A Phase 3 interventional study of Trabectedin and Doxorubicin in Sarcoma, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Completed at 21 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-10.
Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of trabectedin compared to standard doxorubicin in participants with advanced translocation-related sarcomas (cancer of connective tissue cells) (TRS).
This is a randomized (study drug assigned by chance), multicenter (when more than one hospital or medical school team work on a medical research study), Phase 3 trial to evaluate the efficacy and safety of trabectedin as compared to standard doxorubicin in participants with advanced TRS. Participants will be randomized in a 1:1 ratio to either of the 2 treatment groups, that is, trabectedin or doxorubicin plus ifosfamide group. Participants in trabectedin group will receive trabectedin 1.5 milligram per square meter (mg/m\^2) given as a 24-hour continuous intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) every 3 weeks and in doxorubicin plus ifosfamide group participants will receive doxorubicin 60 or 75 mg/m\^2 intravenously every 3 weeks followed by ifosfamide 6 to 9 gram (g)/m\^2 every 3 weeks. Participants in either treatment arm will continue receiving therapy in the absence of progressive disease (PD) or intolerable side effects, until the participants' consent is withdrawn or the eligibility criteria for continuing treatment are no longer fulfilled, or when a concurrent condition precludes continuation of treatment. Efficacy will be assessed primarily by evaluating progression-free survival (PFS). Participants' safety will be monitored throughout the trial.
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's enrollment of 121 is above the median of 40 across 1,283 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is the lead sponsor of 458 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Trabectedin 1.5 milligram per square meter (mg/m\^2) will be given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
Drug: Trabectedin
Doxorubicin (as a monotherapy) 75 mg per m\^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m\^2 will be given intravenously every 3 weeks followed by ifosfamide 6 to 9 gram (g)/m\^2 every 3 weeks until disease progression.
Drug: Doxorubicin · Drug: Ifosfamide
Trabectedin 1.5 milligram per square meter (mg/m\^2) will be given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
Doxorubicin 60 or 75 mg/m\^2 will be given intravenously every 3 weeks until disease progression.
Ifosfamide 6 to 9 g/m\^2 will be given intravenously every 3 weeks until disease progression.
Progression - Free Survival (PFS)
The PFS was assessed as median number of days from the date of randomization until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.
Time frame: Every 6 weeks from randomization during the first 9 months and thereafter, every 9 weeks up to 20 months
6-month Progression - Free Survival
Percentage of participants survived for 6 months from the start of study treatment without progression of disease. Progression of the disease was associated with increasing symptoms, including pain from new or progressing lesions. Delay in disease progression generally represents a clinical benefit to the participant.
Time frame: 6 months
Percentage of Participants With Objective Response
Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial Response (PR)=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, Complete Response (CR) =Disappearance of all non-target lesions. Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants.
Time frame: Every 6 weeks during first 9 months of the study and thereafter every 9 weeks up to 20 months
Overall Survival
Overall survival defined as time from the date of randomization to the date of death. For participants who were alive at the time of analysis, overall survival was censored at the last contact date.
Time frame: Baseline up to End of Study (an average of 4 years)
Duration of Response (DOR)
The DOR is defined as the time from date of first documentation of response (CR or PR, whichever comes first) to the date of documented PD or death. PR=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, CR =Disappearance of all non-target lesions.
Time frame: Up to 20 months
| Milestone | Trabectedin | Doxorubicin Plus Ifosfamide |
|---|---|---|
| Started | 61 | 60 |
| Treated | 61 | 57 |
| Completed | 0 | 0 |
| Not completed | 61 | 60 |
| Withdrew: Death | 3 | 0 |
| Withdrew: Adverse event | 11 | 6 |
| Withdrew: Progressive disease | 22 | 13 |
| Withdrew: Participant refusal | 3 | 4 |
| Withdrew: Other | 6 | 17 |
| Withdrew: Physician decision | 16 | 17 |
| Withdrew: Randomized but not treated | 0 | 3 |
The PFS was assessed as median number of days from the date of randomization until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.
