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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02857270
Registration number
NCT02857270
Ethics application status
Date submitted
3/08/2016
Date registered
5/08/2016
Date last updated
22/11/2022
Titles & IDs
Public title
A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer
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Scientific title
A Phase 1 Study of an ERK1/2 Inhibitor (LY3214996) Administered Alone or in Combination With Other Agents in Advanced Cancer
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Secondary ID [1]
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I8S-MC-JUAB
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Secondary ID [2]
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16419
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer
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Metastatic Melanoma
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Metastatic Non-small Cell Lung Cancer
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Colorectal Cancer
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Condition category
Condition code
Cancer
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Lung - Non small cell
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Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - LY3214996
Treatment: Drugs - Midazolam
Treatment: Drugs - Abemaciclib
Treatment: Drugs - Nab-paclitaxel
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Encorafenib
Treatment: Drugs - Cetuximab
Experimental: LY3214996 Dose Escalation - LY3214996 given orally once a day (or twice a day) for 21 days.
Experimental: LY3214996 + Midazolam - (Preliminary Drug-Drug Interactions [DDI])
LY3214996 given orally (once a day) and midazolam given orally on cycle 1 day 1 and cycle 1 day 16 (21 day cycles except cycle 1 only = 22 days).
Experimental: LY3214996 Dose Expansion - LY3214996 given orally (once a day) during each 21 day cycle.
Experimental: LY3214996 + Abemaciclib - Dose Escalation and Expansion- LY3214996 given orally (dose timing will be determined) and abemaciclib given orally (single dose given during lead in period) twice a day every 12 hours during 21 day cycle.
Experimental: LY3214996 + Nab-Paclitaxel + Gemcitabine - Dose Escalation and Expansion- LY3214996 given orally (dose timing will be determined) and nab-paclitaxel given intravenously (IV) on day 1, 8, and 15 and gemcitabine IV on day 1, 8, and 15 during each 28 day cycle.
Experimental: LY3214996 + Encorafenib + Cetuximab - Dose Escalation and Expansion- LY3214996 given orally, encorafenib given orally and cetuximab given IV.
Experimental: Japan Part 1 - LY3214996 given orally.
Experimental: Japan Part 2 - LY3214996 given orally and abemaciclib given orally.
Treatment: Drugs: LY3214996
Administered orally
Treatment: Drugs: Midazolam
Administered orally
Treatment: Drugs: Abemaciclib
Administered orally
Treatment: Drugs: Nab-paclitaxel
Administered IV
Treatment: Drugs: Gemcitabine
Administered IV
Treatment: Drugs: Encorafenib
Administered orally
Treatment: Drugs: Cetuximab
Administered IV
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants with LY3214996 Dose Limiting Toxicities (DLTs)
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Assessment method [1]
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Timepoint [1]
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Cycle 1 (21 Days)
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Secondary outcome [1]
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Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC) of LY3214996 Administered as Monotherapy and when Administered in Combination with Nab-Paclitaxel Plus Gemcitabine, Abemaciclib and Encorafenib Plus Cetuximab
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Assessment method [1]
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Timepoint [1]
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Cycle 1 Day 1 through Cycle 2 Day 1 (up to 28 Day Cycles)
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Secondary outcome [2]
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PK: AUC of Gemcitabine when Administered with LY3214996
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Assessment method [2]
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Timepoint [2]
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Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles)
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Secondary outcome [3]
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PK: AUC of Nab-Paclitaxel when Administered with LY3214996
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Assessment method [3]
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Timepoint [3]
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Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles)
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Secondary outcome [4]
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PK: AUC of Abemaciclib and its Metabolites when Administered with LY3214996
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Assessment method [4]
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Timepoint [4]
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Cycle 1 Day 1 through Cycle 2 Day 1 (up to 22 Day Cycles)
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Secondary outcome [5]
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PK: AUC of Encorafenib when Administered with LY3214996
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Assessment method [5]
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Timepoint [5]
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Cycle 1 Day 1 through Cycle 2 Day 1 (up to 22 Day Cycles)
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Secondary outcome [6]
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PK: AUC of Cetuximab when Administered with LY3214996
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Assessment method [6]
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Timepoint [6]
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Cycle 1 Day 1 through Cycle 2 Day 1 (up to 22 Day Cycles)
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Secondary outcome [7]
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PK: AUC of Midazolam and its 1'-Hydroxymidazolam Metabolite when Administered Alone and in Combination with LY3214996
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Assessment method [7]
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Timepoint [7]
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Cycle 1 Day 1 through Cycle 1 Day 16 (21 Day Cycles)
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Secondary outcome [8]
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Objective Response Rate (ORR): Percentage of Participants With a Complete (CR) or Partial Response (PR)
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Assessment method [8]
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Timepoint [8]
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Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Estimated up to 6 Months)
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Secondary outcome [9]
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Duration of Response (DoR)
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Assessment method [9]
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Timepoint [9]
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Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 12 Months)
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Secondary outcome [10]
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Time to First Response (TTR)
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Assessment method [10]
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Timepoint [10]
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Baseline to Date of CR or PR (Estimated up to 6 Months)
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Secondary outcome [11]
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Progression Free Survival (PFS)
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Assessment method [11]
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Timepoint [11]
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Baseline to Progressive Disease or Death of Any Cause (Estimated up to 12 Months)
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Secondary outcome [12]
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Disease Control Rate (DCR): Percentage of Participants who Exhibit Stable Disease (SD), CR or PR
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Assessment method [12]
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Timepoint [12]
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Baseline through Measured Progressive Disease (Estimated up to 6 Months)
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Secondary outcome [13]
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Overall Survival (OS) (Dose Expansion Arms Only)
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Assessment method [13]
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Timepoint [13]
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Baseline to Date of Death from Any Cause (Estimated up to 2 Years)
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Eligibility
Key inclusion criteria
- Have advanced or metastatic cancer (solid tumors) and be an appropriate candidate for
experimental therapy.
