Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02536586
Other study ID # 15838
Secondary ID I6A-JE-CBBH
Status Completed
Phase Phase 1
First received
Last updated
Start date September 2015
Est. completion date February 9, 2017

Study information

Verified date July 2018
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate the tolerability of an investigational drug known as LY3023414 in Japanese participants with advanced cancer or cancer that has spread to another part(s) of the body. The study will also explore the safety of the drug. It will measure how much of the drug gets into the blood steam and how long the body takes to get rid of it. It will investigate anti-cancer activity.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date February 9, 2017
Est. primary completion date February 9, 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria

- Have histological or cytological evidence of a diagnosis of solid tumor that is advanced and/or metastatic and must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed or for whom standard therapy would not be appropriate.

- Have the presence of measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

- Have adequate organ and coagulation function.

- Have discontinued all previous cancer therapies, and any agents that have not received regulatory approval for any indication, for at least 21 days or 5 half-lives prior to study treatment, whichever is shorter, and recovered from the acute effects of therapy. Participants must have discontinued mitomycin-C or nitrosourea therapy for at least 42 days.

- Are able to swallow capsules.

- Males must agree to use medically approved barrier contraceptive precautions during the study and for 3 months following the last dose of study drug.

- Females with childbearing potential: Must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug, must have had a negative serum or urine pregnancy test =7 days before the first dose of study drug.

- A breastfeeding woman must not be breastfeeding. If a female who stops breastfeeding enters the study, breastfeeding must cease from the day of the first study drug administration until at least 3 months after the last administration.

Exclusion Criteria

- Have serious pre-existing medical conditions.

- Have symptomatic central nervous system malignancy or metastasis.

- Have known acute or chronic leukemia or current hematologic malignancies that, in the judgment of the investigator and sponsor, may affect the interpretation of results.

- Have a known active fungal, bacterial, and/or known viral infection.

- Intolerance to any previous treatment with any phosphatidylinositol 3-kinase (PI3K)/AKT/mammalian target of rapamycin (mTOR) inhibitor. Treatment with any PI3K/AKT/mTOR inhibitor must have discontinued for at least 21 days or 5 half-lives prior to first study drug administration, whichever is shorter, and participants must have recovered from the acute effects of therapy.

- Have a second primary malignancy that, in the judgment of the investigator, and sponsor may affect the interpretation of results.

- Participants with active alcohol abuse, as determined by the investigator.

- Have a history of heart failure according to New York Heart Association Class =3.

- Have corrected QT (QTc) interval of >470 milliseconds (msec) on screening electrocardiogram (ECG).

- Have insulin-dependent diabetes mellitus or a history of gestational diabetes mellitus.

- Have any evidence of clinically active interstitial lung disease (ILD).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
LY3023414
LY3023414 administered orally.

Locations

Country Name City State
Japan For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. Chiba
Japan For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. Tokyo

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with LY3023414 Dose-Limiting Toxicities (DLT) Cycle 1 (21 days)
Secondary Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve (AUC) of LY3023414 Predose Cycle 1 through predose Cycle 3. (Cycle = 21 days.)
Secondary Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3023414 Predose Cycle 1 through predose Cycle 3. (Cycle = 21 days.)
Secondary Proportion of Participants With Best Overall Response (OR) of Partial Response (PR) or Complete Response (CR) (Overall Response Rate [ORR]) Baseline through study completion (estimated as up to five months)
See also
  Status Clinical Trial Phase
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Completed NCT00199836 - A Pilot Study of NY-ESO-1b Peptide Plus CpG 7909 and Montanide® ISA-51 in Patients With Cancer. Phase 1
Completed NCT01672944 - Evaluating Biobanking Educational Tools N/A
Not yet recruiting NCT02226289 - Bevacizumab-containing Regimen for Metastatic Colorectal Cancer Failed to Cytotoxic Treatment Phase 2
Completed NCT02746185 - Cancer Associated Thrombosis, a Pilot Treatment Study Using Rivaroxaban Phase 3
Completed NCT02759640 - A Phase I Trial of HS-10241 in Solid Tumors Phase 1
Completed NCT02747342 - A Phase 1 Trial of SHR3680 With or Without SHR3162 in Prostate Cancer Phase 1
Completed NCT02309164 - The Use of Acupuncture for Treatment of Chemotherapy-induced Peripheral Neuropathy (CIPN). N/A
Completed NCT02394821 - Odor Management in Fungating Wounds Comparing Metronidazole and Polihexanide Phase 3
Completed NCT01457196 - Development of a Tumor Molecular Analyses Program and Its Use to Support Treatment Decisions N/A
Completed NCT00143533 - Prevention of Diarrhea in Patients Taking IV Irinotecan for Relapsed or Difficult to Treat Pediatric Solid Tumors Phase 1
Recruiting NCT05450562 - Dose Escalation and Expansion Study of SAR444200-based Regimen in Adult Participants With Advanced Solid Tumors Phase 1/Phase 2
Completed NCT00001835 - Oxaliplatin in Cancer Patients With Impaired Kidney Function Phase 1
Completed NCT00001341 - A Phase I Trial of ZD1694 (TOMUDEX), an Inhibitor of Thymidylate Synthase, in Pediatric Patients With Advanced Neoplastic Disease Phase 1
Completed NCT01425008 - Study of MLN2480 in Participants With Relapsed or Refractory Solid Tumors Followed by a Dose Expansion in Participants With Metastatic Melanoma Phase 1
Recruiting NCT05101798 - The Role of 5-Aminolevulinic Acid Fluorescence-Guided Surgery in Head and Neck Cancers: a Pilot Trial Phase 2
Completed NCT01920061 - A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents and in Combination With Cisplatin in Patients With Triple Negative Breast Cancer in an Expansion Arm (TNBC) Phase 1
Terminated NCT03251924 - A Dose Escalation and Combination Immunotherapy Study to Evaluate BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT02851706 - Natural History of and Specimen Banking for People With Tumors of the Central Nervous System
Terminated NCT05429762 - Effect of Tusamitamab Ravtansine on QTc Interval in Participants With Metastatic Solid Tumors Phase 1