Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Breast Neoplasms

Neoplasm Metastasis

Carcinoma

Lung Neoplasms

Small Cell Lung Carcinoma

Triple Negative Breast Neoplasms

Head and Neck Neoplasms

Neoplastic Processes

Breast Diseases

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

25 milligrams (mg) LY3295668 twice daily (BID) administered orally in 21-day cycles.

50 mg LY3295668 BID administered orally in 21-day cycles.

75 mg LY3295668 BID administered orally in 21-day cycles.

25 mg LY3295668 BID administered orally in 21-day cycles.

LY3295668

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)

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.

A Study of AK-01 (LY3295668) in Solid Tumors

A Phase I/II Open-Label Multicenter Study to Evaluate the Safety and Efficacy of AK-01 as Monotherapy in Patients With Locally Advanced or Metastatic Solid Tumors

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

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.

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.

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.

Area under the plasma concentration-time curve for LY3295668 from time zero to 12 hours.

Area under the plasma concentration-time curve for LY3295668 from time zero to 24 hours.

Maximum observed plasma concentration for LY3295668.

Time of maximum observed plasma concentration of LY3295668.

Apparent terminal elimination half-life of LY3295668.

Apparent total plasma clearance of LY3295668.

Apparent volume of distribution of LY3295668.

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.

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.

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.

AurKa Pharma Inc.

Eli Lilly and Company

All participants who received at least one dose of study drug, whether or not they completed all protocol requirements. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.

25 mg LY3295668 BID administered orally in 21-day cycles. Phase 1 and Phase 2 participants have been combined.

25 Milligrams (mg) LY3295668

50 mg LY3295688

75 mg LY3295668 BID administered orally in 21-day cycles

75 mg LY3295688

25 mg LY3295668 twice daily (BID) administered orally in 21-day cycles.

25 Milligrams (mg) LY3295668 (Phase 1)

50 milligrams (mg) LY3295668 BID administered orally in 21-day cycles.

LY3295668: Oral capsules

50 mg LY3295668 (Phase 1)

75 mg LY3295668 BID administered orally in 21-day cycles.

LY3295668: Oral capsules

75 mg LY3295668 (Phase 1)

25 mg LY3295668 BID administered orally in 21-day cycles.

LY3295668: Oral capsules

25 mg LY3295668 (Phase 2)

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Canada

Region of Enrollment

All participants who received at least one dose of study drug.

Study terminated due to sponsor decision.

Chief Medical Officer

LY3295668 Phase 1

All participants who received at least one dose of study drug and experienced a DLT; or received ≥ 38 doses of study drug in Cycle 1 and were not discontinued from the study before completing Cycle 1.

Phase 1: Maximum Tolerated Dose

All patients who received at least 1 dose of AK-01, whether or not they completed all protocol requirements.

Phase 2: Percentage of Participants Who Achieved Partial Response (PR) or Complete Response (CR) [Objective Response Rate (ORR)]

25 mg LY3295668 (Phase 1)

All participants who received at least one dose of study drug, whether or not they completed all protocol requirements.

Phase 1: Number of Participants With One or More Treatment-Emergent Adverse Events

All participants who received at least one dose of study drug whether or not they completed all protocol requirements.

Phase 2: Number of Participants With One or More Treatment-Emergent Adverse Events

Zero participants analyzed due to data not collected.

Phase 2: Pharmacokinetic (PK): Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post-dose (AUC[0-12]) (Phase 2)

Phase 2: PK: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Post-dose (AUC[0-24])

Day 1

Day 15

All participants who received at least one dose of study drug and had evaluable PK data in Phase 2 per protocol.

Phase 2: PK: Maximum Observed Plasma Concentration (Cmax)

Phase 2: PK: Time of Maximum Observed Plasma Concentration (Tmax)

Phase 2: PK: Apparent Terminal Elimination Half-life (t1/2)

Phase 2: PK: Apparent Total Plasma Clearance (CL/F)

Phase 2: PK: Apparent Volume of Distribution (Vz/F)

All participants who received at least one dose of study drug, whether or not they completed all protocol requirements in Phase 1 per protocol.

Spots Global Cancer Trial Database for A Study of AK-01 (LY3295668) in Solid Tumors

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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