Trial · NCT01222767
Study of Zalypsis® (PM00104) in Patients With Unresectable Locally Advanced and/or Metastatic Ewing Family of Tumors (EFT) Progressing After at Least One Prior Line of Chemotherapy
NCT01222767, Phase 2, Completed, PharmaMar; results first posted 2021-10-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Zalypsis® (PM00104) in Patients With Unresectable Locally Advanced and/or Metastatic Ewing Family of Tumors (EFT) Progressing After at Least One Prior Line of Chemotherapy. Trials, record NCT01222767. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01222767
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Zalypsis® (PM00104) in Patients With Unresectable Locally Advanced and/or Metastatic Ewing Family of Tumors (EFT) Progressing After at Least One Prior Line of Chemotherapy
- NCT number
- NCT01222767
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- PharmaMar
- Conditions
- Ewing's Sarcoma, Primitive Neuroectodermal Tumor (PNET), Askin's Tumor of the Chest Wall, Extraosseous Ewing's Sarcoma (EOE)
- Interventions
- Zalypsis
- First posted
- 2010-10-18
- Last updated
- 2021-10-29
- Results first posted
- 2021-10-29
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | At baseline and every other cycle (± 1 week) until evidence of PD, up to 2 years | Overall response rate (ORR), defined as the percentage of patients with confirmed objective response (OR), either CR or PR according to the RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; RECIST, Response Evaluation Criteria in Solid Tumors |
| Secondary | Best Tumor Response | At baseline and every other cycle (± 1 week) until evidence of PD, up to 2 years | Best tumor response was defined as the best response achieved during the study according to RECIST v1.1 CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; RECIST, Response Evaluation Criteria in Solid Tumors |
| Secondary | Progression-free Survival | From the first day of study treatment to the day of negative assessment (progression or death), start of subsequent antitumor therapy, or last tumor evaluation, up to 2 years | Progression-free survival (PFS), defined as the time from the first day of study treatment to the day of negative assessment (progression or death), start of subsequent antitumor therapy, or last tumor evaluation. PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density |
| Secondary | Progression-free Survival at 3 Months | At 3 months | Progression-free survival (PFS), defined as the time from the first day of study treatment to the day of negative assessment (progression or death), start of subsequent antitumor therapy, or last tumor evaluation. PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density |
| Secondary | Overall Survival | from the first day of treatment to the date of death, up to 2 years | Overall survival (OS), defined as the time from the first day of treatment to the date of death (or the last day when the patient was known to be alive). Survival was to be followed for up to six months after the last treatment visit of the last patient, or 12 months after the last patient was included, whichever occurred first. |
| Secondary | Overall Survival Rate at 6 Months | At 6 months | Overall survival (OS), defined as the time from the first day of treatment to the date of death (or the last day when the patient was known to be alive). Survival was to be followed for up to six months after the last treatment visit of the last patient, or 12 months after the last patient was included, whichever occurred first. |
| Secondary | Overall Survival Rate at 12 Months | At 12 months | Overall survival (OS), defined as the time from the first day of treatment to the date of death (or the last day when the patient was known to be alive). Survival was to be followed for up to six months after the last treatment visit of the last patient, or 12 months after the last patient was included, whichever occurred first. |
| Secondary | PM00104 Plasma PK Parameters (Cmax) at First Infusion | 0 (Pre-infusion) and 5 min, 30 min, 2 hours, 6 hours, 24 hours, 48 hours and 168 hours after the end of first infusion (Day 1) | Cmax Maximum plasma concentration, directly determined from the experimental data |
| Secondary | PM00104 Plasma PK Parameters (AUC) at First Infusion | 0 (Pre-infusion) and 5 min, 30 min, 2 hours, 6 hours, 24 hours, 48 hours and 168 hours after the end of first infusion (Day 1) | AUC Area under the plasma concentration-time curve from time zero to infinity |
