A Phase 2 interventional study of trabectedin and pharmacological study in Previously Treated Childhood Rhabdomyosarcoma, Recurrent Childhood Rhabdomyosarcoma and Recurrent Childhood Soft Tissue Sarcoma, sponsored by Children's Oncology Group. Completed at 14 sites in 2 countries. Open to participants aged 12 Months to 50 Years. Per ClinicalTrials.gov, last updated 2018-09-14.
Sponsored by Children's Oncology Group · Phase 2, Interventional, and Treatment
This phase II trial is studying how well trabectedin works in treating young patients with recurrent or refractory soft tissue sarcoma or Ewing's family of tumors. Drugs used in chemotherapy such as trabectedin use different ways to stop tumor cells from dividing so they stop growing or die.
PRIMARY OBJECTIVES:
I. Determine the response rate in pediatric patients with recurrent or refractory soft tissue sarcomas or Ewing's sarcoma family of tumors treated with ecteinascidin 743 (trabectedin).
II. Determine the toxicity of this drug in these patients. III. Determine the pharmacokinetics of this drug in these patients.
OUTLINE:
Patients receive trabectedin IV over 3 hours on day 1. Treatment repeats every 21days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 5 years.
250 studies on the registry are indexed under Sarcoma, Ewing; 69 are open to participants now.
This study's enrollment of 50 is above the median of 36 across 204 interventional studies indexed under Sarcoma, Ewing.
Browse Sarcoma, Ewing studies →Children's Oncology Group is the lead sponsor of 448 studies on the registry; 36 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
confirmed recurrent or sarcoma tumors, including the following:
by imaging studies
No significant amount of liver disease, defined as the following:
No concurrent inhibitors, including the following:
Maximum creatinine based on age as follows:
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.
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 diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
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.
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 (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.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
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.
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.
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. A cohort of 6 patients will be enrolled at the 1.3 mg/m2 dose level.
Drug: trabectedin · Other: pharmacological study
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Six toxicity-evaluable patients are assigned this treatment.
Drug: trabectedin · Other: pharmacological study
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Drug: trabectedin · Other: pharmacological study
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Drug: trabectedin · Other: pharmacological study
Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Drug: trabectedin · Other: pharmacological study
Given IV
Also known as: Ecteinascidin, ET 743, Yondelis
Correlative studies
Also known as: pharmacological studies
Response (Complete Response [CR] and Partial Response [PR])
Any patient who is enrolled and receives at least one dose of trabectedin will be considered evaluable for response if the individual receives at least one dose of trabectedin and: (1) is removed from protocol therapy because of progressive disease where progressive disease is documented either by imaging studies or clinical progression; or (2) has at least one radiographic evaluation of disease status after the start of protocol therapy and is not electively removed from protocol therapy with stable disease or is not lost to follow-up with stable disease. Patients who achieve a complete response (CR) - disappearance of all target lesions or partial response (PR) - \>=30% decrease in the sum of the longest diameter of target lesions according to the RECIST criteria will be considered responders for the study design. All other patients who are evaluable for response will be considered non-responders for the study.
Time frame: Twenty-six (26) cycles of chemotherapy or termination of protocol therapy, whichever occurs first.
Number of Patients With Dose-Limiting Toxicity (DLT)
Any Grade 3 or Grade 4 non-hematologic toxicity attributable to the Investigational drug with the specific exclusion of: Grade 3 nausea and vomiting; Grade 3 transaminase (AST/ALT) elevation that return to less than or equal to Grade 1 or baseline prior to the time for the next treatment cycle; Grade 3 fever or infection; Alopecia; Grade 4 neutropenia of \> 7 days duration or Grade 4 thrombocytopenia of \> 7 days duration, which requires transfusion therapy on greater than 2 occasions in 7 days, or which causes a delay of more than 14 days beyond the planned interval between treatment cycles.
Time frame: 1 Cycle
Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Maximum Plasma Concentration (Cmax) of Trabectedin
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Cmax was derived for each patient.
Time frame: From baseline up to168 hours after trabectedin infusion in course 1
Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Apparent Volume at Steady State (Vss) of Trabectedin
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Vss was derived for each patient.
Time frame: From baseline up to168 hours after trabectedin infusion in course 1
Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Half-life of Trabectedin
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Half-life was derived for each patient.
Time frame: From baseline up to168 hours after trabectedin infusion in course 1
Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Area Under the Curve (AUC) of Trabectedin
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated AUC was derived for each patient.
Time frame: From baseline up to168 hours after trabectedin infusion in course 1
Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Clearance of Trabectedin
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Clearance was derived for each patient.
