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Solid TumorsPhase 1NCT01602289

A Study of LY2875358 in Japanese Participants With Advanced Cancer

A Phase 1 study testing LY2875358, Erlotinib and Gefitinib in people with Solid Tumors and Lymphoma, run by Eli Lilly and Company at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the safety and tolerability of LY2875358 in Japanese participants with cancer that is advanced and/or may have spread to another part of the body. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
LY2875358, Erlotinib and Gefitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteJapan
Study dates
Jun 2012to Aug 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

  • Part A: Have histological or cytological evidence of malignancies (solid tumor or lymphoma) that are advanced and/or metastatic. The participant must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have been used
  • Part B1: Have histologic or cytologic diagnosis of advanced NSCLC, Stage IV per the 7th edition of the American Joint Committee on Cancer (AJCC) Staging Criteria for NSCLC. The participants must have no other effective therapeutic option and be eligible for erlotinib therapy per Japanese package insert in the opinion of investigator
  • Part B2: Have histologic or cytologic diagnosis of advanced NSCLC with epidermal growth factor receptor (EGFR) activating mutation, Stage IV per the 7th edition of the AJCC Staging Criteria for NSCLC. The participants must have no other effective therapeutic option and be eligible for gefitinib therapy per Japanese package insert in the opinion of investigator
  • Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Revised Response Criteria for Malignant Lymphoma
  • Have adequate hematologic, hepatic and renal function
  • Have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale
Show all 10Show fewer
  • Have discontinued all previous cancer therapies, and any agents that have not received regulatory approval for any indication, for at least 21 days or 5 half lives prior to study enrollment, whichever is shorter, and recovered from the acute effects of therapy (treatment-related toxicity resolved to baseline or ≤ Grade 1). Participants must have discontinued mitomycin-C or nitrosourea therapy for at least 42 days
  • 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 or until in the judgment of the investigator, it is safe for the participant to become pregnant
  • Females with child bearing potential: Have had a negative urine pregnancy test ≤7 days before the first dose of study drug and must also not be breastfeeding. If female who stop breastfeeding enter the study, the female must stop breastfeeding from the day of the first study drug administration until 4 months after the last dose
  • Have an estimated life expectancy, in the judgment of the investigator, that will permit the participant to complete 8 weeks of treatment

Who cannot join

  • Have serious preexisting medical conditions
  • Part A: Have symptomatic central nervous system malignancy or metastasis
  • Part B: Have brain metastases that are symptomatic or require ongoing treatment with steroids or radiation therapy
  • Have current acute or chronic leukemia (participants with adult T-cell leukemia/lymphoma are eligible)
  • Have an active fungal, bacterial, and/or known viral infection
  • Have a second primary malignancy that in the judgment of the investigator and sponsor may affect the interpretation of results
Show all 17Show fewer
  • Have a history of New York Heart Association (NYHA) class ≥3, unstable angina, myocardial infarction in 6 months prior to study drug administration
  • Have QTc interval of >470 milliseconds (msec) on screening electrocardiogram
  • Have received a liver transplant, or have liver cirrhosis with a Child-Pugh Stage of B or C
  • Participants with active alcohol abuse, as determined by the treating investigator
  • Previous treatment with any extracellular domain of mesenchymal-epithelial transition factor (c-MET) targeting experimental therapeutic (for example, XL184, ARQ197, or onartuzumab)
  • Have a history of radiation therapy involving more than 25% of the bone marrow. Previous radiation therapy is allowed but should have been limited and must not have included whole pelvis radiation
  • Part B: The participants actively receiving warfarin therapy at the time of enrollment
  • Part B: Concomitant treatment with the cytochrome P450 (CYP) 3A4 modulators. The participants must not have received treatment with any of these modulators within 14 days of Cycle 1 Day 1
  • Part B: Have any evidence of clinically active interstitial lung disease (ILD). Asymptomatic participants with chronic, stable, radiographic changes are eligible
  • Part B: Have preexisting interstitial lung disease risks as evidenced by computed tomography (CT) scan/X-ray at baseline; have or had any disease of acute lung injury, idiopathic pulmonary fibrosis, pneumonitis, or pneumoconiosis evident on an x-ray; have or had any disease of radiation pneumonia or drug-induced pneumonia, which requires treatment with corticosteroids
  • Part B: Have previously been intolerant of therapy with erlotinib or gefitinib

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, 277-8577

Other trials in Japan

About this study

Official title: A Phase 1 Study of LY2875358 in Japanese Patients With Advanced Malignancies

The purpose of this study is to assess the safety and tolerability of LY2875358 in Japanese participants with cancer that is advanced and/or may have spread to another part of the body.

Read the detailed description

This study has 3 parts. Participants may only enroll in one part.

Part A - Participants will receive LY2875358.

Part B1 - Participants with non-small cell lung cancer (NSCLC) will receive LY2875358 and erlotinib.

Part B2 - Participants with NSCLC will receive LY2875358 and gefitinib.

Parts B1 and B2 were added per protocol amendment in January, 2013.

Being tested
LY2875358, Erlotinib, Gefitinib
Medical subject headings
Lymphoma, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY2875358Biological

    Administered IV

  • ErlotinibDrug

    Administered orally

  • GefitinibDrug

    Administered orally

Study groups in NCT01602289
Study groupRoleWhat they receive
LY2875358ExperimentalPart A. LY2875358 will be administered intravenously (IV) at escalating doses (700 mg up to 2000 mg) on Day 1 and Day 15 of a 28-day cycle, until any discontinuation criterion is met.
Receives: Biological: LY2875358
LY2875358+ErlotinibExperimentalPart B1. Erlotinib will be administered orally at 150 mg dose level each day. LY2875358 will be administered intravenously (IV) at recommended dose level in Part A on Day 1 and Day 15 of a 28-day cycle. (Part B1 was added per protocol amendment in January, 2013.)
Receives: Drug: Erlotinib
LY2875358+GefitinibExperimentalPart B2. Gefitinib will be administered orally at 250 mg dose level each day. LY2875358 will be administered intravenously (IV) at recommended dose level in Part A on Day 1 and Day 15 of a 28-day cycle. (Part B2 was added per protocol amendment in January, 2013.)
Receives: Drug: Gefitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with one or more drug (or procedure)-related adverse events (AEs) or any serious AEs

    Measured: Baseline up to 56 days after last dose of study drug

Secondary outcomes (3)

  1. Pharmacokinetics (PK): Maximum concentration (Cmax) of LY2875358, erlotinib and gefitinib

    Measured: Predose up to Cycle 6

  2. Pharmacokinetics (PK): Area under the concentration time curve (AUC) of LY2875358, erlotinib and gefitinib

    Measured: Predose up to Cycle 6

  3. Number of participants with a tumor response

    Measured: Baseline to study completion (estimated to be 5 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionAug 2014
  4. Study completionAug 2014

Resources

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
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01602289
Sponsor's protocol ID
14637
Other IDs
I4C-JE-JTBD
Status last verified
Jun 2015
First submitted
15 May 2012
Last updated
8 Jun 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY2875358, Erlotinib and Gefitinib in people with Solid Tumors and Lymphoma, 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 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 8 Jun 2015. 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 one or more drug (or procedure)-related adverse events (AEs) or any serious AEs (time frame: Baseline up to 56 days after last dose of study drug). 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 NCT01602289.

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 8 Jun 2015.

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