NeoplasmPhase 1NCT02377752

A Study of Olaratumab in Japanese Participants With Advanced Cancer

A Phase 1 study testing Olaratumab and Doxorubicin in people with Neoplasm, run by Eli Lilly and Company at 4 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study consists of 2 parts (Part A and Part B). The main purpose of Part A is to evaluate safety and side effects of olaratumab in combination with doxorubicin in Japanese participants with a group of rare cancers (advanced solid tumors, especially advanced soft tissue sarcoma [STS].) The main purpose of Part B is… Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Neoplasm
What is being tested?: Olaratumab and Doxorubicin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 4 sitesJapan
Study dates: 23 Mar 2015to 14 Jan 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Part A: Have histological or cytological evidence of a diagnosis of advanced or metastatic solid tumor, especially STS, which is not amenable to treatment with surgery or radiotherapy. Part B: Have histological or cytological evidence of a diagnosis of solid tumor that is advanced or metastatic.
Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
Have given written informed consent prior to any study-specific procedures.
Have adequate organ and coagulation function
Have an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of less than or equal to 1.
Have discontinued previous treatments for cancer and recovered from the acute effects of therapy.

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(Part A only) Have a prestudy echocardiogram with an actual left ventricular ejection fraction greater than or equal to 50%, within 21 days prior to first dose of study medication.
All participants agree to use a reliable method of birth control and to not donate sperm during the study and for at least 3 months following last dose of study drug.
Female participants:
must either be women not of child-bearing potential due to surgical sterilization confirmed by medical history, or menopause or
women of child-bearing potential who test negative for pregnancy within 7 days before the first dose of study drug based on serum or urine pregnancy test and agree not to breast feed during the study and for 3 months following the last dose of the study drug(s)
Have an estimated life expectancy of more than or equal to 3 months in the judgment of the investigator.

Who cannot join

Have received treatment within 21 days of the initial dose of study drug with an investigational product or non-approved use of a drug or device for non-cancer indications or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
(Part A only) Have received prior treatment with doxorubicin, daunorubicin, idarubicin, and/or other anthracyclines and anthracenediones
(Part A only) Have received prior radiation therapy to the mediastinal/pericardial area.
Have symptomatic central nervous system malignancy or metastasis. Participants with treated central nervous system (CNS) metastases are eligible for this study if they are not currently receiving corticosteroids and/or anticonvulsants, and their disease is asymptomatic and radiographically stable for at least 60 days.
Have an elective or a planned major surgery to be performed during the course of the study.
Have an uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure greater than class II of the New York Heart Association guideline, severe myocardial insufficiency, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

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Have unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction 6 months prior to study entry.
Have a known allergy to any of the treatment components.
Have a history of allergic reactions attributed to compounds of chemical or biologic composition similar to that of olaratumab.
Have a known active fungal, bacterial, and/or known viral infection
Have a corrected QT interval of greater than 470 milliseconds (msec) on screening electrocardiogram (ECG)
Have a second primary malignancy that, in the judgment of the investigator and sponsor, may affect the interpretation of results.

Trial locations and contacts

4 sites in 1 country.

Japan4 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician.
Chūōku, 104-0045
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician.
Kōtoku, 135-8550
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician.
Nagoya, 466-8560
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician.
Suita-shi, 565-0871

Other trials in Japan

About this study

Official title: A Phase 1 Study of Olaratumab in Japanese Patients With Advanced Soft Tissue Sarcoma or Advanced Solid Tumors

Conditions: Neoplasm
Being tested: Olaratumab, Doxorubicin
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OlaratumabBiological
Also called LY3012207, IMC-3G3
Administered IV
DoxorubicinDrug
Administered IV

