NeoplasmPhase 1NCT02304419
A Study of Galunisertib on the Immune System in Participants With Cancer
A Phase 1 study testing Galunisertib in people with Neoplasm, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The main purpose of this study is to learn more about how the study drug called galunisertib affects the immune system in participants with cancer. The study treatment is expected to last about six months for each participant, not including screening or follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm
- What is being tested?
- Galunisertib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Aug 2016
- 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
- Have a confirmed diagnosis of advanced, refractory solid tumors and tumor progression or treatment intolerance to at least 1 prior therapy.
- Have measurable disease that is amenable to a radiographic or ultrasound-guided biopsy or may be biopsied in the office without radiologic guidance.
- Have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale.
- Have discontinued all disease-modifying therapy for the primary cancer for 28 days prior to initiation of study treatment.
- Hepatic: bilirubin ≤1.5 times upper limits of normal (ULN), alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤3.0 times ULN. For participants with tumor involvement of the liver, AST and ALT equaling
- ≤5.0 times ULN are acceptable. Alkaline phosphatase ≤5.0 times ULN for participants with tumor involvement of the bone is acceptable.
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- Have adequate renal function, defined as serum creatinine levels ≤2.0 ULN or calculated creatinine clearance >45 mL/min.
- Male and female participants with reproductive potential must use an approved contraceptive method, if appropriate (for example, intrauterine device, birth control pills, or barrier device) during and for 6 months after discontinuation of study treatment.
- Women of childbearing potential must have a negative beta-human chorionic gonadotropin pregnancy test documented within 7 days prior to treatment. Have given written informed consent prior to any study-specific procedures.
- Are willing and able to comply with study procedures and instructions, including completion of diaries.
- Must have received at least 1 prior approved immunotherapy or chemotherapy; however, not within 28 days of the initial dose of study drug. May have received prior radiotherapy for their malignancy.
- May have received treatment with an investigational product.
Who cannot join
- Are enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study within 28 days of the initial dose of study drug.
- Have moderate or severe cardiac disease:
- Have the presence of cardiac disease, including a myocardial infarction within 6 months prior to study entry, unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, or uncontrolled hypertension.
- Have documented major electrocardiogram (ECG) abnormalities (not responding to medical treatments) at the investigator's discretion (for example, symptomatic or sustained atrial or ventricular arrhythmias, second- or third-degree atrioventricular block, complete bundle branch block, ventricular hypertrophy, or recent myocardial infarction).
- Have major abnormalities documented by echocardiography (ECHO) with Doppler (for example, moderate or severe heart valve function defect and/or left ventricular ejection fraction <50%, evaluation based on the institutional lower limit of normal).
- Have predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress (for example, family history of aneurysms, Marfan-Syndrome, bicuspid aortic valve, evidence of damage to the large vessels of the heart documented by computed tomography (CT) scan with contrast).
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- Are women who are pregnant or lactating.
- Have a serious concomitant systemic disorder (for example, active infection including human immunodeficiency virus [HIV], hepatitis C virus [HCV], hepatitis B virus [HBV] [ie, positive hepatitis B surface antigen [+HBsAg]]), or an autoimmune disease.
- Have a second primary malignancy or any history in any time frame of a prior malignancy.
- Are unwilling or unable to participate in, or do not have tissue adequate for participation in the biomarker analyses in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Phase 1 Study to Determine the Immunomodulatory Activity of LY2157299 Monohydrate in Patients With Solid Tumors
The main purpose of this study is to learn more about how the study drug called galunisertib affects the immune system in participants with cancer. The study treatment is expected to last about six months for each participant, not including screening or follow-up.
- Conditions
- Neoplasm
- Being tested
- Galunisertib
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GalunisertibDrug
Also called LY2157299
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Galunisertib | Experimental | 150 milligrams galunisertib given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Treatment is expected to last for 6 cycles. Participants may receive additional cycles if they are deriving clinical benefit. Receives: Drug: Galunisertib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Immune Cell Subsets
Measured: Baseline up to Cycle 6 (Cycle = 28 Days)
Change from Baseline in Serum Cytokines
Measured: Baseline up to Cycle 6 (Cycle = 28 Days)
Change from Baseline in Humoral Immunity
Measured: Baseline up to Cycle 6 (Cycle = 28 Days)
Secondary outcomes (1)
Pharmacokinetics: Area Under the Concentration Time Curve of Galunisertib
Measured: Cycles 1 and 2: Predose on Day 1, Day 14 and Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startMay 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT02304419
- Sponsor's protocol ID
- 15189
- Other IDs
- H9H-MC-JBAT
- Status last verified
- Oct 2016
- First submitted
- 26 Nov 2014
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Determine the Immunomodulatory Activity of LY2157299 Monohydrate in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT02304419
- Acronym / sponsor ID
- 15189
- Conditions
- Neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 2 Dec 2014 (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.
The main purpose of this study is to learn more about how the study drug called galunisertib affects the immune system in participants with cancer. The study treatment is expected to last about six months for each participant, not including screening or follow-up.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Galunisertib | Experimental | Drug: Galunisertib150 milligrams galunisertib given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Treatment is expected to last for 6 cycles. Participants may receive additional cycles if they are deriving clinical benefit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Have a confirmed diagnosis of advanced, refractory solid tumors and tumor progression or treatment intolerance to at least 1 prior therapy.
- Have measurable disease that is amenable to a radiographic or ultrasound-guided biopsy or may be biopsied in the office without radiologic guidance.
- Have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale.
- Have discontinued all disease-modifying therapy for the primary cancer for 28 days prior to initiation of study treatment.
- Hepatic: bilirubin ≤1.5 times upper limits of normal (ULN), alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤3.0 times ULN. For participants with tumor involvement of the liver, AST and ALT equaling
Key exclusion criteria (10 listed)
- Are enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study within 28 days of the initial dose of study drug.
- Have moderate or severe cardiac disease:
- Are women who are pregnant or lactating.
- Have a serious concomitant systemic disorder (for example, active infection including human immunodeficiency virus [HIV], hepatitis C virus [HCV], hepatitis B virus [HBV] [ie, positive hepatitis B surface antigen [+HBsAg]]), or an autoimmune disease.
- Have a second primary malignancy or any history in any time frame of a prior malignancy.
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 |
|---|---|---|
| GalunisertibAlso: LY2157299Administered orally. | Drug | Galunisertib |
Primary outcome
Change from Baseline in Immune Cell Subsets
Time frame: Baseline up to Cycle 6 (Cycle = 28 Days)
Change from Baseline in Serum Cytokines
Time frame: Baseline up to Cycle 6 (Cycle = 28 Days)
Change from Baseline in Humoral Immunity
Time frame: Baseline up to Cycle 6 (Cycle = 28 Days)
1 secondary outcome
Pharmacokinetics: Area Under the Concentration Time Curve of Galunisertib
Time frame: Cycles 1 and 2: Predose on Day 1, Day 14 and Day 15
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 5 Oct 2016.
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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 Galunisertib in people with Neoplasm, run by Eli Lilly and Company at 1 site 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 12 inclusion and 10 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 5 Oct 2016. 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 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?
Change from Baseline in Immune Cell Subsets (time frame: Baseline up to Cycle 6 (Cycle = 28 Days)). The study lists 3 primary outcomes in all. 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 5 Oct 2016.