NeoplasmsPhase 1NCT01722825
Study of LY2157299 in Japanese Participants With Cancer
A Phase 1 study testing LY2157299 in people with Neoplasms and Neoplasm Metastasis, run by Eli Lilly and Company at 1 site in Japan.
Trial summary
The main purpose of this study is to evaluate the safety and side effects of LY2157299 in Japanese participants with advanced cancer or cancer that has spread to other parts of the body. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Neoplasms, Neoplasm Metastasis
- What is being tested?
- LY2157299
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2012to Jun 2014
- 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 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 cancer that is advanced and/or metastatic. The participants must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed to provide clinical benefit for their disease.
- Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors.
- Have a performance status of higher than or equal to 1 on the Eastern Cooperative Oncology Group scale.
- Have adequate hematologic, hepatic and renal function.
- Have discontinued treatments for cancer excluding palliative treatments and recovered from the acute effects of therapy.
- Have discontinued treatment at least 28 days prior to the enrollment for an experimental agent that has not received regulatory approval for any indication.
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- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
- Able to swallow tablets.
- Have an estimated life expectancy, in the judgment of the investigator, that will permit the participant to complete greater than or equal to 2 cycles of treatment.
- Males and females with reproductive potential: Must agree to use medically approved contraceptive precautions during the study and for 4 months following the last dose of study drug.
- Females with child bearing potential: Have had a negative urine/serum pregnancy test greater than or equal to 7 days before the first dose of study drug and must also not be breastfeeding. If female who stops breastfeeding enters the study, the female must stop breastfeeding from the day of the first study drug administration until at least 30 days after the last administration.
Who cannot join
- Have moderate or severe cardiac disease:
- Have the presence of cardiac disease, including a myocardial infarction within 6 months prior to study entry, angina pectoris, New York Heart Association Class III/IV congestive heart failure, or uncontrolled severe hypertension.
- Have documented major electrocardiogram abnormalities at the investigator's discretion.
- Have major abnormalities documented by echocardiography with Doppler. Clinically non-significant abnormalities are excluded from this criterion.
- Have persistently elevated brain natriuretic peptide or elevated Troponin I at screening local laboratory tests.
- Have predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress.
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- Have a history of cardiac or aortic surgery.
- Have current hematological malignancies.
- Have central nervous system metastases.
- Have serious preexisting medical conditions as follows;
- Presence or history of interstitial pneumonitis
- Uncontrollable severe diabetes
- Presence of serious active infection or uncontrollable chronic infection
- Presence of liver cirrhosis with Child-Pugh Stage of B or C
- Other serious conditions judged by the investigator
- Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibodies (HC Ab). Testing is not required unless circumstances warrant confirmation.
- In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study.
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.
Tokyo, 104-0045
About this study
Official title: Phase 1 Dose-Escalation Study of LY2157299 Monotherapy in Patients With Solid Tumors
The main purpose of this study is to evaluate the safety and side effects of LY2157299 in Japanese participants with advanced cancer or cancer that has spread to other parts of the body.
- Conditions
- Neoplasms, Neoplasm Metastasis
- Being tested
- LY2157299
- 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.
LY2157299Drug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| LY2157299 | Experimental | 80 up to 150 milligrams of LY2157299 administered orally, twice daily for 14 days, followed by 14 days with no study drug (2 weeks on/2 weeks off schedule) for at least two 28 day cycles. Participants receiving clinical benefit may continue receiving treatment until discontinuation criterion is met. Receives: Drug: LY2157299 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose-Limiting Toxicities
Measured: Day 1 through Day 28 of Cycle 1
Secondary outcomes (3)
Pharmacokinetics: Maximum Concentration (Cmax) of LY2157299
Measured: Days 1, 3, 6 and 14 of Cycle 1 and Days 1 and 14 of Cycle 2
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of LY2157299
Measured: Predose up to 6 hours postdose on Days 1 and 14 of Cycles 1 and 2
Number of Participants with a Tumor Response
Measured: Baseline to study completion estimated at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies 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
- 12 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 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722825
- Sponsor's protocol ID
- 14854
- Other IDs
- H9H-JE-JBAN
- Status last verified
- Jun 2014
- First submitted
- 5 Nov 2012
- Last updated
- 1 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Fujiwara Y, Nokihara H, Yamada Y, Yamamoto N, Sunami K, Utsumi H, Asou H, TakahashI O, Ogasawara K, Gueorguieva I, Tamura T. Phase 1 study of galunisertib, a TGF-beta receptor I kinase inhibitor, in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2015 Dec;76(6):1143-52. doi: 10.1007/s00280-015-2895-4. Epub 2015 Nov 3.
PubMed 26526984
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Dose-Escalation Study of LY2157299 Monotherapy in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT01722825
- Acronym / sponsor ID
- 14854
- Conditions
- Neoplasms, Neoplasm Metastasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 7 Nov 2012 (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 evaluate the safety and side effects of LY2157299 in Japanese participants with advanced cancer or cancer that has spread to other parts of the body.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LY2157299 | Experimental | Drug: LY215729980 up to 150 milligrams of LY2157299 administered orally, twice daily for 14 days, followed by 14 days with no study drug (2 weeks on/2 weeks off schedule) for at least two 28 day cycles. Participants receiving clinical benefit may continue receiving treatment until discontinuation criterion is met. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic. The participants must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed to provide clinical benefit for their disease.
- Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors.
- Have a performance status of higher than or equal to 1 on the Eastern Cooperative Oncology Group scale.
- Have adequate hematologic, hepatic and renal function.
- Have discontinued treatments for cancer excluding palliative treatments and recovered from the acute effects of therapy.
Key exclusion criteria (17 listed)
- Have moderate or severe cardiac disease:
- Have current hematological malignancies.
- Have central nervous system metastases.
- Have serious preexisting medical conditions as follows;
- Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibodies (HC Ab). Testing is not required unless circumstances warrant confirmation.
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 |
|---|---|---|
| LY2157299Administered orally. | Drug | LY2157299 |
Primary outcome
Number of Participants with Dose-Limiting Toxicities
Time frame: Day 1 through Day 28 of Cycle 1
3 secondary outcomes
Pharmacokinetics: Maximum Concentration (Cmax) of LY2157299
Time frame: Days 1, 3, 6 and 14 of Cycle 1 and Days 1 and 14 of Cycle 2
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of LY2157299
Time frame: Predose up to 6 hours postdose on Days 1 and 14 of Cycles 1 and 2
Number of Participants with a Tumor Response
Time frame: Baseline to study completion estimated at 16 weeks
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 1 Jul 2014.
- Derived from this study: PubMed 26526984Fujiwara Y, Nokihara H, Yamada Y, Yamamoto N, Sunami K, Utsumi H, Asou H, TakahashI O, Ogasawara K, Gueorguieva I, Tamura T. Phase 1 study of galunisertib, a TGF-beta receptor I kinase inhibitor, in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2015 Dec;76(6):1143-52. doi: 10.1007/s00280-015-2895-4. Epub 2015 Nov 3.
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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 9AM - 5PM 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 LY2157299 in people with Neoplasms and Neoplasm Metastasis, 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 11 inclusion and 17 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 1 Jul 2014. 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?
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?
Number of Participants with Dose-Limiting Toxicities (time frame: Day 1 through Day 28 of Cycle 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01722825, which also lists 1 linked publication.
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 1 Jul 2014.