Study groups in NCT02377752
Study group	Role	What they receive
Part A cohort 1: Olaratumab+Doxorubicin	Experimental	15 milligram per kilogram (mg/kg) of olaratumab administered intravenously (IV) on Day 1 and Day 8, and 25 milligram per square meter (mg/m2) of doxorubicin administered IV on Day 1, Day 2, and Day 3 every 21-day cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met . Receives: Biological: Olaratumab; Drug: Doxorubicin
Part A cohort 2: Olaratumab+Doxorubicin	Experimental	15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 75 mg/m2 of doxorubicin administered IV on Day 1 every 21 day-cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. Receives: Biological: Olaratumab; Drug: Doxorubicin
Part A cohort 3 Olaratumab + Doxorubicin	Experimental	20 mg/kg loading dose of olaratumab administered IV on Day 1 and Day 8 in Cycle 1, followed by 15 mg/kg IV on Day 1 and Day 8 in subsequent cycles, and 75 mg/m2 of doxorubicin administered IV on Day 1 of every 21 day-cycle up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. Receives: Biological: Olaratumab; Drug: Doxorubicin
Part B: Olaratumab	Experimental	15 mg/kg olaratumab administered IV on Day 1 and Day 8 of every 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met. Receives: Biological: Olaratumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Part A: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Clinically significant events were defined as serious adverse events (SAE). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Measured: Baseline to Study completion (Up To 3.5 Years)
Part A: Number of Participants With Dose Limiting Toxicities (DLTs)
DLT is defined as adverse event (AE) during Cycle 1 (Days 1 through 21) that was possibly related to the study drug and toxicities considered by the investigator as dose limiting. A summary of other nonserious AEs, and all serious adverse events (SAE's), regardless of causality, is located in the Reported Adverse Events section.
Measured: Cycle 1 (21 Days)
Part B: Pharmacokinetics: Maximum Observed Concentration (Cmax) of Olaratumab
Maximum observed serum concentration (Cmax) of olaratumab is reported.
Measured: Cycle (C) 1 Day (D) 1 and C3 D1: Pre-infusion, Immediately postinfusion and 1, 24, 48, 72 and 168 hours (h) postinfusion; C1 D8 and C3 D8: Pre- infusion, Immediately postinfusion and 1, 48, 72, 168 and 336 h postinfusion
Part B: Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of Olaratumab
AUC(0-t) hours (h), area under the serum concentration versus time curve from time zero to t hours at AUC(0-168h) for Cycle 1 Day 1 and Cycle 3 Day 1, AUC(0-336h) for Cycle 1 Day 8 and Cycle 3 Day 8 of Olaratumab is reported.
Measured: Cycle (C) 1 Day (D) 1 and C3 D1: Pre-infusion, Immediately postinfusion and 1, 24, 48, 72 and 168 hours (h) postinfusion; C1 D8 and C3 D8: Pre- infusion, Immediately postinfusion and 1, 48, 72, 168 and 336 h postinfusion

Secondary outcomes (6)

