CompletedNCT03092934Updated Jul 2, 2021Results posted

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

A Phase 1/2 interventional study of LY3295668 in Neoplasms, Neoplasm Metastasis and Triple Negative Breast Neoplasms, sponsored by Eli Lilly and Company. Completed at 3 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-02.

Sponsored by Eli Lilly and Company · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 13
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study summary

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.

Conditions studied

Neoplasms
Neoplasm Metastasis
Triple Negative Breast Neoplasms
Head and Neck Neoplasms
Breast Neoplasms
Solid Tumor, Adult
Small Cell Lung Carcinoma

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In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 13 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Have received at least 1 but no more than 4 prior systemic therapies
Have adequate organ function
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
Have estimated life expectancy greater than or equal to (≥)12 weeks
Have fully recovered from radiation therapy or surgery, and are recovering from any acute adverse effects of other cancer therapies
Have discontinued all chemotherapy, investigational therapy, molecularly-targeted therapy, and cancer-related hormonal therapy at least 14 days prior, biologic or immunotherapeutic therapy at least 21 days prior, or mitomycin-C or nitrosoureas at least 6 weeks prior
Female participants with reproductive potential agree to use 2 forms of highly effective contraception during the study and for the following 3 months
Male participants must use a barrier method of contraception during the study and for the following 3 months

Phase 1

Have evidence of a solid tumor that is locally advanced and/or metastatic (excluding primary brain tumor)

Phase 2

Have disease measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
Have evidence of a solid tumor that is locally advanced and/or metastatic, and in:
- Small Cell Lung Cancer (SCLC), must have failed platinum-containing therapy
- Breast Cancer, be Estrogen Receptor positive and/or Progesterone Receptor positive, but Human Epidermal Growth Factor Receptor 2 (HER2) negative, and must have failed a hormone therapy and a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor
- Triple negative breast cancer (TNBC) and failed standard therapy
- Squamous cell cancers of the head neck associated with the human papilloma virus (HPV), and have failed standard therapy
- Other solid tumor type that has been approved by the sponsor

Exclusion criteria

Exclusion Criteria:

Have symptomatic central nervous system (CNS) metastasis (unless asymptomatic and not current receiving corticosteroids) or a primary tumor of the CNS
Have a medical condition that precludes participation (swallowing disorder, organ transplant, pregnant or nursing, HIV, active Hepatitis B or C, cardiac disease, history of major surgery in upper gastrointestinal (GI) tract or GI disease, hypokalemia, hypomagnesaemia or hypocalcaemia that cannot be controlled)

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 13 participants (actual)

Study arms

Experimental
25 milligrams (mg) LY3295668 (Phase 1)
25 milligrams (mg) LY3295668 twice daily (BID) administered orally in 21-day cycles.
Drug: LY3295668
Experimental
50 mg LY3295668 (Phase 1)
50 mg LY3295668 BID administered orally in 21-day cycles.
Drug: LY3295668
Experimental
75 mg LY3295668 (Phase 1)
75 mg LY3295668 BID administered orally in 21-day cycles.
Drug: LY3295668
Experimental
25 mg LY3295668 (Phase 2)
25 mg LY3295668 BID administered orally in 21-day cycles.
Drug: LY3295668

Interventions

DrugLY3295668
Oral capsules
Also known as: AK-01, Erbumine

What researchers measure

Primary outcomes

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)

Secondary outcomes

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.
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)

Results

Posted Jul 2, 2021

Limitations and caveats

Study terminated due to sponsor decision.

Participant flow

Participant flow — Overall Study
Milestone	25 Milligrams (mg) LY3295668 (Phase 1)	50 mg LY3295668 (Phase 1)	75 mg LY3295668 (Phase 1)	25 mg LY3295668 (Phase 2)
Started	8	2	2	1
Received at least one dose of study drug	8	2	2	1
Completed	8	2	2	1
Not completed	0	0	0	0

Outcome measures

PrimaryPhase 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)
Reported as:: Number · milligram (mg)

Phase 1: Maximum Tolerated Dose
milligram (mg)	LY3295668 Phase 1
Phase 1: Maximum Tolerated Dose	25

PrimaryPhase 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)
Reported as:: Number · percentage of participants

