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NCT02014116 · REGISTRY CONDITION SEARCH

A Study of LY3009120 in Participants With Advanced Cancer or Cancer That Has Spread to Other Parts of Their Body

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1
Status at capture
TERMINATED
Registry last update
2019-12-27

The main purpose of this study is to see how safe the investigational drug known as LY3009120 is and whether it will work to help people with advanced cancer or cancer that has spread to other parts of the body.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Maximum Tolerated Dose (MTD) of LY3009120

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outcome · POSTED

Number of Participants With Tumor Response

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outcome · POSTED

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 1

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outcome · POSTED

Pharmacokinetics (PK): Maximum Concentration (Cmax) at Steady State of LY3009120 Cycle 1 Day 15

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outcome · POSTED

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 28

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outcome · POSTED

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3009120 Cycle 1 Day 1

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outcome · POSTED

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 15

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outcome · POSTED

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 28

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Advanced or metastatic cancer * Other available therapies have failed to cure the cancer * The cancer that has no proven effective therapy * The cancer can be biopsied (depending on the tumor type and/or the dose of drug received, tumor biopsies may be required) * Able to swallow capsules Exclusion Criteria: * Have active cancer in the brain or spinal cord * Have an active infection of any kind (fungal, viral, or bacterial) * Have a cancer of the blood * Are pregnant or breastfeeding * Have some types of eye problems or impairments
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    LY3009120 50 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.
    intervention Names
    1. Drug: LY3009120 capsule
    label
    Cohort 1 Dose Escalation
    type
    EXPERIMENTAL
  2. description
    LY3009120 100 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.
    intervention Names
    1. Drug: LY3009120 capsule
    label
    Cohort 2 Dose Escalation
    type
    EXPERIMENTAL
  3. description
    LY3009120 200 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.
    intervention Names
    1. Drug: LY3009120 capsule
    label
    Cohort 3 Dose Escalation
    type
    EXPERIMENTAL
  4. description
    LY3009120 400 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met
    intervention Names
    1. Drug: LY3009120 capsule
    label
    Cohort 4 Dose Escalation
    type
    EXPERIMENTAL
  5. description
    LY3009120 500 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met
    intervention Names
    1. Drug: LY3009120 capsule
    label
    Cohort 5 Dose Escalation
    type
    EXPERIMENTAL
  6. description
    LY3009120 300 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met
    intervention Names
    1. Drug: LY3009120 capsule
    label
    Cohort 6 Dose Escalation
    type
    EXPERIMENTAL
  7. description
    LY3009120 300 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.
    intervention Names
    1. Drug: LY3009120 capsule
    label
    Cohort A Dose Confirmation
    type
    EXPERIMENTAL
  8. description
    LY3009120 300 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.
    intervention Names
    1. Drug: LY3009120 capsule
    label
    Cohort B Dose Confirmation
    type
    EXPERIMENTAL
  9. description
    LY3009120 300 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.
    intervention Names
    1. Drug: LY3009120 capsule
    label
    Cohort C Dose Confirmation
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Cohort 1 Dose Escalation
    2. Cohort 2 Dose Escalation
    3. Cohort 3 Dose Escalation
    4. Cohort 4 Dose Escalation
    5. Cohort 5 Dose Escalation
    6. Cohort 6 Dose Escalation
    7. Cohort A Dose Confirmation
    8. Cohort B Dose Confirmation
    9. Cohort C Dose Confirmation
    description
    Administered orally.
    name
    LY3009120 capsule
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
51
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Maximum tolerated dose for the recommended Phase 2 dose (RP2D) of LY3009120 that might be safely administered to participants with advanced and/or metastatic cancer. Dose-limiting toxicity (DLT) is defined as an adverse event (AE) during Cycle 1 (28 days) that was possibly related to the study drug and met 1 of the following criteria: According to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0: ≥Grade 3 non-hematological toxicity except nausea/vomiting, diarrhea, or constipation that can be controlled with appropriate care; Grade 3 elevations of ALT and/or AST lasting fewer than 8 days (without evidence of other hepatic injury); Grade 3 rash that resolves or improves to a Grade 2 or less within 7 days; CTCAE Grade 4 hematological toxicity of \>5 days duration; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia with bleeding; Grade 3 febrile neutropenia.
    measure
    Maximum Tolerated Dose (MTD) of LY3009120
    time Frame
    Cycle 1 (28 Days)
secondary Outcomes
  1. description
    Number of participants with tumor response using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm). PR is defined as at least a 30% decrease in the sum of diameter of target lesions. SD which is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
    measure
    Number of Participants With Tumor Response
    time Frame
    Baseline through progressive disease (Up to 7.36 months)
  2. description
    PK: Maximum concentration of LY3009120 after a single oral dose Cycle 1 Day 1.
    measure
    Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 1
    time Frame
    Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 hours (h) post-dose
  3. description
    PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 15.
    measure
    Pharmacokinetics (PK): Maximum Concentration (Cmax) at Steady State of LY3009120 Cycle 1 Day 15
    time Frame
    Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
  4. description
    PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 28.
    measure
    Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 28
    time Frame
    Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
  5. description
    PK: area under the concentration versus time curve \[0-∞\] of LY3009120 after a single oral dose Cycle 1 Day1.
    measure
    Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3009120 Cycle 1 Day 1
    time Frame
    Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
  6. description
    PK: area under the concentration versus time curve from time 0 to the end of the twice daily dosing interval at steady state \[AUC0-τ\].
    measure
    Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 15
    time Frame
    Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
  7. description
    PK: area under the concentration versus time curve from time 0 to the end of the twice daily dosing interval at steady state AUC\[0-τ\].
    measure
    Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 28
    time Frame
    Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
Full study description
brief Summary
The main purpose of this study is to see how safe the investigational drug known as LY3009120 is and whether it will work to help people with advanced cancer or cancer that has spread to other parts of the body.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
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      edge id
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      requested nct id
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      primary nct id
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      source kind
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      payload sha256
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      payload
      clinical indication matching status
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      end exclusive
      true
      id
      nct-edge-3020e04c9610e50080e2
      link basis
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      nct id
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      occurrences
      1. context exact
        NCT02014116
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        exact text
        NCT02014116
        start
        0
      offset unit
      unicode_code_points
      query cond
      Small Intestine Cancer
      query disease state id
      ds-small-intestine-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-small-intestine-cancer-000.json
      source file sha256
      69c40ed34b17434f684079ec5635264bc5ad292871a86b835704fc99fa9d8157
      source json pointer
      /studies/35/protocolSection/identificationModule/nctId
      source kind
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      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
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    Preserved source evidence · Not medical advice