Part A: Pharmacokinetics: Maximum Observed Concentration (Cmax) of Olaratumab
Maximum observed serum concentration (Cmax) of olaratumab is reported.
Measured: Cycle (C) 1 Day (D) 1 and C3 D1: Pre-infusion, Immediately postinfusion and 1.5, 24, 48, 72 and 168 hours (h) postinfusion; C1 D8 and C3 D8: Pre- infusion, Immediately postinfusion and 1, 48, 72, 168 and 336 h postinfusion
Part A: Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of Olaratumab
AUC(0-t) hours (h), area under the serum concentration versus time curve from time zero to t hours at AUC(0-168h) for Cycle 1 Day 1 and Cycle 3 Day 1, AUC(0-336h) for Cycle 1 Day 8 and Cycle 3 Day 8 of Olaratumab is reported.
Measured: Cycle (C) 1 Day (D) 1 and C3 D1: Pre-infusion, Immediately postinfusion and 1.5, 24, 48, 72 and 168 hours (h) postinfusion; C1 D8 and C3 D8: Pre- infusion, Immediately postinfusion and 1, 48, 72, 168 and 336 h postinfusion
Part A: Pharmacokinetics: Maximum Observed Concentration (Cmax) of Doxorubicin
Maximum observed plasma concentration (Cmax) of doxorubicin is reported.
Measured: Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3, Cycle 3 Day 1, Cycle 3 Day 2 and Cycle 3 Day 3: Immediately postinfusion
Part A: Pharmacokinetics: Maximum Observed Concentration (Cmax) of Doxorubicin
Maximum observed plasma concentration (Cmax) of doxorubicin is reported.
Measured: Cycle 1 Day 1 and Cycle 3 Day 1: Immediately postinfusion, 0.5, 1, 2, 4, 8, 24, 48, and 72 h postinfusion
Part A: Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of Doxorubicin
Area under the concentration verses time curve from zero to infinity (AUC[0-∞]) of doxorubicin is reported.
Measured: Cycle 1 Day 1 and Cycle 3 Day 1: Immediately postinfusion, 0.5, 1, 2, 4, 8, 24, 48, and 72 h postinfusion
Change From Baseline in Percentage of Participants With a Tumor Response
Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1. Complete Response (CR) is disappearance of all target lesions; Partial Response (PR) is greater than or equal to (≥) 30% decrease in sum of longest diameter of target lesions.
Measured: Baseline to Study completion (Up To 3.5 Years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Mar 201514 Jan 2020

First posted4 Mar 2015 (estimated)
Study start23 Mar 2015
Primary completion27 Aug 2018
Study completion14 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for NeoplasmStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02377752
Sponsor's protocol ID: 15678
Other IDs: I5B-JE-JGDK
Status last verified: Feb 2020
First submitted: 26 Feb 2015
Last updated: 17 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study of Olaratumab in Japanese Patients With Advanced Soft Tissue Sarcoma or Advanced Solid Tumors
ClinicalTrials.gov ID: NCT02377752
Acronym / sponsor ID: 15678
Conditions: Neoplasm
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 23 Mar 2015 (actual)
Primary completion: 27 Aug 2018 (actual)
Study completion: 14 Jan 2020 (actual)
First posted: 4 Mar 2015 (estimated)
Results: Posted 17 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Part A cohort 1: Olaratumab+Doxorubicin	Experimental	Biological: Olaratumab, Drug: Doxorubicin15 milligram per kilogram (mg/kg) of olaratumab administered intravenously (IV) on Day 1 and Day 8, and 25 milligram per square meter (mg/m2) of doxorubicin administered IV on Day 1, Day 2, and Day 3 every 21-day cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met .
Part A cohort 2: Olaratumab+Doxorubicin	Experimental	Biological: Olaratumab, Drug: Doxorubicin15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 75 mg/m2 of doxorubicin administered IV on Day 1 every 21 day-cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met.
Part A cohort 3 Olaratumab + Doxorubicin	Experimental	Biological: Olaratumab, Drug: Doxorubicin20 mg/kg loading dose of olaratumab administered IV on Day 1 and Day 8 in Cycle 1, followed by 15 mg/kg IV on Day 1 and Day 8 in subsequent cycles, and 75 mg/m2 of doxorubicin administered IV on Day 1 of every 21 day-cycle up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met.
Part B: Olaratumab	Experimental	Biological: Olaratumab15 mg/kg olaratumab administered IV on Day 1 and Day 8 of every 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Part A: Have histological or cytological evidence of a diagnosis of advanced or metastatic solid tumor, especially STS, which is not amenable to treatment with surgery or radiotherapy. Part B: Have histological or cytological evidence of a diagnosis of solid tumor that is advanced or metastatic.
Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
Have given written informed consent prior to any study-specific procedures.
Have adequate organ and coagulation function
Have an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of less than or equal to 1.

Key exclusion criteria (12 listed)

Have received treatment within 21 days of the initial dose of study drug with an investigational product or non-approved use of a drug or device for non-cancer indications or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
(Part A only) Have received prior treatment with doxorubicin, daunorubicin, idarubicin, and/or other anthracyclines and anthracenediones
(Part A only) Have received prior radiation therapy to the mediastinal/pericardial area.
Have symptomatic central nervous system malignancy or metastasis. Participants with treated central nervous system (CNS) metastases are eligible for this study if they are not currently receiving corticosteroids and/or anticonvulsants, and their disease is asymptomatic and radiographically stable for at least 60 days.
Have an elective or a planned major surgery to be performed during the course of the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OlaratumabAlso: LY3012207, IMC-3G3Administered IV	Biological	Part A cohort 1: Olaratumab+Doxorubicin, Part A cohort 2: Olaratumab+Doxorubicin, Part A cohort 3 Olaratumab + Doxorubicin, Part B: Olaratumab
DoxorubicinAdministered IV	Drug	Part A cohort 1: Olaratumab+Doxorubicin, Part A cohort 2: Olaratumab+Doxorubicin, Part A cohort 3 Olaratumab + Doxorubicin

Primary outcome

Part A: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline to Study completion (Up To 3.5 Years)
Clinically significant events were defined as serious adverse events (SAE). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Part A: Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Cycle 1 (21 Days)
DLT is defined as adverse event (AE) during Cycle 1 (Days 1 through 21) that was possibly related to the study drug and toxicities considered by the investigator as dose limiting. A summary of other nonserious AEs, and all serious adverse events (SAE's), regardless of causality, is located in the Reported Adverse Events section.
Part B: Pharmacokinetics: Maximum Observed Concentration (Cmax) of Olaratumab
Time frame: Cycle (C) 1 Day (D) 1 and C3 D1: Pre-infusion, Immediately postinfusion and 1, 24, 48, 72 and 168 hours (h) postinfusion; C1 D8 and C3 D8: Pre- infusion, Immediately postinfusion and 1, 48, 72, 168 and 336 h postinfusion
Maximum observed serum concentration (Cmax) of olaratumab is reported.
Part B: Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of Olaratumab
Time frame: Cycle (C) 1 Day (D) 1 and C3 D1: Pre-infusion, Immediately postinfusion and 1, 24, 48, 72 and 168 hours (h) postinfusion; C1 D8 and C3 D8: Pre- infusion, Immediately postinfusion and 1, 48, 72, 168 and 336 h postinfusion
AUC(0-t) hours (h), area under the serum concentration versus time curve from time zero to t hours at AUC(0-168h) for Cycle 1 Day 1 and Cycle 3 Day 1, AUC(0-336h) for Cycle 1 Day 8 and Cycle 3 Day 8 of Olaratumab is reported.

6 secondary outcomes

Part A: Pharmacokinetics: Maximum Observed Concentration (Cmax) of Olaratumab
Time frame: Cycle (C) 1 Day (D) 1 and C3 D1: Pre-infusion, Immediately postinfusion and 1.5, 24, 48, 72 and 168 hours (h) postinfusion; C1 D8 and C3 D8: Pre- infusion, Immediately postinfusion and 1, 48, 72, 168 and 336 h postinfusion
Part A: Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of Olaratumab
Time frame: Cycle (C) 1 Day (D) 1 and C3 D1: Pre-infusion, Immediately postinfusion and 1.5, 24, 48, 72 and 168 hours (h) postinfusion; C1 D8 and C3 D8: Pre- infusion, Immediately postinfusion and 1, 48, 72, 168 and 336 h postinfusion
Part A: Pharmacokinetics: Maximum Observed Concentration (Cmax) of Doxorubicin
Time frame: Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3, Cycle 3 Day 1, Cycle 3 Day 2 and Cycle 3 Day 3: Immediately postinfusion
Part A: Pharmacokinetics: Maximum Observed Concentration (Cmax) of Doxorubicin
Time frame: Cycle 1 Day 1 and Cycle 3 Day 1: Immediately postinfusion, 0.5, 1, 2, 4, 8, 24, 48, and 72 h postinfusion
Part A: Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of Doxorubicin
Time frame: Cycle 1 Day 1 and Cycle 3 Day 1: Immediately postinfusion, 0.5, 1, 2, 4, 8, 24, 48, and 72 h postinfusion
Change From Baseline in Percentage of Participants With a Tumor Response
Time frame: Baseline to Study completion (Up To 3.5 Years)