Phase 2: Percentage of Participants Who Achieved Partial Response (PR) or Complete Response (CR) [Objective Response Rate (ORR)]
percentage of participants	25 mg LY3295668 (Phase 2)
Phase 2: Percentage of Participants Who Achieved Partial Response (PR) or Complete Response (CR) [Objective Response Rate (ORR)]	0

SecondaryPhase 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)
Reported as:: Count of participants · Participants

Phase 1: Number of Participants With One or More Treatment-Emergent Adverse Events
Participants	25 mg LY3295668 (Phase 1)	50 mg LY3295668 (Phase 1)	75 mg LY3295668 (Phase 1)
Phase 1: Number of Participants With One or More Treatment-Emergent Adverse Events	7	2	2

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

Time frame:: Cycle 1 Day 1 through 30 Days After Treatment End Date (Up to 29 Months)
Reported as:: Count of participants · Participants

Phase 2: Number of Participants With One or More Treatment-Emergent Adverse Events
Participants	25 mg LY3295668 (Phase 2)
Phase 2: Number of Participants With One or More Treatment-Emergent Adverse Events	1

SecondaryPhase 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

No measurements were reported for this outcome.

SecondaryPhase 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

No measurements were reported for this outcome.

SecondaryPhase 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
Reported as:: Geometric mean · micrograms per liter (µg/L)

Phase 2: PK: Maximum Observed Plasma Concentration (Cmax)
micrograms per liter (µg/L)	25 mg LY3295668 (Phase 2)
Day 1	NA ± NA
Day 15	NA ± NA

SecondaryPhase 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
Reported as:: Geometric mean · hours

Phase 2: PK: Time of Maximum Observed Plasma Concentration (Tmax)
hours	25 mg LY3295668 (Phase 2)
Day 1	NA ± NA
Day 15	NA ± NA

SecondaryPhase 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

No measurements were reported for this outcome.

SecondaryPhase 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

No measurements were reported for this outcome.

SecondaryPhase 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

No measurements were reported for this outcome.

SecondaryPhase 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)
Reported as:: Count of participants · Participants

Phase 1: Number of Participants With Worst Post-Baseline Grade >=3 White Blood Cell Count (WBC)
Participants	25 mg LY3295668 (Phase 1)	50 mg LY3295668 (Phase 1)	75 mg LY3295668 (Phase 1)
Phase 1: Number of Participants With Worst Post-Baseline Grade >=3 White Blood Cell Count (WBC)	1	0	0

SecondaryPhase 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)
Reported as:: Count of participants · Participants

Phase 1: Number of Participants With Worst Post-Baseline Grade >=3 Neutrophils (Segmented and Blended)
Participants	25 mg LY3295668 (Phase 1)	50 mg LY3295668 (Phase 1)	75 mg LY3295668 (Phase 1)
Phase 1: Number of Participants With Worst Post-Baseline Grade >=3 Neutrophils (Segmented and Blended)	1	0	1

SecondaryPhase 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)
Reported as:: Count of participants · Participants

Phase 1: Number of Participants With Worst Post-Baseline Grade >=3 Lymphocytes
Participants	25 mg LY3295668 (Phase 1)	50 mg LY3295668 (Phase 1)	75 mg LY3295668 (Phase 1)
Phase 1: Number of Participants With Worst Post-Baseline Grade >=3 Lymphocytes	2	1	0

Adverse events

Collected over Up to 29 Months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
25 Milligrams (mg) LY3295668	1/9 (11.1%)	4/9 (44.4%)	9/9 (100%)
50 mg LY3295688	0/2 (0%)	1/2 (50%)	2/2 (100%)
75 mg LY3295688	0/2 (0%)	2/2 (100%)	2/2 (100%)

Most frequent serious events

Showing 10 of 11

Most frequent serious events
Event	25 Milligrams (mg) LY3295668	50 mg LY3295688	75 mg LY3295688
Corneal depositsEye disorders	0/9	0/2	1/2
DiarrhoeaGastrointestinal disorders	0/9	1/2	1/2
StomatitisGastrointestinal disorders	0/9	1/2	0/2
Mucosal inflammationGeneral disorders	0/9	0/2	1/2
Pericardial effusionCardiac disorders	1/9	0/2	0/2
InfluenzaInfections and infestations	1/9	0/2	0/2
Pneumocystis jirovecii pneumoniaInfections and infestations	1/9	0/2	0/2
PneumoniaInfections and infestations	1/9	0/2	0/2
Adenocarcinoma of colonNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/9	0/2	0/2
PresyncopeNervous system disorders	1/9	0/2	0/2