| Secondary | PM00104 Plasma PK Parameters (Cmax) at Second Infusion | 0 (Pre-infusion) and 5 min, 30 min, 2 hours, 6 hours, 24 hours, 48 hours and 168 hours after the end of second infusion (Day 8) | Cmax Maximum plasma concentration, directly determined from the experimental data |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | At baseline and every other cycle (± 1 week) until evidence of PD, up to 2 years | One patient never treated | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Best Tumor Response | At baseline and every other cycle (± 1 week) until evidence of PD, up to 2 years | One patient never treated Two patients were non-evaluable for efficacy because they were withdrawn due to toxicity without any tumor assessment after the start of study treatment and were considered as treatment failures | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival | From the first day of study treatment to the day of negative assessment (progression or death), start of subsequent antitumor therapy, or last tumor evaluation, up to 2 years | One patient never treated | months | MEDIAN |
| SECONDARY | Progression-free Survival at 3 Months | At 3 months | One patient never treated | percentage of participants | NUMBER |
| SECONDARY | Overall Survival | from the first day of treatment to the date of death, up to 2 years | One patient never treated | months | MEDIAN |
| SECONDARY | Overall Survival Rate at 6 Months | At 6 months | One patient never treated | percentage of participants | NUMBER |
| SECONDARY | Overall Survival Rate at 12 Months | At 12 months | One patient never treated | percentage of participants | NUMBER |
| SECONDARY | PM00104 Plasma PK Parameters (Cmax) at First Infusion | 0 (Pre-infusion) and 5 min, 30 min, 2 hours, 6 hours, 24 hours, 48 hours and 168 hours after the end of first infusion (Day 1) | Fourteen of the 16 patients treated in this study had plasma profiles | μg/l | MEAN |
| SECONDARY | PM00104 Plasma PK Parameters (AUC) at First Infusion | 0 (Pre-infusion) and 5 min, 30 min, 2 hours, 6 hours, 24 hours, 48 hours and 168 hours after the end of first infusion (Day 1) | Fourteen of the 16 patients treated in this study had plasma profiles | h*μg/l | MEAN |
| SECONDARY | PM00104 Plasma PK Parameters (Cmax) at Second Infusion | 0 (Pre-infusion) and 5 min, 30 min, 2 hours, 6 hours, 24 hours, 48 hours and 168 hours after the end of second infusion (Day 8) | Eleven of the 16 patients treated in this study had plasma profiles at second infusion | μg/l | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | PM00104 | 0 | Participants | ||
| Best Tumor Response | PM00104 | SD | 4 | Participants | |
| Best Tumor Response | PM00104 | PD | 10 | Participants | |
| Progression-free Survival | PM00104 | 1.8 | 95% Confidence Interval 0.9 to 3.5 | months | |
| Progression-free Survival at 3 Months | PM00104 | 28.6 | 95% Confidence Interval 4.9 to 52.2 | percentage of participants | |
| Overall Survival | PM00104 | NA | 95% Confidence Interval NA to NA | months | |
| Overall Survival Rate at 6 Months | PM00104 | 62.5 | 95% Confidence Interval 38.8 to 86.2 | percentage of participants | |
| Overall Survival Rate at 12 Months | PM00104 | 54.7 | 95% Confidence Interval 29.5 to 79.9 | percentage of participants | |
| PM00104 Plasma PK Parameters (Cmax) at First Infusion | PM00104 | 21.23 | Standard Deviation 8.35 | μg/l | |
| PM00104 Plasma PK Parameters (AUC) at First Infusion | PM00104 | 87.06 | Standard Deviation 75.49 | h*μg/l |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PM00104 | 17 | |
| Overall Study | Received Treatment | PM00104 | 16 | |
| Overall Study | COMPLETED | PM00104 | 0 | |
| Overall Study | NOT COMPLETED | PM00104 | 17 |
Source ClinicalTrials.gov
Adverse events72
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | PM00104 | 2 | 16 | 4 |
| other | Neutropenia | Blood and lymphatic system disorders | PM00104 | 7 | 16 | 11 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | PM00104 | 2 | 16 | 2 |
| other | Palpitations | Cardiac disorders | PM00104 | 3 | 16 | 3 |
| other | Pericardial effusion | Cardiac disorders | PM00104 | 1 | 16 | 1 |
| other | Tachycardia | Cardiac disorders | PM00104 | 2 | 16 | 2 |
| other | Ear congestion | Ear and labyrinth disorders | PM00104 | 1 | 16 | 1 |
| other | Tinnitus | Ear and labyrinth disorders | PM00104 | 1 | 16 | 1 |
| other | Eye swelling | Eye disorders | PM00104 | 1 | 16 | 1 |
| other | Myopia | Eye disorders | PM00104 | 1 | 16 | 1 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PM00104 | 7 | 16 |
| Total, other adverse events | PM00104 | 16 | 16 |
| Total, serious adverse events | PM00104 | 2 | 16 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01222767
GET https://conductscience.org/api/trials/v1/NCT01222767/events?page=2