Time frame: From baseline up to168 hours after trabectedin infusion in course 1
| Milestone | Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients | Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients | Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma | Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma | Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma |
|---|---|---|---|---|---|
| Started | 8 | 6 | 8 | 20 | 8 |
| Completed | 0 | 0 | 0 | 0 | 0 |
| Not completed | 8 | 6 | 8 | 20 | 8 |
| Withdrew: Death | 1 | 1 | 0 | 0 | 1 |
| Withdrew: Lack of efficacy | 6 | 4 | 5 | 15 | 5 |
| Withdrew: Physician decision | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 1 | 0 | 0 |
| Withdrew: Adverse event | 0 | 0 | 2 | 4 | 2 |
| Withdrew: Removed from prot thpy prior to chemo | 0 | 0 | 0 | 1 | 0 |
Any patient who is enrolled and receives at least one dose of trabectedin will be considered evaluable for response if the individual receives at least one dose of trabectedin and: (1) is removed from protocol therapy because of progressive disease where progressive disease is documented either by imaging studies or clinical progression; or (2) has at least one radiographic evaluation of disease status after the start of protocol therapy and is not electively removed from protocol therapy with stable disease or is not lost to follow-up with stable disease. Patients who achieve a complete response (CR) - disappearance of all target lesions or partial response (PR) - \>=30% decrease in the sum of the longest diameter of target lesions according to the RECIST criteria will be considered responders for the study design. All other patients who are evaluable for response will be considered non-responders for the study.
| participants | Trabectedin 1.5 mg/m2- Feasibility in All Patients(Group 2) | Trabectedin 1.5 mg/m2- Efficacy in Ewing Sarcoma (Group 3) | Trabectedin 1.5 mg/m2- Efficacy in Rhabdomyosarcoma (Group 4) | Trabectedin 1.5 mg/m2-efficacy in Nonrhabdomyosarcoma(Group 5) |
|---|---|---|---|---|
| Response (Complete Response [CR] and Partial Response [PR]) | 1 | 0 | 0 | 0 |
Any Grade 3 or Grade 4 non-hematologic toxicity attributable to the Investigational drug with the specific exclusion of: Grade 3 nausea and vomiting; Grade 3 transaminase (AST/ALT) elevation that return to less than or equal to Grade 1 or baseline prior to the time for the next treatment cycle; Grade 3 fever or infection; Alopecia; Grade 4 neutropenia of \> 7 days duration or Grade 4 thrombocytopenia of \> 7 days duration, which requires transfusion therapy on greater than 2 occasions in 7 days, or which causes a delay of more than 14 days beyond the planned interval between treatment cycles.
| participants | Trabectedin 1.3 mg/m2- Feasibility in All Patients (Group 1) | Trabectedin 1.5 mg/m2- Feasibility in All Patients (Group 2) |
|---|---|---|
| Number of Patients With Dose-Limiting Toxicity (DLT) | 1 | 0 |
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Cmax was derived for each patient.
| ng/mL | Trabectedin at 1.5 mg/m2- Efficacy in Ewing Sarcoma (Group 3) | Trabectedin 1.5 mg/m2- Efficacy in Rhabdomyosarcoma (Group 4) | Trabectedin 1.5 mg/m2-efficacy in Nonrhabdomyosarcoma(Group 5) |
|---|---|---|---|
| Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Maximum Plasma Concentration (Cmax) of Trabectedin | 3.643333333 ± 4.08 | 2.285 ± 0.191 | 1.889 ± 1.26 |
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Vss was derived for each patient.
| L | Trabectedin at 1.5 mg/m2- Efficacy in Ewing Sarcoma (Group 3) | Trabectedin 1.5 mg/m2- Efficacy in Rhabdomyosarcoma (Group 4) | Trabectedin 1.5 mg/m2-efficacy in Nonrhabdomyosarcoma(Group 5) |
|---|---|---|---|
| Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Apparent Volume at Steady State (Vss) of Trabectedin | 1860.666667 ± 999.9 | 1340.5 ± 439 | 3269.5 ± 269.4 |
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Half-life was derived for each patient.
| hours | Trabectedin at 1.5 mg/m2- Efficacy in Ewing Sarcoma (Group 3) | Trabectedin 1.5 mg/m2- Efficacy in Rhabdomyosarcoma (Group 4) | Trabectedin 1.5 mg/m2-efficacy in Nonrhabdomyosarcoma(Group 5) |
|---|---|---|---|
| Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Half-life of Trabectedin | 47.4 ± 17.0 | 49.5 ± 1.70 | 63.4 ± 22.4 |
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated AUC was derived for each patient.
| ng/(mLxh) | Trabectedin at 1.5 mg/m2- Efficacy in Ewing Sarcoma (Group 3) | Trabectedin 1.5 mg/m2- Efficacy in Rhabdomyosarcoma (Group 4) | Trabectedin 1.5 mg/m2-efficacy in Nonrhabdomyosarcoma(Group 5) |
|---|---|---|---|
| Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Area Under the Curve (AUC) of Trabectedin | 184.9 ± 193 | 75.7 ± 43.3 | 41.2 ± 18.7 |
The plasma concentrations at each time point were determined by miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method. The plasma concentration-versus-time data of trabectedin were estimated using non-compartmental methods. Individual time points were not available, so one estimated Clearance was derived for each patient.
