This two-part study consists of a phase 1 dose escalation study in participants with locally advanced or metastatic solid tumors, and a phase 2 portion in up to 3 groups with either small cell lung cancer, breast cancer and/or one other solid tumor type.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Oral capsules
Cross Cancer Institute
Edmonton, Alberta, Canada
Jewish General Hospital
Montreal, Quebec, Canada
McGill University
Montreal, Quebec, Canada
Phase 1: Maximum Tolerated Dose
Maximum Tolerated Dose (MTD) was defined as the dose immediately below the dose at which ≥2/3, ≥2/6, or ≥3/9 participants in a cohort experienced a dose limiting toxicity (DLT) during the first 21 days of treatment (Cycle 1) in Phase 1.
Time frame: Cycle 1 (21 days)
Phase 2: Percentage of Participants Who Achieved Partial Response (PR) or Complete Response (CR) [Objective Response Rate (ORR)]
Objective response rate (ORR) was defined as a percentage of responders who achieved complete response or partial response (CR+PR) as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1). Complete response (CR) is defined as disappearance of all target (and non-target) lesions, and no appearance of new lesion. Partial response (PR) was defined as at least a 30% decrease in the sum of longest diameters (LD) of target lesions, taking as reference the baseline sum of LD, no progression of non-target lesions, and no appearance of new lesions.
Time frame: Baseline to Objective Disease Progression (Up to 11 months)
Phase 1: Number of Participants With One or More Treatment-Emergent Adverse Events
A treatment-emergent adverse event (AE) is an AE that started or worsened (increased in severity) from the treatment start date to 30 days after the treatment end date. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.
Time frame: Cycle 1 Day 1 through 30 Days After Treatment End Date (Up to 29 Months)
Phase 2: Number of Participants With One or More Treatment-Emergent Adverse Events
A treatment-emergent adverse event (AE) is an AE that started or worsened (increased in severity) from the treatment start date to 30 days after the treatment end date. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.
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Time frame: Cycle 1 Day 1 through 30 Days After Treatment End Date (Up to 29 Months)
Phase 2: Pharmacokinetic (PK): Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post-dose (AUC[0-12]) (Phase 2)
Area under the plasma concentration-time curve for LY3295668 from time zero to 12 hours.
Time frame: Cycle 1: Day 1 and Day 15: Predose, 1, 2, 4, 6, and 8 - 12 hours postdose; Cycle 1: Day 2 and Day 8 predose
Phase 2: PK: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Post-dose (AUC[0-24])
Area under the plasma concentration-time curve for LY3295668 from time zero to 24 hours.
Time frame: Cycle 1: Day 1 and Day 15: Predose, 1, 2, 4, 6, and 8-12 hours post-dose; Cycle 1: Day 2 and Day 8 Predose
Phase 2: PK: Maximum Observed Plasma Concentration (Cmax)
Maximum observed plasma concentration for LY3295668.
Time frame: Cycle 1: Day 1 and Day 15: Predose, 1, 2, 4, 6, and 8 hours post-dose
Phase 2: PK: Time of Maximum Observed Plasma Concentration (Tmax)
Time of maximum observed plasma concentration of LY3295668.
Time frame: Cycle 1: Day 1 and Day 15: Predose, 1, 2, 4, 6, and 8 hours post-dose
Phase 2: PK: Apparent Terminal Elimination Half-life (t1/2)
Apparent terminal elimination half-life of LY3295668.
Time frame: Cycle 1: Day 1 and Day 15: Predose, 1, 2, 4, 6, and 8-12 hours post-dose; Cycle 1: Day 2 and Day 8 Predose
Phase 2: PK: Apparent Total Plasma Clearance (CL/F)
Apparent total plasma clearance of LY3295668.
Time frame: Cycle 1: Day 1 and Day 15: Predose, 1, 2, 4, 6, and 8 -12 hours post-dose; Cycle 1: Day 2 and Day 8 Predose
Phase 2: PK: Apparent Volume of Distribution (Vz/F)
Apparent volume of distribution of LY3295668.
Time frame: Cycle 1: Day 1 and Day 15: Predose, 1, 2, 4, 6, and 8 -12 hours post-dose; Cycle 1: Day 2 and Day 8 Predose
Phase 1: Number of Participants With Worst Post-Baseline Grade >=3 White Blood Cell Count (WBC)
Presented are participants with the worst post-baseline WBC Grade \>= 3 using the National Cancer Institute (NCI) Common Terminology Criteria For Adverse Events version 4.03 (CTCAE v4.03). where Grade 1: \< Lower Limit Normal (LLN) - 3000/mm3; \<LLN - 3.0 x10e9/L, Grade 2: \<3000 - 2000/mm3; \<3.0 - 2.0 x10e9/L, Grade 3: \<2000 - 1000/mm3; \<2.0 1.0 x10e9/L, Grade 4: \<1000/mm3; \<1.0 x10e9/L.
Time frame: Cycle 1 Day 1 through 30 Days After Treatment End Date (Up to 29 Months)
Phase 1: Number of Participants With Worst Post-Baseline Grade >=3 Neutrophils (Segmented and Blended)
Presented are participants with the worst post-baseline neutrophils Grade \>=3 using the NCI-CTCAE v4.03 where Grade 1: \< LLN - 1500/mm3; \<LLN - 1.5 x10e9/L, Grade 2: \<1500 - 1000/mm3; \<1.5 - 1.0 x10e9/L, Grade 3: \<1000 - 500/mm3; \<1.0 - 0.5 x10e9/L, Grade 4: \<500/mm3; \<0.5 x 10e9/L.
Time frame: Cycle 1 Day 1 through 30 Days After Treatment End Date (Up to 29 Months)
Phase 1: Number of Participants With Worst Post-Baseline Grade >=3 Lymphocytes
Presented are participants with the worst post-baseline lymphocytes Grade \>=3 using the NCI-CTCAE version 4.03 where Grade 1: \<LLN - \<800/mm3, \<LLN - 0.8 x 10e9/L, Grade 2: \<800 - 500/mm3; \<0.8 - 0.5 x 10e9/L, Grade 3: \<500 - 200/mm3; \<0.5 - 0.2 x 10e9/L, \<200mm3; \<0.2 x 10e9/L.
Time frame: Cycle 1 Day 1 through 30 Days After Treatment End Date (Up to 29 Months)