Most frequent other events

Showing 10 of 86

Most frequent other events
Event	25 Milligrams (mg) LY3295668	50 mg LY3295688	75 mg LY3295688
DiarrhoeaGastrointestinal disorders	4/9	1/2	2/2
NauseaGastrointestinal disorders	2/9	0/2	2/2
Mucosal inflammationGeneral disorders	1/9	2/2	2/2
AlopeciaSkin and subcutaneous tissue disorders	2/9	1/2	2/2
FatigueGeneral disorders	5/9	0/2	0/2
AnaemiaBlood and lymphatic system disorders	2/9	1/2	0/2
NeutropeniaBlood and lymphatic system disorders	0/9	0/2	1/2
Eye pruritusEye disorders	0/9	1/2	0/2
Lacrimation increasedEye disorders	0/9	1/2	0/2
Night blindnessEye disorders	0/9	1/2	0/2

Baseline characteristics

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

Age, Categorical
Age, Categorical(Participants)	25 Milligrams (mg) LY3295668 (Phase 1)	50 mg LY3295668 (Phase 1)	75 mg LY3295668 (Phase 1)	25 mg LY3295668 (Phase 2)	Total
<=18 years	0	0	0	0	0
Between 18 and 65 years	7	0	0	0	7
>=65 years	1	2	2	1	6

Sex: Female, Male
Sex: Female, Male(Participants)	25 Milligrams (mg) LY3295668 (Phase 1)	50 mg LY3295668 (Phase 1)	75 mg LY3295668 (Phase 1)	25 mg LY3295668 (Phase 2)	Total
Female	4	1	2	1	8
Male	4	1	0	0	5

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	25 Milligrams (mg) LY3295668 (Phase 1)	50 mg LY3295668 (Phase 1)	75 mg LY3295668 (Phase 1)	25 mg LY3295668 (Phase 2)	Total
Hispanic or Latino	0	0	0	0	0
Not Hispanic or Latino	8	2	2	1	13
Unknown or Not Reported	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	25 Milligrams (mg) LY3295668 (Phase 1)	50 mg LY3295668 (Phase 1)	75 mg LY3295668 (Phase 1)	25 mg LY3295668 (Phase 2)	Total
American Indian or Alaska Native	0	0	0	0	0
Asian	1	0	0	0	1
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	0	0	0	0	0
White	5	2	2	1	10
More than one race	0	0	0	0	0
Unknown or Not Reported	2	0	0	0	2

Region of Enrollment
Region of Enrollment(Participants)	25 Milligrams (mg) LY3295668 (Phase 1)	50 mg LY3295668 (Phase 1)	75 mg LY3295668 (Phase 1)	25 mg LY3295668 (Phase 2)	Total
Canada	8	2	2	1	13

Study locations

3 sites

Cross Cancer Institute
Edmonton, Alberta T6G 1Z2, Canada
Jewish General Hospital
Montreal, Quebec H3T 1E2, Canada
McGill University
Montreal, Quebec H4A 3J1, Canada

References and documents

Publications

Chu QS, Bouganim N, Fortier C, Zaknoen S, Stille JR, Kremer JD, Yuen E, Hui YH, de la Pena A, Lithio A, Smith PS, Batist G. Aurora kinase A inhibitor, LY3295668 erbumine: a phase 1 monotherapy safety study in patients with locally advanced or metastatic solid tumors. Invest New Drugs. 2021 Aug;39(4):1001-1010. doi: 10.1007/s10637-020-01049-3. Epub 2021 Jan 22. PubMed 33479856 ↗

Study documents

Study protocol · Apr 10, 2018
Statistical analysis plan · Feb 6, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap, Csr

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03092934
Lead sponsor: Eli Lilly and Company
Collaborators: AurKa Pharma Inc.
Responsible party: Sponsor
First posted: Mar 28, 2017
Start date: May 29, 2017
Primary completion: Apr 20, 2020
Completion: Apr 20, 2020
Results posted: Jul 2, 2021
Last update: Jul 2, 2021

Study contacts

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)

study director · Eli Lilly and Company

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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

Study summary

Conditions studied

Browse trials for

In context

Neoplasms

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Study documents

Individual participant data

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria