MalignancyPhase 1NCT01199822

Study of the Safety and Pharmacokinetics of Olaratumab (IMC-3G3) in Japanese Participants With Solid Tumors

A Phase 1 study testing Olaratumab in people with Malignancy and Metastasis, run by Eli Lilly and Company at 1 site 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

Who is it for?: Ages 20 years and older
Conditions the study is for: Malignancy, Metastasis
What is being tested?: Olaratumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteJapan
Study dates: Sep 2010to Jan 2012
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

Solid tumor that has been histopathologically or cytologically documented
Advanced primary or recurrent solid tumor participants who has not responded to standard therapy or for whom no standard therapy is available
Measurable or nonmeasurable lesions
An Eastern Cooperative Oncology Group Performance Status score of 0-1
Able to provide informed consent
Has a life expectancy of >3 months

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Adequate hematologic function
Adequate hepatic function
Has adequate renal function
Agrees to use adequate contraception for the duration of study participation and for at least 12 weeks after the last dose of study therapy
Adequate recovery from recent surgery, chemotherapy, and radiation therapy (including palliative radiation therapy). At least 28 days (6 weeks for nitrosoureas or mitomycin C) must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent or device, or prior radiation therapy. For treatment with non-approved monoclonal antibodies, a minimum of 8 weeks must have elapsed
Is willing to comply with study procedures until the End-of-Therapy visit

Who cannot join

Received chemotherapy or therapeutic radiotherapy within 28 days (6 weeks for nitrosoureas or mitomycin C) prior to entering the study, or has ongoing side effects ≥ Grade 2 due to agents administered more than 28 days earlier
Has undergone major surgery [example (e.g.), laparotomy, thoracotomy, removal of organ(s)] within 28 days prior to study entry
Elective or planned surgery to be conducted during the trial
Documented and/or symptomatic brain or leptomeningeal metastases (participants who are clinically stable [no symptoms during the 4 weeks prior to study entry] with an assessment that no further treatment [radiation, surgical excision, or administration of steroids] is required are permitted to enter the study)
Uncontrolled intercurrent illness including, but not limited to:
Active infection requiring systemic antibiotic treatment excluding oral administration [≥Grade 3 National Cancer Institute - Common Terminology Criteria for Adverse Events [NCI-CTCAE Version (v) 4.02)]

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Congestive heart failure (Class III or IV per the New York Heart Association classification for heart disease)
Angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months
Uncontrolled hypertension [systolic blood pressure >150 millimeters of mercury (mm Hg), diastolic blood pressure >95 mm Hg]
Cardiac arrhythmia requiring treatment (NCI-CTCAE v4.02, or asymptomatic sustained ventricular tachycardia
Peripheral neuropathy of any etiology ≥Grade 2 (NCI-CTCAE v4.02); or
Any other serious uncontrolled medical disorder(s) in the opinion of the investigator
Participated in clinical studies of non-approved experimental agents or procedures within 4 weeks prior to study for small molecules, or 8 weeks prior to study entry for non-approved monoclonal antibodies
Received any previous treatment with agents targeting the platelet-derived growth factor (PDGF) or platelet-derived growth factor receptor (PDGFR), approved or non-approved
Known allergy to any of the treatment components (IMC-3G3, histidine, glycine, sodium chloride, mannitol, or polysorbate)
If female, is pregnant (confirmed by urine or serum pregnancy test) or lactating
Known alcohol or drug dependency
Hepatitis B virus (HBV) antigen-, hepatitis C virus (HCV) antibody-, or human immunodeficiency (HIV) antibody-positive [asymptomatic healthy carriers with detectable HBV-Deoxyribonucleic acid (DNA), HCV-Ribonucleic acid (RNA) may be enrolled into the trial]
Assessed as inadequate for the study by the investigator

Trial locations and contacts

1 site in 1 country.

Japan1 site

ImClone Investigational Site
Kashiwa, Chiba

Other trials in Japan

About this study

Official title: A Phase 1 Study Evaluating the Safety and Pharmacokinetic Profiles of IMC-3G3 Administered in a 2-week, or 3-week Schedule to Japanese Patients With Advanced Solid Tumors

Participants in this single-center, open-label, dose-escalation, Phase 1 study will initially receive intravenous (IV) olaratumab once every 2 weeks or on Days 1 and 8 every 3 weeks for 6 weeks (one cycle). After the first cycle, participants experiencing an overall response of complete response (CR), partial response (PR), or stable disease (SD) will continue to receive olaratumab at their cohort dose and schedule until there is evidence of progressive disease (PD), or until other withdrawal criteria are met.