Results and safety

Results posted to the registry on 17 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A Cohort 1: Olaratumab+Doxorubicin	7	7
Part A Cohort 2: Olaratumab+Doxorubicin	6	6
Part A Cohort 3 Olaratumab + Doxorubicin	6	6
Part B: Olaratumab	6	6

Primary outcome: Part A: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Time frame: Baseline to Study completion (Up To 3.5 Years). Number. Unit: participants

Measure	Part A Cohort 1: Olaratumab+Doxorubicin n = 7	Part A Cohort 2: Olaratumab+Doxorubicin n = 6	Part A Cohort 3 Olaratumab + Doxorubicin n = 6
Value	1	4	1

Population analysed: All enrolled participants who received any amount of study drugs (either olaratumab or doxorubicin) in Part A.

Primary outcome: Part A: Number of Participants With Dose Limiting Toxicities (DLTs)

Time frame: Cycle 1 (21 Days). Count of participants. Unit: Participants

Measure	Part A Cohort 1: Olaratumab+Doxorubicin n = 7	Part A Cohort 2: Olaratumab+Doxorubicin n = 6	Part A Cohort 3 Olaratumab + Doxorubicin n = 6
Value	0	1	0

Population analysed: All enrolled patients who completed Cycle 1 (initial 21-day treatment period), or who discontinued due to DLT during Cycle 1 in Part A.

Primary outcome: Part B: Pharmacokinetics: Maximum Observed Concentration (Cmax) of Olaratumab

Time frame: Cycle (C) 1 Day (D) 1 and C3 D1: Pre-infusion, Immediately postinfusion and 1, 24, 48, 72 and 168 hours (h) postinfusion; C1 D8 and C3 D8: Pre- infusion, Immediately postinfusion and 1, 48, 72, 168 and 336 h postinfusion. Geometric mean (Geometric Coefficient of Variation). Unit: microgram per milliliter (μg/mL)

Measure	Part B: Olaratumab n = 6
Cycle 1 Day 1	322 (22)
Cycle 1 Day 8	409 (32)
Cycle 3 Day 1	396 (16)
Cycle 3 Day 8	478 (15)

Population analysed: All enrolled participants who received any amount of study drug (olaratumab) and had evaluable pharmacokinetics (PK) data in Part B.

Primary outcome: Part B: Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of Olaratumab

Measure	Part B: Olaratumab n = 6
Cycle 1 Day 1: AUC(0-168h)	23300 (26)
Cycle 1 Day 8: AUC(0-336h)	48100 (47)
Cycle 3 Day 1: AUC(0-168h)	39800 (14)
Cycle 3 Day 8: AUC(0-336h)	NA (NA)

Population analysed: All enrolled participants who received any amount of study drug (olaratumab) and had evaluable PK data in Part B.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to Study completion (Up To 3.5 Years). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A Cohort 1: Olaratumab+Doxorubicin	1 of 7 (14.3%)	7 of 7 (100%)	0 of 7
Part A Cohort 2: Olaratumab+Doxorubicin	4 of 6 (66.7%)	6 of 6 (100%)	0 of 6
Part A Cohort 3 Olaratumab + Doxorubicin	1 of 6 (16.7%)	6 of 6 (100%)	0 of 6
Part B: Olaratumab	2 of 6 (33.3%)	5 of 6 (83.3%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST) study director

Eli Lilly and Company

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Olaratumab and Doxorubicin in people with Neoplasm, run by Eli Lilly and Company at 4 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline to Study completion (Up To 3.5 Years)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02377752.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.