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NCT02711345 · REGISTRY CONDITION SEARCH

A Phase I Clinical Study With Investigational Compound LTT462 in Adult Patients With Specific Advanced Cancers.

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
2019-09-19

A phase I study of LTT462 in patients with advanced solid tumors that harbor MAPK pathway alterations.

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

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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outcome · POSTED

Percentage of Participants With Dose Limiting Toxicities (DLTs)

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outcome · POSTED

Percentage of Participants With at Least One Dose Reduction

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outcome · POSTED

Percentage of Participants With at Least One Dose Interruptions

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outcome · POSTED

Dose Intensity Received by Participants

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outcome · POSTED

Percentage of Participants With Overall Response Rate (ORR)

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outcome · POSTED

Percentage of Participants With Disease Control Rate (DCR)

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outcome · POSTED

Duration of Response (DOR)

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outcome · POSTED

Progression Free Survival (PFS)

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outcome · POSTED

Overall Survival (OS) - Only for Dose Expansion Phase

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outcome · POSTED

The Maximum (Peak) Observed Plasma, Blood, Serum, or Other Body Fluid Drug Concentration (Cmax) After Single Dose Administration of LTT462

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outcome · POSTED

Area Under the Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of LTT462

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outcome · POSTED

The Time to Reach Maximum (Peak) Plasma, Blood, Serum, or Other Body Fluid Drug Concentration (Tmax) After Single Dose Administration of LTT462

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outcome · POSTED

Elimination Half-life (T1/2) of LTT462

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outcome · POSTED

The Area Under the Curve Calculated to the End of a Dosing Interval (Tau) at Steady-state (AUCtau) of LTT462

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outcome · POSTED

Accumulation Ratio (Racc) of LTT462

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outcome · POSTED

Changes From Baseline in Relative Quantity (RQ) of Dual Specificity Phosphatase 6 (DUSP6) in Tumor Tissue and in Blood