Conditions: Malignancy, Metastasis
Being tested: Olaratumab
Medical subject headings: Neoplasms, Neoplasm Metastasis

What participants receive

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

OlaratumabBiological
Also called IMC-3G3, LY3012207
Cohort 1 10 milligrams/kilogram (mg/kg) intravenously (IV) administered on Days 1 and 8, every 3 weeks; Cohort 2 20 mg/kg IV administered every 2 weeks; Cohort 3 15 mg/kg IV administered on Days 1 and 8, every 3 weeks

Study groups in NCT01199822
Study group	Role	What they receive
Olaratumab	Experimental	Not described Receives: Biological: Olaratumab

What is being measured

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

Number of Participants With Adverse Events (AEs)
Data presented are the number of participants who experienced AEs of any grade and AEs of Grade ≥3 as determined by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 4.02. A summary of serious adverse events (SAEs) and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Measured: First dose to study completion up to 5.6 months
Number of Participants With SAEs
A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Measured: First dose to study completion up to 5.6 months
Number of Participants With a Dose- Limiting Toxicity (DLT) in Cycle 1
A DLT is defined as 1 of the following events, if considered by the investigator to be definitely, probably, or possibly related to olaratumab: NCI-CTCAE v4.02 Grade 4 neutropenia lasting >7 days; NCI-CTCAE v4.02 Grade ≥3 thrombocytopenia with signs of bleeding or requiring platelet transfusions; NCI-CTCAE v4.02 Grade ≥3 neutropenia associated with fever; NCI-CTCAE v4.02 Grade 3 or 4 nonhematologic toxicity, excluding electrolyte abnormality; NCI-CTCAE v4.02 Grade ≥3 skin toxicity despite best preemptive and supportive care; and/or NCI-CTCAE v4.02 Grade ≥3 diarrhea, nausea, or vomiting despite best preemptive and supportive care.
Measured: First dose through Cycle 1 (6 weeks/cycle)
Maximum Concentration (Cmax) of Olaratumab Following Multiple Doses
Measured: Cycle 2: Pre-dose and up to 336 hours post-dose

Secondary outcomes (6)

Area Under the Concentration of Olaratumab Versus Time Curve During One Dosing Interval (AUCτ) Following Multiple Doses
Measured: Cycle 2: Pre-dose and up to 336 hours post-dose
Terminal Elimination Half-Life (t1/2) of Olaratumab
t1/2 is the time it takes for the drug concentration in serum to decrease to half the value observed at the beginning of the time period.
Measured: Cycle 2: Pre-dose and up to 336 hours post-dose
Clearance of Olaratumab at Steady State (CLss)
CLss is the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time at steady-state.
Measured: Cycle 2: Pre-dose and up to 336 hours post-dose
Volume of Distribution at Steady State (Vss)
Measured: Cycle 2: Pre-dose and up to 336 hours post-dose
Number of Participants With Serum Anti-Olaratumab Antibody Assessment (Immunogenicity)
Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.
Measured: First dose to study completion up to 5.6 months
Number of Participants With Treatment Related AEs
Data presented are the number of participants who experienced a treatment related AE of any grade.
Measured: First dose to study completion up to 5.6 months

Timeline

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

Sep 2010Jan 2012

First posted13 Sep 2010 (estimated)
Study startSep 2010
Primary completionJan 2012
Study completionJan 2012

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 MalignancyStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01199822
Sponsor's protocol ID: 13940
Other IDs: CP15-0907, I5B-IE-JGDF, 21-3720
Status last verified: Mar 2017
First submitted: 8 Sep 2010
Last updated: 14 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study Evaluating the Safety and Pharmacokinetic Profiles of IMC-3G3 Administered in a 2-week, or 3-week Schedule to Japanese Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT01199822
Acronym / sponsor ID: 13940
Conditions: Malignancy, Metastasis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Jan 2012 (actual)
Study completion: Jan 2012 (actual)
First posted: 13 Sep 2010 (estimated)
Results: Posted 14 Apr 2017

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Olaratumab	Experimental	Biological: Olaratumab

Who may qualify

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

Key inclusion criteria (12 listed)

Solid tumor that has been histopathologically or cytologically documented
Advanced primary or recurrent solid tumor participants who has not responded to standard therapy or for whom no standard therapy is available
Measurable or nonmeasurable lesions
An Eastern Cooperative Oncology Group Performance Status score of 0-1
Able to provide informed consent

Key exclusion criteria (19 listed)

Received chemotherapy or therapeutic radiotherapy within 28 days (6 weeks for nitrosoureas or mitomycin C) prior to entering the study, or has ongoing side effects ≥ Grade 2 due to agents administered more than 28 days earlier
Has undergone major surgery [example (e.g.), laparotomy, thoracotomy, removal of organ(s)] within 28 days prior to study entry
Elective or planned surgery to be conducted during the trial
Documented and/or symptomatic brain or leptomeningeal metastases (participants who are clinically stable [no symptoms during the 4 weeks prior to study entry] with an assessment that no further treatment [radiation, surgical excision, or administration of steroids] is required are permitted to enter the study)
Uncontrolled intercurrent illness including, but not limited to:

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: IMC-3G3, LY3012207Cohort 1 10 milligrams/kilogram (mg/kg) intravenously (IV) administered on Days 1 and 8, every 3 weeks; Cohort 2 20 mg/kg IV administered every 2 weeks; Cohort 3 15 mg/kg IV administered on Days 1 and 8, every 3 weeks	Biological	Olaratumab

