Trial · NCT01759303
Study of Pazopanib in the Treatment of Osteosarcoma Metastatic to the Lung
NCT01759303, Phase 2, Terminated, Emerald Clinical Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Pazopanib in the Treatment of Osteosarcoma Metastatic to the Lung. Trials, record NCT01759303. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01759303
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Pazopanib in the Treatment of Osteosarcoma Metastatic to the Lung
- NCT number
- NCT01759303
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Emerald Clinical Inc.
- Conditions
- Osteosarcoma, Metastatic Osteosarcoma
- Interventions
- pazopanib
- First posted
- 2013-01-03
- Last updated
- 2021-04-13
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 4-month Progression Free Survival (PFS) per RECIST version 1.1 guidelines | 4 months from the beginning of study treatment | The primary objective of the study is to evaluate the 4-month PFS (with demonstrated increase in tumor doubling time) of eligible subjects treated with pazopanib according to RECIST version 1.1 guidelines. Tumor growth rate will be calculated by measuring growth at the specified intervals for the single, longest dimension of the tumor(s) (RECIST) and by calculating the area of the tumor(s), which will be the product of the longest dimension of the tumor(s) multiplied by its longest, perpendicular dimension (WHO). Progressive disease (PD) for target lesions is defined as at least a 20% increase in the sum of diameters of the target lesions taking as reference the smallest sum on study, and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. PD for non-target lesions is defined as unequivocal appearance of one or more new malignant lesions. Unequivocal progression of existing non-target lesions. |
| Secondary | 4-month PFS per WHO criteria | 4 months from the beginning of study treatment | The primary objective of the study is to evaluate the 4-month PFS (with demonstrated increase in tumor doubling time) of eligible subjects treated with pazopanib according to RECIST version 1.1 guidelines. The study statistician will calculate tumor growth rate per WHO criteria based on bidimensional tumor measurements (i.e., longest dimension of the tumor(s) and its longest perpendicular dimension) at each imaging time point. |
| Secondary | Pharmacokinetics evaluation | Day 1 of Cycles 2 and 3 (Approximately 5 and 7 weeks from the start of study treatment) | Evaluate the pharmacokinetics of pazopanib to define correlation of minimal drug concentrations with PFS, RR, duration of response, OS, and safety. Samples will be collected on Day 1 of Cycles 2 and 3 for plasma pazopanib trough PKs to assess the population of subjects with concentration greater than the target of 15 µg/mL. |
| Secondary | Tumor growth kinetics | Assessed at Week -4 and 3 to 5 days prior to study treatment, approximately 4 weeks from the start of study treatment and every 6 weeks thereafter until the patient progresses or 60 months from the end of treatment, whichever occurs first | Evaluate the tumor growth kinetics, both within subject, and across subjects over time and the change associated with pazopanib. Examine the correlation between tumor growth kinetics with pazopanib pharmacokinetics. |
| Secondary | Response rate per RECIST version 1.1 | Assessed at Week -4 and 3 to 5 days prior to study treatment, approximately 4 weeks from the start of study treatment and every 6 weeks thereafter until the patient progresses or 60 months from the end of treatment, whichever occurs first | Response rate (RR), where response is defined as complete response (CR) or partial response (PR) according to RECIST version 1.1 guidelines. |
| Secondary | Overall Survival (OS) | Cycle 1 Day 1 (start of study treatment) up to death or 60 months after the end of study treatment, whichever occurs first | The time origin for OS will be Cycle 1, Day 1. Subjects will be followed for up to 24 months after the end of treatment or until death, lost to follow-up, or withdrawal of consent, whichever occurs first. |
| Secondary | PFS | Assessed at Week -4 and 3 to 5 days prior to study treatment, approximately 4 weeks from the start of study treatment and every 6 weeks thereafter until the patient progresses or 60 months from the end of treatment, whichever occurs first | The time origin for PFS will be Cycle 1, Day 1. Repeat radiological imaging will be conducted after every 2 cycles of treatment (approximately 8 weeks)to evaluate disease status per RECIST v.1.1 and WHO criteria. Subjects who discontinue study treatment for reasons other than disease progression will continue to have their disease status reported every 3 months post end of treatment up to 60 months. |
| Secondary | Response rate per WHO criteria | Assessed at Week -4 and 3 to 5 days prior to study treatment, approximately 4 weeks from the start of study treatment and every 6 weeks thereafter until the patient progresses or 60 months from the end of treatment, whichever occurs first | Response rate (RR), where response is defined as complete response (CR) or partial response (PR) per WHO criteria. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35075361 | DERIVED |
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 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/NCT01759303
GET https://conductscience.org/api/trials/v1/NCT01759303/registered