| L/hr | Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma | Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma | Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma |
|---|---|---|---|
| Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method : Clearance of Trabectedin | 20.5786891 ± 17.9 | 18.11833775 ± 3.32 | 63.8304367 ± 29.7 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients | — | 3/8 (37.5%) | 6/8 (75%) |
| Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients | — | 0/6 (0%) | 4/6 (66.7%) |
| Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma | — | 1/8 (12.5%) | 6/8 (75%) |
| Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma | — | 5/19 (26.3%) | 15/19 (78.9%) |
| Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma | — | 3/8 (37.5%) | 6/8 (75%) |
| Event | Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients | Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients | Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma | Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma | Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma |
|---|---|---|---|---|---|
| Acute kidney injuryRenal and urinary disorders | 0/8 | 0/6 | 0/8 | 0/19 | 1/8 |
| Alanine aminotransferase increasedInvestigations | 1/8 | 0/6 | 1/8 | 1/19 | 0/8 |
| Aspartate aminotransferase increasedInvestigations | 1/8 | 0/6 | 1/8 | 2/19 | 0/8 |
| Back painMusculoskeletal and connective tissue disorders | 0/8 | 0/6 | 1/8 | 0/19 | 0/8 |
| Death NOSGeneral disorders | 1/8 | 0/6 | 0/8 | 0/19 | 1/8 |
| GGT increasedInvestigations | 1/8 | 0/6 | 1/8 | 1/19 | 0/8 |
| HyponatremiaMetabolism and nutrition disorders | 1/8 | 0/6 | 0/8 | 0/19 | 0/8 |
| Vascular access complicationInjury, poisoning and procedural complications | 0/8 | 0/6 | 0/8 | 0/19 | 1/8 |
| DehydrationMetabolism and nutrition disorders | 0/8 | 0/6 | 0/8 | 1/19 | 0/8 |
| Eye painEye disorders | 0/8 | 0/6 | 0/8 | 1/19 | 0/8 |
| Event | Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients | Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients | Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma | Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma | Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma |
|---|---|---|---|---|---|
| Neutrophil count decreasedInvestigations | 4/8 | 2/6 | 2/8 | 10/19 | 2/8 |
| Alanine aminotransferase increasedInvestigations | 3/8 | 3/6 | 1/8 | 9/19 | 3/8 |
| AnemiaBlood and lymphatic system disorders | 4/8 | 2/6 | 3/8 | 5/19 | 1/8 |
| Aspartate aminotransferase increasedInvestigations | 3/8 | 3/6 | 1/8 | 6/19 | 3/8 |
| White blood cell decreasedInvestigations | 3/8 | 1/6 | 2/8 | 9/19 | 2/8 |
| GGT increasedInvestigations | 1/8 | 0/6 | 0/8 | 5/19 | 3/8 |
| Infections and infestations - Other, specifyInfections and infestations | 3/8 | 0/6 | 0/8 | 0/19 | 0/8 |
| Platelet count decreasedInvestigations | 0/8 | 0/6 | 2/8 | 5/19 | 0/8 |
| HypophosphatemiaMetabolism and nutrition disorders | 2/8 | 0/6 | 0/8 | 0/19 | 0/8 |
| Lymphocyte count decreasedInvestigations | 1/8 | 1/6 | 1/8 | 4/19 | 2/8 |
| Age, Continuous(years) | Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients | Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients | Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma | Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma | Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma | Total |
|---|---|---|---|---|---|---|
| Median | 18.5 (8 to 24) | 15.5 (8 to 21) | 16 (8 to 20) | 14.5 (4 to 22) | 16 (8 to 21) | 15.5 (4 to 24) |
| Sex: Female, Male(Participants) | Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients | Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients | Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma | Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma | Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma | Total |
|---|---|---|---|---|---|---|
| Female | 1 | 2 | 3 | 11 | 2 | 19 |
| Male | 7 | 4 | 5 | 9 | 6 | 31 |
| Ethnicity (NIH/OMB)(Participants) | Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients | Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients | Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma | Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma | Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 0 | 3 | 3 | 7 |
| Not Hispanic or Latino | 8 | 5 | 0 | 16 | 5 | 34 |
| Unknown or Not Reported | 0 | 0 | 8 | 1 | 0 | 9 |
| Race (NIH/OMB)(Participants) | Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients | Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients | Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma | Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma | Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 1 | 1 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 0 | 5 | 1 | 7 |
| White | 6 | 6 | 7 | 12 | 7 | 38 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 0 | 2 | 0 | 3 |
| Region of Enrollment(participants) | Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients | Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients | Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma | Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma | Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma | Total |
|---|---|---|---|---|---|---|
| United States | 5 | 6 | 5 | 19 | 8 | 43 |
| Canada | 3 | 0 | 3 | 1 | 0 | 7 |
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Studies of the drug tested here: Trabectedin