosis is screening required), and positive test results in hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb) (screening required).
- Have symptomatic central nervous system (CNS) 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 metastasis is not required.
- Have hematologic malignancies, or lymphoma.
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 |
|---|---|---|
| LY2584702Dose escalation starting at 50 milligram (mg). On Day 1, subjects will receive a single oral dose. After a two-day observation period, subjects will receive oral doses twice daily for a 28-day cycle. Patients may continue 28-day cycles of twice daily dosing until discontinuation criteria are met. | Drug | LY2584702 |
Primary outcome
Number of Participants With Clinically Significant Effects
Time frame: Baseline through 30 days
A clinically significant effect was any event that was a dose-limiting toxicity event (DLT). DLT was defined as an adverse event related to LY2584702 during Cycle 1 (Day 1 to Day 30) that fulfills any one of the following criteria; Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 non-hematological toxicity; platelet count <50.0 x 10^9/Liter (L) with bleeding; CTCAE Grade 4 platelet count decreased; neutrophil count <0.5 x 10^9/L lasting for 5 days or longer; any febrile neutropenia; CTCAE Grade 4 anemia; participant risk due to increasing toxicity.
3 secondary outcomes
Number of Participants With Tumor Response
Time frame: Baseline to study completion up to Day 183
Pharmacokinetics: Area Under the Concentration Time Curve (AUC) of LY2584702
Time frame: Cycle 1 Day 1: Predose, 0.5,1,2,3,5,8,12 hours; Cycle 1 Day 2:24 and 36 hours; Cycle 1 Day 3: Predose sample (before first dose on day 3); Cycle 1 Day 10: Predose,0.5,1,2,3,5,8,12 hours;Cycle 1 Day 17: Predose;Cycle 1 Day24: Predose;Cycle 2 Day 1: Predose
Pharmacokinetics: Maximum Concentration (Cmax) of LY2584702
Time frame: Cycle 1 Day 1: Predose, 0.5,1,2,3,5,8,12 hours; Cycle 1 Day 2:24 and 36 hours; Cycle 1 Day 3: Predose sample (before first dose on day 3); Cycle 1 Day 10: Predose,0.5,1,2,3,5,8,12 hours;Cycle 1 Day 17: Predose;Cycle 1 Day24: Predose;Cycle 2 Day 1: Predose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY2584702 in people with Cancer, run by Eli Lilly and Company at 1 site in Japan.
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 10 inclusion and 5 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 21 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 1 site in Japan. 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 16 Jul 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?
Number of Participants With Clinically Significant Effects (time frame: Baseline through 30 days). 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 21 Aug 2018.