| months | Trabectedin | Doxorubicin Plus Ifosfamide |
|---|---|---|
| Progression - Free Survival (PFS) | 19.6 (5.7 to 32.3) | 8.3 (7.1 to 25.0) |
Percentage of participants survived for 6 months from the start of study treatment without progression of disease. Progression of the disease was associated with increasing symptoms, including pain from new or progressing lesions. Delay in disease progression generally represents a clinical benefit to the participant.
| percentage of participants | Trabectedin | Doxorubicin Plus Ifosfamide |
|---|---|---|
| 6-month Progression - Free Survival | 66.7 (50.6 to 82.8) | 78.3 (64.0 to 92.5) |
Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial Response (PR)=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, Complete Response (CR) =Disappearance of all non-target lesions. Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants.
| percentage of participants | Trabectedin | Doxorubicin Plus Ifosfamide |
|---|---|---|
| Percentage of Participants With Objective Response | 5.9 (1.2 to 16.2) | 27.0 (13.8 to 44.1) |
Overall survival defined as time from the date of randomization to the date of death. For participants who were alive at the time of analysis, overall survival was censored at the last contact date.
| months | Trabectedin | Doxorubicin Plus Ifosfamide |
|---|---|---|
| Overall Survival | 46.6 (27.5 to NA) | 33.5 (21.6 to NA) |
The DOR is defined as the time from date of first documentation of response (CR or PR, whichever comes first) to the date of documented PD or death. PR=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, CR =Disappearance of all non-target lesions.
| days | Trabectedin | Doxorubicin Plus Ifosfamide |
|---|---|---|
| Duration of Response (DOR) | NA (7.0 to NA) | NA (4.4 to NA) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Trabectedin | — | 24/61 (39.3%) | 55/61 (90.2%) |
| Doxorubicin Plus Ifosfamide | — | 16/57 (28.1%) | 52/57 (91.2%) |
| Event | Trabectedin | Doxorubicin Plus Ifosfamide |
|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 1/61 | 7/57 |
| Catheter related infectionInfections and infestations | 4/61 | 0/57 |
| Abdominal painGastrointestinal disorders | 0/61 | 3/57 |
| Injection site extravasationGeneral disorders | 3/61 | 0/57 |
| PyrexiaGeneral disorders | 3/61 | 2/57 |
| Device related infectionInfections and infestations | 3/61 | 0/57 |
| NeutropeniaBlood and lymphatic system disorders | 2/61 | 2/57 |
| PneumoniaInfections and infestations | 1/61 | 2/57 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/61 | 2/57 |
| AnemiaBlood and lymphatic system disorders | 2/61 | 1/57 |
| Event | Trabectedin | Doxorubicin Plus Ifosfamide |
|---|---|---|
| NauseaGastrointestinal disorders | 46/61 | 40/57 |
| FatigueGeneral disorders | 45/61 | 42/57 |
| Tumour painNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 34/61 | 33/57 |
| NeutropeniaBlood and lymphatic system disorders | 29/61 | 15/57 |
| VomitingGastrointestinal disorders | 29/61 | 16/57 |
| ConstipationGastrointestinal disorders | 27/61 | 16/57 |
| AlopeciaSkin and subcutaneous tissue disorders | 2/61 | 25/57 |
| AnorexiaMetabolism and nutrition disorders | 20/61 | 15/57 |
| Alanine aminotransferase increasedInvestigations | 19/61 | 1/57 |
| Oedema peripheralGeneral disorders | 18/61 | 6/57 |
| Age, Customized(participants) | Trabectedin | Doxorubicin Plus Ifosfamide | Total |
|---|---|---|---|
| >=18 to <=49 years | 33 | 30 | 63 |
| >=50 to <=65 years | 19 | 21 | 40 |
| >=65 years | 9 | 9 | 18 |
| Sex: Female, Male(Participants) | Trabectedin | Doxorubicin Plus Ifosfamide | Total |
|---|---|---|---|
| Female | 25 | 22 | 47 |
| Male | 36 | 38 | 74 |
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.