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Sarcoma, Soft TissuePhase 1/2NCT01185964

A Study of Olaratumab in Soft Tissue Sarcoma

A Phase 1/2 study testing Olaratumab and doxorubicin in people with Sarcoma, Soft Tissue, run by Eli Lilly and Company at 17 sites in United States.

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

The main purpose of this study is to gather information about the use of an investigational drug called olaratumab with a drug for soft tissue sarcoma called doxorubicin. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma, Soft Tissue
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
148 participants
Where
17 sitesUnited States
Study dates
Oct 2010to Apr 2016
Phase
Phase 1/2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The participant has histologically- or cytologically-confirmed malignant soft tissue sarcoma
  • The participant has advanced soft tissue sarcoma (STS), not amenable to treatment with surgery or radiotherapy
  • The participant's Eastern Cooperative Oncology Group (ECOG) performance status is 0-2
  • The participant has available tumor tissue from either the primary or metastatic tumor for determination of PDGFRα expression
  • The participant has adequate hematologic function as defined by an absolute neutrophil count (ANC) ≥ 1500 μL, hemoglobin ≥ 9.0 g/dL, and a platelet count of 100,000/μL obtained within 2 weeks prior to study entry
  • The participant has adequate hepatic function as defined by a total bilirubin ≤ 1.5 mg/dL, and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 times the upper limit of normal (ULN)
  • The participant has adequate renal function as defined by serum creatinine ≤ 1.5 × the institutional ULN. If creatinine is above the ULN, the participant's creatinine clearance is ≥ 45 mL/min
  • Because the teratogenicity of Olaratumab is not known, women of childbearing potential (WOCBP) and sexually active males must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation

Who cannot join

  • The participant has histologically- or cytologically-confirmed Kaposi's sarcoma
  • The participant has untreated central nervous system metastases
  • The participant received prior treatment with doxorubicin, daunorubicin, idarubicin, and/or other anthracyclines and anthracenediones (ie, mitoxantrone)
  • The participant received prior radiation therapy to the mediastinal/pericardial area
  • The participant has a history of another primary cancer, with the exception of a) curatively resected nonmelanomatous skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor treated with curative intent, no known active disease present, and no treatment administered during the last 3 years prior to study entry
  • The participant is receiving concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemo-embolization, targeted therapy, or an investigational agent
Show all 12Show fewer
  • The participant has an elective or a planned major surgery to be performed during the course of the study
  • The participant has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, requiring parenteral antibiotics, symptomatic congestive heart failure, severe myocardial insufficiency, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • The participant has unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction 6 months prior to study entry
  • The participant has known immunodeficiency virus (HIV) infection
  • The participant, if female, is pregnant or lactating
  • The participant has a known allergy to any of the treatment components

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • ImClone Investigational Site

    Atlanta, Georgia, 30308

  • ImClone Investigational Site

    Aurora, Colorado, 80045

  • ImClone Investigational Site

    Charleston, South Carolina, 29425

  • ImClone Investigational Site

    Charlotte, North Carolina, 28203

  • ImClone Investigational Site

    Chicago, Illinois, 60611

  • ImClone Investigational Site

    Cleveland, Ohio, 44106

  • ImClone Investigational Site

    Gainesville, Florida, 32608

  • ImClone Investigational Site

    Los Angeles, California, 90024

  • ImClone Investigational Site

    Madison, Wisconsin, 53792

  • ImClone Investigational Site

    Memphis, Tennessee, 38119

  • ImClone Investigational Site

    New York, New York, 10065

  • ImClone Investigational Site

    Orlando, Florida, 32806

  • ImClone Investigational Site

    Rochester, Minnesota, 55902

  • ImClone Investigational Site

    San Antonio, Texas, 78229

  • ImClone Investigational Site

    Seattle, Washington, 98109

  • ImClone Investigational Site

    St Louis, Missouri, 63110

  • ImClone Investigational Site

    Tucson, Arizona, 85724

Other trials in United States

About this study

Official title: A Phase 1b/2, With Phase 2 Randomized, Study Evaluating the Efficacy of Doxorubicin With or Without a Human Anti-PDGFRα Monoclonal Antibody (IMC-3G3) in the Treatment of Advanced Soft Tissue Sarcoma

The main purpose of this study is to gather information about the use of an investigational drug called olaratumab with a drug for soft tissue sarcoma called doxorubicin.

Being tested
Olaratumab, doxorubicin
Keywords
Sarcoma, Soft Tissue, Advanced Soft Tissue Sarcoma
Medical subject headings
Sarcoma

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

    Olaratumab 15 mg/kg by intravenous transfusion (I.V.) on days 1+8 of a 21-day cycle

  • doxorubicinDrug

    Doxorubicin 75 mg/m2 by intravenous injection on day 1 of the 21-day cycle.

Study groups in NCT01185964
Study groupRoleWhat they receive
Phase 1b: Olaratumab + doxorubicinExperimentalAll cycles are 21 days. Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1 All subsequent cycles until progression: Olaratumab 15 mg/kg on days 1+8
Receives: Biological: Olaratumab; Drug: doxorubicin
Phase 2: Olaratumab and doxorubicinExperimentalAll cycles are 21 days. Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1 All subsequent cycles until progression: Olaratumab 15 mg/kg on days 1+8
Receives: Biological: Olaratumab; Drug: doxorubicin
Phase 2: Doxorubicin: Optional Olaratumab After ProgressionActive comparatorAll cycles are 21 days. Cycles 1-8: doxorubicin 75 mg/m2 on day 1 until disease progression. At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression.
Receives: Drug: doxorubicin

What is being measured

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

  1. Progression-free Survival (PFS)

    PFS is measured from randomization until the first radiographic documentation of progression of disease (PD) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) or death from any cause. Participants who died without PD was considered to have progressed on the day of death. The following censoring rules applied: If no radiologic assessment at baseline or post baseline, participant was censored at the date of randomization. Participants were censored at the day of their last tumor assessment if no PD and were lost to follow up; If death or PD occurred after 2 or more consecutive missing radiographic visits, censoring occurred at the date of the last adequate radiographic visit. If participant started new treatment before PD, the participant was censored at the date of last tumor assessment prior to new therapy. If treatment was discontinued for reasons other than PD and no further assessment, censoring occurred at last tumor assessment.

