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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02451943




Registration number
NCT02451943
Ethics application status
Date submitted
20/05/2015
Date registered
22/05/2015
Date last updated
14/07/2020

Titles & IDs
Public title
A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Doxorubicin Plus Olaratumab Versus Doxorubicin Plus Placebo in Patients With Advanced or Metastatic Soft Tissue Sarcoma
Secondary ID [1] 0 0
I5B-MC-JGDJ
Secondary ID [2] 0 0
15677
Universal Trial Number (UTN)
Trial acronym
ANNOUNCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Soft Tissue Sarcoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Olaratumab
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Placebo

Experimental: Doxorubicin + Olaratumab - 75 milligrams per meter squared (mg/m^2) doxorubicin administered intravenously (IV) on day 1 of each 21-day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21-day cycle until documented progressive disease (PD) or discontinuation for any other reason.

Placebo Comparator: Doxorubicin + Placebo - 75 mg/m^2 doxorubicin administered IV on day 1 of each 21-day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21-day cycle until PD or discontinuation for any other reason.


Treatment: Drugs: Olaratumab
Administered IV

Treatment: Drugs: Doxorubicin
Administered IV

Treatment: Drugs: Placebo
Administered IV

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) - Overall survival was defined as the time from the date of randomization to the date of death due to any cause. For each participant, prior to data analysis, a reasonable effort was made to obtain the most up-to-date status (date of death or last date known to be alive). For any participant not known to have died as of the data cutoff date, OS was censored at the date the participant was last known to be alive. For any participant who withdrew consent for survival follow-up, OS was censored at the last date for which the participant provided consent for follow-up contact. The Kaplan-Meier method was used to estimate median parameters.
Timepoint [1] 0 0
Randomization to Date of Death Due to Any Cause (Up to 35.8 Months)
Primary outcome [2] 0 0
Overall Survival (OS) Leiomyosarcoma (LMS) - Overall survival was defined as the time from the date of randomization to the date of death due to any cause. For each participant, prior to data analysis, a reasonable effort was made to obtain the most up-to-date status (date of death or last date known to be alive). For any participant not known to have died as of the data cutoff date, OS was censored at the date the participant was last known to be alive. For any participant who withdrew consent for survival follow-up, OS was censored at the last date for which the participant provided consent for follow-up contact. The Kaplan-Meier method was used to estimate median parameters.
Timepoint [2] 0 0
Randomization to Date of Death Due to Any Cause (Up to 35.8 Months)
Secondary outcome [1] 0 0
Progression Free Survival (PFS) - PFS was defined by (Response Evaluation Criteria In Solid Tumors RECIST v.1.1) as the time from the date of randomization to the first date of radiologic disease progression or death due to any cause. Progressive Disease (PD) is at least 20% increase in sum of diameters of target lesions, with reference being the smallest sum on study and plus absolute increase of at least 5 millimeter (mm), or unequivocal progression of non-target lesions, or 1 or more new lesions. Censoring for death or PD due to increase sum of target lesions is defined for each participant as the time from the date of randomization to the first date of radiographic documentation of 1 or more lesions. Censoring for death without progression is defined as the date of death if there is no prior or concurrent radiologic disease progression.
Timepoint [1] 0 0
Randomization to Objective Progression or Death Due to Any Cause (Up to 35.8 Months)
Secondary outcome [2] 0 0
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR) - ORR was defined as the percentage of participants achieving a best overall response of complete response (CR) + partial response (PR). CR is the disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. Best overall response is classified based on the overall responses assessed by study investigators according to RECIST v1.1.
Timepoint [2] 0 0
Randomization to Objective Disease Progression or Death Due to Any Cause (Up to 35.8 Months)
Secondary outcome [3] 0 0
Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR) - DCR was defined as the percentage of randomized participants achieving a best overall response of CR, PR, or SD per RECIST v.1.1. CR is the disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. PD is at least 20% increase in sum of diameters of target lesions, with reference being the smallest sum on study and plus absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Timepoint [3] 0 0
Randomization to Objective Disease Progression or Death Due to Any Cause (Up to 45 Months)
Secondary outcome [4] 0 0
Time to First Worsening on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores - Time to first worsening was calculated as the time from the first study drug dose to the first observation of worsening according to the EORTC QLQ-C30 Scoring Manual (Fayers et al. 2001). The EORTC QLQ-C30 self-reported general cancer instrument consists of 30 total items covered by 1 of 3 dimensions (1 global health status/QoL total score, 5 functional subscales [physical, role, cognitive, emotional, and social]), and 9 symptom subscales [fatigue/nausea/vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea]). There are 28 questions answered on a 4-point scale where 1=Not at all (best) to 4=Very Much (worst) and 2 questions answered on a 7-point scale where 1=Very poor (worst) to 7= Excellent (best). A linear transformation was used to obtain total score ranging from 0 to 100 where "worsening" was defined as an increase of at least 10 points for the symptom scales or a decrease of at least 10 points for the functional scales and the global health status/QoL scale.
Timepoint [4] 0 0
Randomization (Cycle 1) through Follow-up (Up to 35.8 Months)
Secondary outcome [5] 0 0
Change From Baseline to Maximum Improvement in Health Status Index Score on the EuroQol 5-Dimension 5-Level (EQ-5D-5L) - The EQ-5D-5L is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of a descriptive system of the respondent's health which comprises the following 5 dimensions: (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Health status was calculated from a set of item weights to derive a score of 0 to 1, with 1 representing the best health status. United Kingdom (UK) weights were applied. The analysis includes all cycles for which at least 25% of participants in each arm have an assessment. For each participant a change from baseline was calculated for every post-baseline assessment by subtracting the baseline assessment result from the current assessment result. Maximum improvement (over baseline) was determined from the set of all post-baseline change scores.
Timepoint [5] 0 0
Randomization through Follow-up (Up to 35.8 Months)
Secondary outcome [6] 0 0
Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score" - Time to first worsening of the brief pain inventory short form modified (mBPI-sf) "worst pain score" was defined as the time from the date of the first study drug dose (baseline date) to the first date of a "worst pain" score increase of greater than or equal to (=) 2 points from baseline. The mBPI-sf is an 11-item instrument used as a multiple-item measure of cancer pain intensity ranging from 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes).
Timepoint [6] 0 0
Randomization through Follow-up (Up to 34.5 Months)
Secondary outcome [7] 0 0
Duration of Overall Response (DoR) - The duration of overall response was defined for each participant with a best response of CR or PR and measured from the time measurement criteria are first met for CR or PR (whichever is first recorded) until the first date that disease is recurrent or objective disease progression or death due to any cause is observed (taking as reference for PD the smallest measurements recorded on study).
Timepoint [7] 0 0
Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 33.4 Months)
Secondary outcome [8] 0 0
Duration of Disease Control (DDC) - Duration of disease control was defined for each participant with a best response of CR, PR, or stable disease (SD) as the time from randomization to the first date of disease progression or death due to any cause.
Timepoint [8] 0 0
Date of CR, PR, or SD to Objective Disease Progression or Death Due to Any Cause (Up to 35.8 Months)
Secondary outcome [9] 0 0
Pharmacokinetics (PK) Clearance of Olaratumab Mean Parameter Estimate - The PK systemic clearance parameter estimates from the current analysis are listed together with the population PK model estimates.
Timepoint [9] 0 0
Cycle 1- 9: Day 1 and 8, Predose, 5 minutes Post dose and then every other cycle and follow-up (30 Days)
Secondary outcome [10] 0 0
PK: Volume of Distribution at Steady State (Vss) of Olaratumab: Mean Parameter Estimate - The PK parameter estimates from the current analysis are listed together with the population PK model estimates. The Vss is the sum of central volume of distribution (V1) + peripheral volume of distribution (V2).
Timepoint [10] 0 0
Cycle 1- 9: Day 1 and 8; Predose, 5 Minutes Post dose and then every other cycle and follow-up (30 Days)