Primary outcome

Number of Participants With Adverse Events (AEs)
Time frame: First dose to study completion up to 5.6 months
Data presented are the number of participants who experienced AEs of any grade and AEs of Grade ≥3 as determined by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 4.02. A summary of serious adverse events (SAEs) and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Number of Participants With SAEs
Time frame: First dose to study completion up to 5.6 months
A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Number of Participants With a Dose- Limiting Toxicity (DLT) in Cycle 1
Time frame: First dose through Cycle 1 (6 weeks/cycle)
A DLT is defined as 1 of the following events, if considered by the investigator to be definitely, probably, or possibly related to olaratumab: NCI-CTCAE v4.02 Grade 4 neutropenia lasting >7 days; NCI-CTCAE v4.02 Grade ≥3 thrombocytopenia with signs of bleeding or requiring platelet transfusions; NCI-CTCAE v4.02 Grade ≥3 neutropenia associated with fever; NCI-CTCAE v4.02 Grade 3 or 4 nonhematologic toxicity, excluding electrolyte abnormality; NCI-CTCAE v4.02 Grade ≥3 skin toxicity despite best preemptive and supportive care; and/or NCI-CTCAE v4.02 Grade ≥3 diarrhea, nausea, or vomiting despite best preemptive and supportive care.
Maximum Concentration (Cmax) of Olaratumab Following Multiple Doses
Time frame: Cycle 2: Pre-dose and up to 336 hours post-dose

6 secondary outcomes

Area Under the Concentration of Olaratumab Versus Time Curve During One Dosing Interval (AUCτ) Following Multiple Doses
Time frame: Cycle 2: Pre-dose and up to 336 hours post-dose
Terminal Elimination Half-Life (t1/2) of Olaratumab
Time frame: Cycle 2: Pre-dose and up to 336 hours post-dose
Clearance of Olaratumab at Steady State (CLss)
Time frame: Cycle 2: Pre-dose and up to 336 hours post-dose
Volume of Distribution at Steady State (Vss)
Time frame: Cycle 2: Pre-dose and up to 336 hours post-dose
Number of Participants With Serum Anti-Olaratumab Antibody Assessment (Immunogenicity)
Time frame: First dose to study completion up to 5.6 months
Number of Participants With Treatment Related AEs
Time frame: First dose to study completion up to 5.6 months

Results and safety

Results posted to the registry on 14 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
10 mg/kg Olaratumab (IMC-3G3)	3	3
20 mg/kg Olaratumab	7	6
15 mg/kg Olaratumab	6	6

Primary outcome: Number of Participants With Adverse Events (AEs)

Time frame: First dose to study completion up to 5.6 months. Number. Unit: participants

Measure	10 mg/kg Olaratumab n = 3	20 mg/kg Olaratumab n = 7	15 mg/kg Olaratumab n = 6
AE of Any Grade	3	7	6
AE of Grade ≥3	1	1	0

Population analysed: All enrolled participants who received at least 1 dose of study drug.

Primary outcome: Number of Participants With SAEs

Time frame: First dose to study completion up to 5.6 months. Number. Unit: participants

Measure	10 mg/kg Olaratumab n = 3	20 mg/kg Olaratumab n = 7	15 mg/kg Olaratumab n = 6
Value	0	1	0

Population analysed: All enrolled participants who received at least 1 dose of study drug.

Primary outcome: Number of Participants With a Dose- Limiting Toxicity (DLT) in Cycle 1

Time frame: First dose through Cycle 1 (6 weeks/cycle). Number. Unit: participants

Measure	10 mg/kg Olaratumab n = 3	20 mg/kg Olaratumab n = 7	15 mg/kg Olaratumab n = 6
Value	0	0	0

Population analysed: All enrolled participants who received at least 1 dose of study drug.

Primary outcome: Maximum Concentration (Cmax) of Olaratumab Following Multiple Doses

Time frame: Cycle 2: Pre-dose and up to 336 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: micrograms/milliliter (µg/mL)

Measure	10 mg/kg Olaratumab n = 2	20 mg/kg Olaratumab n = 3	15 mg/kg Olaratumab n = 1
Value	603 (NA)	1160 (91)	921 (NA)

Population analysed: All participants who received study drug and had pharmacokinetic (PK) data available to calculate Cmax. Due to the limited data, Cmax is not representative of the study population.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
10 mg/kg Olaratumab	0 of 3 (0%)	3 of 3 (100%)	Not reported
20 mg/kg Olaratumab	1 of 7 (14.3%)	7 of 7 (100%)	Not reported
15 mg/kg Olaratumab	0 of 6 (0%)	6 of 6 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

1 site 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 in people with Malignancy and Metastasis, run by Eli Lilly and Company at 1 site 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 19 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 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 14 Apr 2017). 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?

Number of Participants With Adverse Events (AEs) (time frame: First dose to study completion up to 5.6 months). 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 NCT01199822.

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 14 Apr 2017.