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Advanced CancerPhase 1NCT01287546

A Study of LY2875358 in Participants With Advanced Cancer

A Phase 1 study testing LY2875358, LY2875358 + erlotinib and LY2875358 at Part A highest dose in people with Advanced Cancer, run by Eli Lilly and Company at 10 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

The objective of this study is to determine a recommended Phase 2 dose range of LY2875358 that may be safely administered to participants with advanced cancer. In Part A and Part A2 of this study, escalating doses of LY2875358 as monotherapy and in combination with erlotinib will be evaluated for safety and… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer
What is being tested?
LY2875358, LY2875358 + erlotinib and LY2875358 at Part A highest dose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
117 participants
Where
10 sitesUnited States
Study dates
13 Apr 2010to 26 Oct 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

  • Part A: Have histological or cytological evidence of cancer (solid tumor, lymphoma, or multiple myeloma) that is advanced and/or metastatic and an appropriate candidate for experimental therapy
  • Part A2: Histologic or cytologic diagnosis of advanced Non Small Cell Lung Cancer (NSCLC), Stage IIIB with malignant pleural effusion or Stage IV, completed at least 1 prior systemic regimen, and eligible for erlotinib therapy.
  • Part B: Candidate for experimental therapy after standard therapies used or non-eligible for standard therapies. Histological or cytological evidence of 1 of the 5 tumor types:
  • Castrate-resistant prostate cancer (CRPC) with bone metastasis:
  • --Progressive Disease in the setting of castrate level of testosterone
  • Renal Cell Carcinoma (RCC):
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  • --Histologic diagnosis of either clear-cell or papillary RCC (metastatic and unresectable, or bilateral, multifocal, unresectable RCC localized to kidneys).
  • NSCLC:
  • --Histologic or cytologic diagnosis of advanced NSCLC, Stage IIIB with malignant pleural effusion or Stage IV
  • Hepatocellular Carcinoma (HCC)
  • --Histologic or cytologic diagnosis of hepatocellular carcinoma
  • Uveal Melanoma with liver metastasis
  • Part A: Have the presence of measurable or nonmeasurable disease as defined by the RECIST v1.1 (Eisenhauer et al. 2009) or Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007) or have measureable disease for multiple myeloma.
  • Part A2 \& B (RCC, NSCLC, HCC, and uveal melanoma): Have measurable disease as defined by RECIST v1.1.
  • Give written informed consent prior to any study-specific procedures.
  • Adequate organ function.
  • Performance status of less than or equal to 2 on ECOG scale.
  • Discontinued all previous cancer therapies, and any agents that have not received regulatory approval, for at least 21 days and recovered from the acute effects of therapy. Must have discontinued mitomycin-C or nitrosourea therapy for at least 42 days.
  • Reliable and available for the duration of the study and willing to follow study procedures.
  • Males and females (reproductive potential): Use medically approved contraceptive precautions during the study and for 4 months following the last dose of study drug.
  • Females (childbearing potential): Have had a negative serum pregnancy test before the first dose of study drug and not be breast-feeding.
  • Estimated life expectancy that will permit the participants to complete 8 weeks of treatment.

Who cannot join

  • Serious preexisting medical conditions
  • Symptomatic central nervous system malignancy or metastasis (screening not required).
  • Acute or chronic leukemia.
  • Active infection including HIV, hepatitis A, B or C
  • Have second primary malignancy that may affect the interpretation of results.
  • Have received a liver transplant, or have liver cirrhosis with a Child-Pugh Stage of B or C.
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  • Patients with active alcohol abuse, as determined by the treating investigator.
  • Part A2: Unable to swallow tablets. Intolerant of therapy with erlotinib. Concomitant treatment with the cytochrome P450 3A (CYP3A) modulators. Must not have received treatment with any of these modulators within 14 days of study treatment.
  • Have a history of New York Heart Association class ≥3, unstable angina, myocardial infarction 6 months prior to study drug
  • QTc greater than 470 msec.
  • Received previous treatment with any c-MET experimental therapeutic.
  • Part B Expansion Cohort 1 (CRPC):
  • Increasing use of daily doses of opioid analgesics within 28 days prior to enrollment in the study.
  • Neuroendocrine prostate cancer.
  • Patients who have a solitary bone metastasis that has been irradiated are not eligible.
  • Part B Expansion Cohort 6 (LY2875358 plus trametinib in participants with uveal melanoma with liver metastasis): Contra-indications for trametinib

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109-0946

  • Emory University

    Atlanta, Georgia, 30322

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Mayo Clinic of Jacksonville

    Jacksonville, Florida, 32224

  • University of California - San Diego

    La Jolla, California, 92037-0845

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048-5615

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Mayo Clinic

    Rochester, Minnesota, 55902

  • Univ of California San Francisco

    San Francisco, California, 94115

  • UCLA

    Santa Monica, California, 90404

Other trials in United States

About this study

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

The objective of this study is to determine a recommended Phase 2 dose range of LY2875358 that may be safely administered to participants with advanced cancer. In Part A and Part A2 of this study, escalating doses of LY2875358 as monotherapy and in combination with erlotinib will be evaluated for safety and tolerability, respectively. Part B is a dose-confirmation segment for LY2875358 therapy in 5 different types of cancer: nonsquamous non-small cell lung cancer (NSCLC), castrate resistant prostate cancer (CRPC) with bone metastases, renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), or uveal melanoma with liver metastases, and for LY2875358 in combination with trametinib in participants with uveal melanoma with liver metastases.

Read the detailed description

Protocol amendment (November, 2013) expanded Part B to study LY2875358 in combination with trametinib in participants with uveal melanoma with liver metastasis.

Conditions
Advanced Cancer
Being tested
LY2875358, LY2875358 + erlotinib, LY2875358 at Part A highest dose, LY2875358 at Part A highest dose + trametinib

What participants receive

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

  • LY2875358Drug

    Part A Dose escalation of LY2875358 administered intravenously (IV), Day 1 and 15 every 28 days for at least two cycles.

  • LY2875358 + erlotinibDrug

    Part A2 Dose escalation of LY2875358 administered IV, on Day 1 and 15 every 28 days for at least two cycles in combination with daily erlotinib dosing (150 mg) taken orally (PO).

  • LY2875358 at Part A highest doseDrug

    Part B (Dose Exploration): LY2875358 at Part A highest dose administered IV, on Day 1 and 15 every 28 days for at least two cycles.

  • LY2875358 at Part A highest dose + trametinibDrug

    Part B (in combination with trametinib): LY2875358 at Part A highest dose administered IV, on Day 1 and 15 every 28 days for at least two cycles, in combination with trametinib at 2 mg orally once daily

Study groups in NCT01287546
Study groupRoleWhat they receive
LY2875358ExperimentalNot described
Receives: Drug: LY2875358
LY2875358 + erlotinibExperimentalNot described
Receives: Drug: LY2875358 + erlotinib
LY2875358 at Part A highest doseExperimentalNot described
Receives: Drug: LY2875358 at Part A highest dose
LY2875358 at Part A highest dose + trametinibExperimentalNot described
Receives: Drug: LY2875358 at Part A highest dose + trametinib

What is being measured

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

  1. Recommended Phase 2 dose range of LY2875358 monotherapy and in combination with erlotinib

    Measured: Baseline through Cycle 1

Secondary outcomes (6)

  1. Pharmacokinetics: Maximum plasma concentration (Cmax)

    Measured: Days 1, 2, 4, 5, 6, 8, 15, and 22 of Cycle 1. Days 1, 15, and 22 of Cycle 2. Days 1 and 15 of Cycles 3 and beyond, as well as 14 days, 29 days, and 57 days following the final treatment

  2. Number of participants with a tumor response

    Measured: Baseline to study completion (12 months)

  3. Pharmacokinetics: Area under the concentration-time curve (AUC)

    Measured: Days 1, 2, 4, 5, 6, 8, 15, and 22 of Cycle 1. Days 1, 15, and 22 of Cycle 2. Days 1 and 15 of Cycles 3 and beyond, as well as 14 days, 29 days, and 57 days following the final treatment

  4. Time to progression and overall survival

    Measured: Baseline to study completion (12 months)

  5. Pharmacokinetics: Area under the concentration-time curve (AUC) of erlotinib or trametinib in combination with LY2875358

    Measured: Cycle 1

  6. Change from baseline in Brief Pain Inventory (BPI) in Part B: Expansion Cohort 1

    Measured: Baseline to study completion (12 months)

Timeline

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

  1. First posted1 Feb 2011 (estimated)
  2. Study start13 Apr 2010
  3. Primary completion8 Jan 2015
  4. Study completion26 Oct 2016

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
117 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01287546
Sponsor's protocol ID
13298
Other IDs
I4C-MC-JTBA
Status last verified
Feb 2017
First submitted
28 Jan 2011
Last updated
15 Feb 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY2875358, LY2875358 + erlotinib and LY2875358 at Part A highest dose in people with Advanced Cancer, run by Eli Lilly and Company at 10 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 22 inclusion and 16 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 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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?

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?

Recommended Phase 2 dose range of LY2875358 monotherapy and in combination with erlotinib (time frame: Baseline through 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 NCT01287546.

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 15 Feb 2017.

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