Eligibility
Key inclusion criteria
- Histologically confirmed diagnosis of advanced unresectable or metastatic soft tissue
sarcoma not amenable to curative treatment with surgery or radiotherapy. Participants
with Kaposi's sarcoma and gastrointestinal stromal tumors (GIST) will be excluded.
Note: Evidence of disease progression is required for participants that are not newly
diagnosed.

- Presence of measurable or nonmeasurable but evaluable disease as defined by the
Response Evaluation Criteria in Solid Tumors (RECIST 1.1, Eisenhauer et al. 2009).

- Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.

- The participant has not received any previous treatment with anthracyclines.

- The participant may have had any number of prior systemic cytotoxic therapies for
advanced/metastatic disease and are considered appropriate candidates for
anthracycline therapy. All previous anticancer treatments must be completed = 3 weeks
(21 days) prior to first dose of study drug.

- Availability of tumor tissue is required for study eligibility. The participant must
have consented to provide archived formalin-fixed paraffin embedded (FFPE) tumor
tissue or be subject to a pre-treatment re-biopsy of primary or metastatic tumor
tissue for future central pathology review and translational research (if archived
tissue is unavailable).

- Adequate hematologic, organ, and coagulation within 2 weeks (14 days) prior to
randomization.

- Left ventricular ejection fraction (LVEF) =50% assessed within 28 days prior to
randomization.

- Females of child-bearing potential must have a negative serum pregnancy test within 7
days prior to randomization.

- Females of child-bearing potential and males must agree to use highly effective
contraceptive precautions during the trial and up to 3 months following the last dose
of study drug.

- The participant has, in the opinion of the investigator, a life expectancy of at least
3 months.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Diagnosis of GIST or Kaposi sarcoma.

- Active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at
the time of randomization. Participants with a history of a CNS metastasis previously
treated with curative intent (for example, stereotactic radiation or surgery) that
have not progressed on follow-up imaging, have been asymptomatic for at least 60 days
and are not receiving systemic corticosteroids and or/anticonvulsants, are eligible.
Participants with signs or symptoms of neurological compromise should have appropriate
radiographic imaging performed before randomization to rule out brain metastasis.

- Prior treatment with doxorubicin, epirubicin, idarubicin, and/or other anthracyclines
or anthracenediones; the participant has received treatment with olaratumab or has
participated in a prior olaratumab trial.

- Prior radiotherapy of the mediastinal/pericardial area or whole pelvis radiation.

- The participant has symptomatic congestive heart failure (CHF), left ventricular
dysfunction (LVEF < 50%), severe myocardial insufficiency, cardiac arrhythmia, or
cardiomyopathy.

- The participant has unstable angina pectoris, angioplasty, cardiac stenting, or
myocardial infarction within 6 months of randomization.

- The participant has a QT interval calculated using Bazett's formula (QTcB) interval of
>450 milliseconds (msec) for males and >470 msec for females on screening
electrocardiogram (ECG).

- Females who are pregnant or breastfeeding.

- Known allergy to any of the treatment components including a history of allergic
reactions attributed to compounds of chemical or biological composition similar to
olaratumab.

- The participant has a known active fungal, bacterial, or viral infection including
human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not
required).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
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. - Camperdown
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment outside Australia
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The main purpose of this study is to evaluate the efficacy of the combination of doxorubicin
plus the study drug known as olaratumab versus doxorubicin plus placebo in participants with
advanced or metastatic soft tissue sarcoma.
Trial website
https://clinicaltrials.gov/show/NCT02451943
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications