A Phase 1 interventional study of Olaratumab and Doxorubicin in Soft Tissue Sarcoma, sponsored by Eli Lilly and Company. Completed at 6 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-10.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate the safety of ifosfamide when added to the combination regimen of olaratumab and doxorubicin in participants with advanced or metastatic soft tissue sarcoma (STS).
1,607 studies on the registry are indexed under Sarcoma; 366 are open to participants now.
This study's enrollment of 24 is below the median of 40 across 1,255 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
If female and of , must:
Exclusion Criteria:
Have a history of another primary , with the exception of:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Olaratumab 15 milligrams per kilogram (mg/kg) on Days 1 and 8 of a 21-day cycle, in combination with doxorubicin and ifosfamide was administered. When the safety of the 15-mg/kg dose of olaratumab was established, a 20-mg/kg loading dose cycle of olaratumab on Days 1 and 8 of a 21-day cycle in Cycle 1 only, followed by 15 mg/kg on Days 1 and 8 of subsequent cycles in combination with doxorubicin and ifosfamide plus mesna, was administered.
Drug: Olaratumab · Drug: Doxorubicin · Drug: Ifosfamide · Drug: Mesna
Administered IV
Also known as: LY3012207
Administered IV
Administered IV
Administered per standard of care
Number of Participants With Olaratumab Dose Limiting Toxicities (DLTs)
A Dose Limiting Toxicity is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfills any one of the following criteria, graded according to the NCI-CTCAE Version 4.0: 1. Grade 3 or 4 febrile neutropenia, or sepsis., or 2. Grade 4 neutropenia lasting 7 days or longer. 3. Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by hemorrhage. 4. Nonhematologic Grade ≥3 toxicity, except for toxicities (such as nausea, vomiting, transient electrolyte abnormalities, or diarrhoea) that can be controlled with optimal medical management within 48 hours or clinically non-significant laboratory abnormalities.
Time frame: Cycle 1 (Up To 24 days)
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Olaratumab
PK: Cmax of olaratumab.
Time frame: Cycle 1 - Day 1 (predose, end of infusion, 2 hours post olaratumab (olara), 6 hours post olara, 24 hours post olara, 72 hours post olara), Day 8 (predose, end of infusion, 2 hours post-olara, 6 hours post olara, 48 hours post olara, 168 hours post olara)
PK: Maximum Serum Concentration (Cmax,ss) of Olaratumab at Steady-state
PK: Cmax of olaratumab at steady-state.
Time frame: Cycle 3 - Day 1 (predose, end of infusion, 2 hours post olara, 5 hours post olara, 24 hours post olara, 72 hours post olara), Day 8 (predose, end of infusion, 2 hours post-olara, 5 hours post olara, 48 hours post olara, 168 hours post olara)
PK: Trough Serum Concentration (Cmin)
PK: Cmin of olaratumab.
Time frame: Cycle 1 - Day 1 (predose, end of infusion, 2 hours post olaratumab (olara), 6 hours post olara, 24 hours post olara, 72 hours post olara), Day 8 (predose, end of infusion, 2 hours post-olara, 6 hours post olara, 48 hours post olara, 168 hours post olara)
PK: Trough Serum Concentration (Cmin,ss) of Olaratumab at Steady-state
PK: Cmin of olaratumab at steady-state.
Time frame: Cycle 3 - Day 1 (predose, end of infusion, 2 hours post olara, 5 hours post olara, 24 hours post olara, 72 hours post olara), Day 8 (predose, end of infusion, 2 hours post-olara, 5 hours post olara, 48 hours post olara, 168 hours post olara)
Number of Participants With Anti-Olaratumab Antibodies
Participants with treatment-emergent anti-drug antibody (TE ADA) positive were 1) a participant with a 4-fold (2 dilutions) increase over a positive baseline antibody titer; or 2) for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.
Time frame: Baseline through Follow-up (Up To 21 Months)
Objective Response Rate (ORR): Number of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR)
Objective response rate is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
Time frame: Baseline up to Short-Term Follow-Up Period (Up To 21 Months)
Progression Free Survival (PFS)
Progression-free survival time was measured from randomization until the date of objective progression as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), or death from any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants who have neither progressed nor died were censored at the day of their last radiographic tumor assessment, if available, or date of randomization if no post-baseline radiographic assessment is available.
Time frame: Baseline to Objective Disease Progression or Death Due to Any Cause (Up To 21 Months)
Duration of Response (DoR)
Duration of response is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression will be censored at the time of the last adequate tumor assessment.
Time frame: Date of Complete Response (CR) or Partial Response (PR) to Objective Disease Progression or Death Due to Any Cause (Up To 21 Months)
Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD)
Disease control rate (DCR) is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Time frame: Baseline until Disease Progression or Death Due to Any Cause (Up To 21 Months)
Overall Survival (OS)
Overall survival is defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date for a particular analysis, overall survival duration was censored for that analysis at the date of last prior contact.
