Trial · NCT00102531
Inhalation SLIT Cisplatin (Liposomal) for the Treatment of Osteosarcoma Metastatic to the Lung
NCT00102531, Phase 1, Phase 2, Completed, Insmed Incorporated; results first posted 2017-08-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Inhalation SLIT Cisplatin (Liposomal) for the Treatment of Osteosarcoma Metastatic to the Lung. Trials, record NCT00102531. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00102531
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Inhalation SLIT Cisplatin (Liposomal) for the Treatment of Osteosarcoma Metastatic to the Lung
- NCT number
- NCT00102531
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- Insmed Incorporated
- Conditions
- Osteosarcoma Metastatic
- Interventions
- Cisplatin liposomal
- First posted
- 2005-01-31
- Last updated
- 2017-08-01
- Results first posted
- 2017-08-01
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Study Medication Was to be Considered Effective if the Population Response Rate Was Found to be Greater Than 20% and Individuals Who Demonstrated a CR or PR or Whose Tumours Demonstrated a Grade 3 or 4 Histologic Response at the Time of Surgery. | 4 to 48 weeks |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Study Medication Was to be Considered Effective if the Population Response Rate Was Found to be Greater Than 20% and Individuals Who Demonstrated a CR or PR or Whose Tumours Demonstrated a Grade 3 or 4 Histologic Response at the Time of Surgery. | 4 to 48 weeks | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
The Study Medication Was to be Considered Effective if the Population Response Rate Was Found to be Greater Than 20% and Individuals Who Demonstrated a CR or PR or Whose Tumours Demonstrated a Grade 3 or 4 Histologic Response at the Time of Surgery. | Cisplatin Liposomal 24 mg/m2 | CR/PR | 2 | participants | |
The Study Medication Was to be Considered Effective if the Population Response Rate Was Found to be Greater Than 20% and Individuals Who Demonstrated a CR or PR or Whose Tumours Demonstrated a Grade 3 or 4 Histologic Response at the Time of Surgery. | Cisplatin Liposomal 36 mg/m2 | CR/PR | 2 | participants | |
The Study Medication Was to be Considered Effective if the Population Response Rate Was Found to be Greater Than 20% and Individuals Who Demonstrated a CR or PR or Whose Tumours Demonstrated a Grade 3 or 4 Histologic Response at the Time of Surgery. | Cisplatin Liposomal 24 mg/m2 | Histological response | 1 | participants | |
The Study Medication Was to be Considered Effective if the Population Response Rate Was Found to be Greater Than 20% and Individuals Who Demonstrated a CR or PR or Whose Tumours Demonstrated a Grade 3 or 4 Histologic Response at the Time of Surgery. | Cisplatin Liposomal 36 mg/m2 | Histological response | 1 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cisplatin Liposomal 24 mg/m2 | 7 | |
| Overall Study | STARTED | Cisplatin Liposomal 36 mg/m2 | 12 | |
| Overall Study | COMPLETED | Cisplatin Liposomal 24 mg/m2 | 2 | |
| Overall Study | COMPLETED | Cisplatin Liposomal 36 mg/m2 | 1 | |
| Overall Study | NOT COMPLETED | Cisplatin Liposomal 24 mg/m2 | 5 | |
| Overall Study | NOT COMPLETED | Cisplatin Liposomal 36 mg/m2 | 11 |
Source ClinicalTrials.gov
Adverse events20
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 | Gastrointestinal Disorders | Gastrointestinal disorders | Cisplatin Liposomal 24 mg/m2 | 2 | 7 | |
| other | Gastrointestinal Disorders | Gastrointestinal disorders | Cisplatin Liposomal 36 mg/m2 | 4 | 12 | |
| other | General Disorders and Admin Site Conditions | General disorders | Cisplatin Liposomal 24 mg/m2 | 1 | 7 | |
| other | General Disorders and Admin Site Conditions | General disorders | Cisplatin Liposomal 36 mg/m2 | 2 | 12 | |
| other | Respiratory, Thoracic and Mediastinal Disorders | Reproductive system and breast disorders | Cisplatin Liposomal 24 mg/m2 | 3 | 7 | |
| other | Respiratory, Thoracic and Mediastinal Disorders | Reproductive system and breast disorders | Cisplatin Liposomal 36 mg/m2 | 7 | 12 | |
| other | Nervous System Disorders | Nervous system disorders | Cisplatin Liposomal 24 mg/m2 | 1 | 7 | |
| other | Nervous System Disorders | Nervous system disorders | Cisplatin Liposomal 36 mg/m2 | 1 | 12 | |
| serious | Vomiting | Gastrointestinal disorders | Cisplatin Liposomal 24 mg/m2 | 1 | 7 | |
| serious | Vomiting | Gastrointestinal disorders | Cisplatin Liposomal 36 mg/m2 | 0 | 12 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cisplatin Liposomal 24 mg/m2 | 0 | 7 |
| Total, all-cause mortality | Cisplatin Liposomal 36 mg/m2 | 0 | 12 |
| Total, other adverse events | Cisplatin Liposomal 24 mg/m2 | 4 | 7 |
| Total, other adverse events | Cisplatin Liposomal 36 mg/m2 | 8 | 12 |
| Total, serious adverse events | Cisplatin Liposomal 24 mg/m2 | 1 | 7 |
| Total, serious adverse events | Cisplatin Liposomal 36 mg/m2 | 2 | 12 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23255417 | RESULT |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cisplatin Liposomal 24 mg/m2 vs Cisplatin Liposomal 36 mg/m2: deaths from any cause | Trial comparisons |
| Cisplatin Liposomal 24 mg/m2 vs Cisplatin Liposomal 36 mg/m2: serious adverse events | Trial comparisons |
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/NCT00102531
GET https://conductscience.org/api/trials/v1/NCT00102531/registered