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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: * Patient (male or female) ≥12 years of age * ECOG (Eastern Cooperative Oncology Group) performance status ≤1 * Must have progressed following standard therapy, or for whom, in the opinion of the Investigator, no effective standard therapy exists, is tolerated or appropriate. * Patients must be willing and able to undergo study required biopsies. * Presence of at least one measurable lesion according to RECIST v1.1. * Documented MAPK pathway alteration Exclusion Criteria: * Prior treatment with ERK inhibitors. * History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO. * Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures. * Patients receiving proton pump inhibitors (PPI) which cannot be discontinued 3 days prior to the start study treatment and for the duration of the study. * Patients with malignant disease other than that being treated in the study. * Clinically significant cardiac disease. Other protocol-defined exclusion criteria may apply.
healthy Volunteers
false
minimum Age
12 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Drug: LTT462
    label
    Escalation
    type
    EXPERIMENTAL
  2. intervention Names
    1. Drug: LTT462
    label
    Expansion Group 1
    type
    EXPERIMENTAL
  3. intervention Names
    1. Drug: LTT462
    label
    Expansion Group 2
    type
    EXPERIMENTAL
  4. intervention Names
    1. Drug: LTT462
    label
    Expansion Group 3
    type
    EXPERIMENTAL
  5. intervention Names
    1. Drug: LTT462
    label
    Expansion Group 4
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Escalation
    2. Expansion Group 1
    3. Expansion Group 2
    4. Expansion Group 3
    5. Expansion Group 4
    description
    ERK Inhibitor
    name
    LTT462
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
65
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    An adverse events is defined as the appearance of (or worsening of any pre-existing) undesirable signs, symptoms, or medical conditions that occur after participant's signed informed consent has been obtained. A SAE is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above.
    measure
    Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
    time Frame
    Up to 2.8 years
  2. description
    Percentage of participants with dose limiting toxicity were reported.
    measure
    Percentage of Participants With Dose Limiting Toxicities (DLTs)
    time Frame
    Up to 2.8 years
  3. description
    Percentage of participants with at least one dose reduction were reported.
    measure
    Percentage of Participants With at Least One Dose Reduction
    time Frame
    Up to 2.8 years
  4. description
    Percentage of participants with at least dose interruptions were reported.
    measure
    Percentage of Participants With at Least One Dose Interruptions
    time Frame
    Up to 2.8 years
  5. description
    Dose intensity of LTT462 received by treatment group was reported.
    measure
    Dose Intensity Received by Participants
    time Frame
    Up to 2.8 years
secondary Outcomes
  1. description
    Percentage of participants with overall response rate were reported.
    measure
    Percentage of Participants With Overall Response Rate (ORR)
    time Frame
    Every 2 cycles after starting LTT462 treatment until end of treatment (Up to 2.8 years)
  2. description
    Percentage of participants with disease control rate were reported.
    measure
    Percentage of Participants With Disease Control Rate (DCR)
    time Frame
    Every 2 cycles after starting LTT462 treatment until end of treatment (Up to 2.8 years)
  3. description
    DOR is defined as the time between the date of the first documented response (complete response \[CR\] or partial response \[PR\]) and the date of progression.
    measure
    Duration of Response (DOR)
    time Frame
    Every 2 cycles after starting LTT462 treatment until end of treatment (Up to 2.8 years)
  4. description
    Median time for progression free survival was reported.
    measure
    Progression Free Survival (PFS)
    time Frame
    Every 2 cycles after starting LTT462 treatment until end of treatment (Up to 2.8 years)
  5. description
    Median time for overall survival, only for dose expansion phase was reported.
    measure
    Overall Survival (OS) - Only for Dose Expansion Phase
    time Frame
    Every 2 cycles after starting LTT462 treatment until end of treatment (Up to 2.8 years)
  6. description
    Cmax is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration expressed in mass x volume-1.
    measure
    The Maximum (Peak) Observed Plasma, Blood, Serum, or Other Body Fluid Drug Concentration (Cmax) After Single Dose Administration of LTT462
    time Frame
    day 1, day 15
  7. description
    AUClast is the area under the curve from time zero to the last measurable concentration sampling time calculated by mass \* time \*volume\^-1
    measure
    Area Under the Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of LTT462
    time Frame
    Cycle 1 Days 1, 2, 3, 8, 15 and 16; Cycle 2 day 1 and 15; Cycle 3 Day 1; Cycle 5 Day 1
  8. description
    Tmax is the time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration.
    measure
    The Time to Reach Maximum (Peak) Plasma, Blood, Serum, or Other Body Fluid Drug Concentration (Tmax) After Single Dose Administration of LTT462
    time Frame
    day 1, day 15
  9. description
    T1/2 is the Elimination half-life.
    measure
    Elimination Half-life (T1/2) of LTT462
    time Frame
    Cycle 1 Days 1, 2, 3, 8, 15 and 16; Cycle 2 day 1 and 15; Cycle 3 Day 1; Cycle 5 Day 1
  10. description
    AUCtau is the area under the curve calculated to the end of a dosing interval (tau) at steady-state calculated by formula amount \*time \* volume\^-1
    measure
    The Area Under the Curve Calculated to the End of a Dosing Interval (Tau) at Steady-state (AUCtau) of LTT462
    time Frame
    Cycle 1 Days 1, 2, 3, 8, 15 and 16; Cycle 2 day 1 and 15; Cycle 3 Day 1; Cycle 5 Day 1
  11. description
    Racc is the accumulation ratio calculated by AUCtau ratio Day 15 versus Day 1.
    measure
    Accumulation Ratio (Racc) of LTT462
    time Frame
    Cycle 1 Days 1, 2, 3, 8, 15 and 16; Cycle 2 day 1 and 15; Cycle 3 Day 1; Cycle 5 Day 1
  12. description
    Assessment of Pharmacodynamic (PD) effects of LTT462 in tumor, pre- and post- treatment tumor biopsies were examined for expression of DUSP6. For assessment of PD effects in blood, levels of DUSP6 were measured in blood samples.
    measure
    Changes From Baseline in Relative Quantity (RQ) of Dual Specificity Phosphatase 6 (DUSP6) in Tumor Tissue and in Blood
    time Frame
    Cycle 1 Days 1, 2, 3, 15 and 16
Full study description
brief Summary
A phase I study of LTT462 in patients with advanced solid tumors that harbor MAPK pathway alterations.
Source references
Source notices and limitations
    Discovery and provenance
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      payload
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      id
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      occurrences
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      query cond
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      query disease state id
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      source file
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      source file sha256
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    Preserved source evidence · Not medical advice