Time frame: Baseline to Date of Death Due to Any Cause (Up To 21 Months)
| Milestone | Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide | Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide |
|---|---|---|
| Started | 16 | 8 |
| Received at least 1 dose of study drug | 16 | 8 |
| Completed | 9 | 2 |
| Not completed | 7 | 6 |
| Withdrew: Physician decision | 5 | 6 |
| Withdrew: Withdrawal by subject | 2 | 0 |
A Dose Limiting Toxicity is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfills any one of the following criteria, graded according to the NCI-CTCAE Version 4.0: 1. Grade 3 or 4 febrile neutropenia, or sepsis., or 2. Grade 4 neutropenia lasting 7 days or longer. 3. Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by hemorrhage. 4. Nonhematologic Grade ≥3 toxicity, except for toxicities (such as nausea, vomiting, transient electrolyte abnormalities, or diarrhoea) that can be controlled with optimal medical management within 48 hours or clinically non-significant laboratory abnormalities.
| Participants | Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide | Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide |
|---|---|---|
| Number of Participants With Olaratumab Dose Limiting Toxicities (DLTs) | 4 | 4 |
PK: Cmax of olaratumab.
| micrograms per milliliter (μg/mL) | Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide | Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide |
|---|---|---|
| Cycle 1 Day 1 | 408 ± 25 | 508 ± 27 |
| Cycle 1 Day 8 | 452 ± 28 | 671 ± 24 |
PK: Cmax of olaratumab at steady-state.
| micrograms per milliliter (μg/mL) | Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide | Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide |
|---|---|---|
| Cycle 3 Day 1 | 533 ± 22 | 494 ± 9 |
| Cycle 3 Day 8 | 523 ± 18 | 545 ± 13 |
PK: Cmin of olaratumab.
| micrograms per milliliter (μg/mL) | Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide | Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide |
|---|---|---|
| Cycle 1 Day 1 | 87.3 ± 40 | 140 ± 45 |
| Cycle 1 Day 8 | 46.7 ± 105 | 53.3 ± 143 |
PK: Cmin of olaratumab at steady-state.
| micrograms per milliliter (μg/mL) | Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide | Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide |
|---|---|---|
| Cycle 3 Day 1 | 154 ± 26 | 177 ± 17 |
| Cycle 3 Day 8 | 126 ± 35 | 115 ± 32 |
Participants with treatment-emergent anti-drug antibody (TE ADA) positive were 1) a participant with a 4-fold (2 dilutions) increase over a positive baseline antibody titer; or 2) for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.
| Participants | Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide | Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide |
|---|---|---|
| Number of Participants With Anti-Olaratumab Antibodies | 0 | 1 |
Objective response rate is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
| Participants | Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide | Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide |
|---|---|---|
| Objective Response Rate (ORR): Number of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) | 6 | 1 |
Progression-free survival time was measured from randomization until the date of objective progression as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), or death from any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants who have neither progressed nor died were censored at the day of their last radiographic tumor assessment, if available, or date of randomization if no post-baseline radiographic assessment is available.
| Months | Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide | Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide |
|---|---|---|
| Progression Free Survival (PFS) | 9.53 (4.07 to 14.29) | 6.93 (1.28 to 6.93) |
Duration of response is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression will be censored at the time of the last adequate tumor assessment.
| Months | Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide | Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide |
|---|---|---|
| Duration of Response (DoR) | 8.25 (8.15 to 8.34) | NA (NA to NA) |
Disease control rate (DCR) is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
| Percentage of participants | Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide | Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide |
|---|---|---|
| Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD) | 81.3 | 87.5 |
Overall survival is defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date for a particular analysis, overall survival duration was censored for that analysis at the date of last prior contact.
| Months | Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide | Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide |
|---|---|---|
| Overall Survival (OS) | 16.72 (8.38 to NA) | NA (1.28 to NA) |
Collected over Up To 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide | 7/16 (43.8%) | 9/16 (56.3%) | 16/16 (100%) |
| Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide | 2/8 (25%) | 7/8 (87.5%) | 8/8 (100%) |
| Event | Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide | Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide |
|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 6/16 | 4/8 |
| PneumoniaInfections and infestations | 0/16 | 2/8 |
| Platelet count decreasedInvestigations | 2/16 | 2/8 |
| AnaemiaBlood and lymphatic system disorders | 2/16 | 1/8 |
| Atrial fibrillationCardiac disorders | 0/16 | 1/8 |
| FatigueGeneral disorders | 2/16 | 0/8 |
| FractureInjury, poisoning and procedural complications | 0/16 | 1/8 |
| Blood creatinine increasedInvestigations | 0/16 | 1/8 |
| White blood cell count decreasedInvestigations | 0/16 | 1/8 |
| Device dislocationProduct Issues | 0/16 | 1/8 |
| Event | Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide | Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 11/16 | 8/8 |
| NauseaGastrointestinal disorders | 14/16 | 6/8 |
| FatigueGeneral disorders | 12/16 | 6/8 |
| ConstipationGastrointestinal disorders | 11/16 | 3/8 |
| NeutropeniaBlood and lymphatic system disorders | 9/16 | 4/8 |
| HyperglycaemiaMetabolism and nutrition disorders | 0/16 | 4/8 |
| LeukopeniaBlood and lymphatic system disorders | 4/16 | 3/8 |
| ThrombocytopeniaBlood and lymphatic system disorders | 5/16 | 3/8 |
| VomitingGastrointestinal disorders | 6/16 | 3/8 |
| Alanine aminotransferase increasedInvestigations | 5/16 | 3/8 |
All participants who received at least one dose of study drug.
| Age, Continuous(years) | Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide | Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide | Total |
|---|---|---|---|
| Mean | 42.6 ± 11.1 | 49.8 ± 11.1 | 45.0 ± 11.4 |
| Sex: Female, Male(Participants) | Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide | Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide | Total |
|---|---|---|---|
| Female | 9 | 5 | 14 |
| Male | 7 | 3 | 10 |
| Ethnicity (NIH/OMB)(Participants) | Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide | Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 3 | 6 |
| Not Hispanic or Latino | 6 | 4 | 10 |
| Unknown or Not Reported | 7 | 1 | 8 |
| Race (NIH/OMB)(Participants) | Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide | Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 15 | 8 | 23 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide | Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide | Total |
|---|---|---|---|
| United States | 6 | 5 | 11 |
| Italy | 3 | 0 | 3 |
| Germany | 7 | 3 | 10 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Olaratumab · Doxorubicin · Ifosfamide