- Part B (No Longer Enrolling Participants): Have advanced or metastatic cancer
with an activating mitogen-activated protein kinase pathway alteration, BRAF
mutant metastatic melanoma refractory to or relapsed after treatment with RAF
and/or MEK inhibitors, metastatic melanoma with a NRAS mutation, or BRAF mutant
NSCLC.
- Part C: Advanced, unresectable cancer (dose escalation) and advanced,
unresectable, or metastatic non-small cell lung cancer with a BRAF or RAS
mutation, or NRAS mutant melanoma (dose expansion).
- Part D (No Longer Enrolling Participants): Have metastatic pancreatic ductal
adenocarcinoma (dose escalation and dose expansion).
- Part E: Metastatic BRAF V600E colorectal cancer.
- Have discontinued previous treatments for cancer and have resolution, except where
otherwise stated in the inclusion criteria, of all clinically significant toxic
effects of prior chemotherapy, surgery, or radiotherapy to Grade =1 by National Cancer
Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
- Have adequate organ function.
- Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG)
scale.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Have serious preexisting medical conditions.
- Have a known human immunodeficiency virus (HIV) infection or known
activated/reactivated hepatitis A, B, or C.
- Have symptomatic central nervous system malignancy or metastasis.
- Have current hematologic malignancies, acute or chronic leukemia.
- Have a second primary malignancy that in the judgment of the investigator or Lilly may
affect the interpretation of results.
- Have prior malignancies. Participants with carcinoma in situ of any origin and
participants with prior malignancies who are in remission and whose likelihood of
recurrence is very low, as judged by the Lilly clinical research physician, are
eligible for this study.
- Have a mean QT interval corrected for heart rate (QTc) of =470 milliseconds on
screening electrocardiogram (ECG) as calculated using the Bazett's formula at several
consecutive days of assessment.
- Have participated, within the last 28 days in a clinical trial involving an
investigational product or are currently enrolled in a clinical trial involving an
investigational product or any other type of medical research judged not to be
scientifically or medically compatible with this study.
- Have previously completed or withdrawn from this study or any other study
investigating an ERK1/2 inhibitor.
- If female, is pregnant, breastfeeding, or planning to become pregnant.
- Have history or findings of central or branch retinal artery or venous occlusion with
significant vision loss or other retinal diseases that cause current visual impairment
or would likely cause visual impairment over the time period of the study.
- Currently using concomitant medications that are strong inhibitors or inducers of
CYP3A4.
- Part C: have serious and/or uncontrolled preexisting medical condition(s) that, in the
judgment of the investigator, would preclude participation in this study, including
interstitial lung disease (ILD) or severe dyspnea at rest or requiring oxygen therapy.
- Part C4 NRAS Melanoma: have previously completed or withdrawn from a study
investigating a MEK inhibitor.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/09/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
24/10/2022
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Sample size
Target
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Accrual to date
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Final
210
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Recruitment in Australia
Recruitment state(s)
NSW,WA
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Recruitment hospital [1]
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St Vincent's Hospital - Sydney
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Recruitment hospital [2]
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Linear Clinical Research Ltd - Nedlands
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Recruitment postcode(s) [1]
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2010 - Sydney
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Recruitment postcode(s) [2]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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District of Columbia
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Massachusetts
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Country [4]
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United States of America
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State/province [4]
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New Hampshire
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Country [5]
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United States of America
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State/province [5]
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Pennsylvania
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Country [6]
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United States of America
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State/province [6]
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Tennessee
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Country [7]
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United States of America
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State/province [7]
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Texas
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Country [8]
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France
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State/province [8]
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Villejuif Cedex
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Country [9]
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Japan
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State/province [9]
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Shizuoka
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Country [10]
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Japan
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State/province [10]
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Tokyo
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine the safety of an extracellular signal regulated
kinase (ERK1/2) inhibitor LY3214996 administered alone or in combination with other agents in
participants with advanced cancer.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02857270
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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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)
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Address
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Eli Lilly and Company
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02857270
Download to PDF