    Measured: Randomization Until the First Radiographic Documentation of Objective Progression (Up to 29 Months)

  2. Number of Participants With Treatment Related Adverse Events (TEAE), Adverse Events (AE) or Serious Adverse Events (SAE) for Safety for the Phase 1b Portion of the Study

    All Phase 1b participants who experienced at least 1 TEAE in the Phase 1b portion of the study. Adverse Event with missing relationship to study is counted as related. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.

    Measured: Baseline Up to 30 Months

Secondary outcomes (9)

  1. Number of Participants With AEs and SAEs for Phase 2 Portion

    A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.

    Measured: Baseline, Up to 30 Months

  2. Overall Survival (OS)

    OS was defined as the date of randomization to the date of death from any cause. Reasons for censoring OS were that participant was known to be alive, participant was lost to follow up during the study or participant withdrew consent to follow up.

    Measured: Randomization to the Date of Death From Any Cause (Up To 47 Months)

  3. Percentage of Participants With Objective Response (Objective Response Rate)

    Objective Response Rate (ORR) is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; CR was defined as the disappearance of all target and non-target lesions. Percentage of participants was calculated as: total number of participants with a best tumor response of PR or CR among participants counted in the denominator/total number of participants treated with any amount of study drug, who has a complete radiographic assessment at baseline, and who has at least 1 complete radiographic assessment at postbaseline x 100%.

    Measured: Randomization Until Progressive Disease (Up to 30 Months)

  4. Percentage of Participants Who Are Progression-Free (PFS) at 3 Months

    (PFS) rate is defined as the percentage of participants that are alive and progression-free 3 months after randomization. PFS is measured from randomization until the first radiographic progressive disease as defined by RECIST (version 1.1) or death from any cause. Participants who died without PD were considered to have progressed on the day of death. Censoring applied: If no radiologic assessment at baseline or post baseline, participant was censored at the date of randomization or the day of their last tumor assessment if no PD and were lost to follow up; If death or PD occurred after 2 or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit. If participant started new treatment before PD, participant was censored at the date of last tumor assessment prior to new therapy. If treatment was discontinued for reasons other than PD and no further assessment, censoring occurred at last tumor assessment.

    Measured: Randomization Until First Radiographic PD or Death from Any Cause (Up to 3 Months)

  5. Pharmacokinetic (PK) Maximum Concentration (Cmax) Cycle 1 Day 1, Cycle 3 Day 1 of Olaratumab

    Measured: Cycle 1 Day 1: Preinfusion, End of Infusion,1hr,48hr,72hr,168 hr Post infusion; Cycle 3 Day 1:Preinfusion, End of Infusion,1hr,24hr,48hr,72hr,168hr Post Infusion

  6. PK: Minimum Concentration (Cmin) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab

    Measured: Cycle 1 Day 8: Preinfusion, 1hr,72hr,168hr Post Infusion; Cycle 3 Day 8: Preinfusion,1hr, 24hr,72hr,168hr Post Infusion

  7. PK: Area Under Concentration Curve Versus Time (AUCτ) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab

    AUCτ = area under the concentration versus time curve during one dosing interval with a measurable concentration.

    Measured: Cycle 1 Day 8:Preinfusion,1hr,72hr,168hr Post Infusion; Cycle 3 Day 8: Preinfusion,1hr,24hr,72hr,168hr Post Infusion

  8. PK: Half-Life (T1/2) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab

    Measured: Cycle 1 Day 8:Preinfusion,1hr,72hr,168hr Post Infusion; Cycle 3 Day 8: Preinfusion,1hr,24hr,72hr,168hr Post Infusion

  9. Percentage of Participants With Anti-Olaratumab Antibody Assessment

    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: Baseline, Up to 30 Months

Timeline

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

  1. First posted20 Aug 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionAug 2014
  4. Study completionApr 2016

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
148 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01185964
Sponsor's protocol ID
14055
Other IDs
I5B-IE-JGDG, CP15-0806
Status last verified
Mar 2017
First submitted
19 Aug 2010
Last updated
14 Apr 2017
Data monitoring committee
No

Publications

  • Tap WD, Jones RL, Van Tine BA, Chmielowski B, Elias AD, Adkins D, Agulnik M, Cooney MM, Livingston MB, Pennock G, Hameed MR, Shah GD, Qin A, Shahir A, Cronier DM, Ilaria R Jr, Conti I, Cosaert J, Schwartz GK. Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial. Lancet. 2016 Jul 30;388(10043):488-97. doi: 10.1016/S0140-6736(16)30587-6. Epub 2016 Jun 9.

    PubMed 27291997

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Olaratumab and doxorubicin in people with Sarcoma, Soft Tissue, run by Eli Lilly and Company at 17 sites in United States.

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 8 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 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 17 sites in United States. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Progression-free Survival (PFS) (time frame: Randomization Until the First Radiographic Documentation of Objective Progression (Up to 29 Months)). The study lists 2 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 NCT01185964, which also lists 1 linked publication.

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.

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