Trial · NCT00642941
A Study of R1507 in Participants With Recurrent or Refractory Sarcoma
NCT00642941, Phase 2, Terminated, Hoffmann-La Roche; results first posted 2021-02-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of R1507 in Participants With Recurrent or Refractory Sarcoma. Trials, record NCT00642941. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00642941
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of R1507 in Participants With Recurrent or Refractory Sarcoma
- NCT number
- NCT00642941
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 317 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Sarcoma
- Interventions
- RG1507
- First posted
- 2008-03-25
- Last updated
- 2021-02-03
- Other registries' IDs
- eudract:2007-003940-30
- Results first posted
- 2021-02-03
- Limitations and caveats
The study was closed to further enrollment due to a decision by the Sponsor to discontinue development of R1507. The decision was made based upon available data from other completed/ongoing trials of R1507 and was not due to safety concerns.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Complete or Partial Response, According to World Health Organization (WHO) Criteria in Cohorts 2 to 8 | Baseline up to 6 years (assessed at baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression) | Complete response is the disappearance of all known disease, determined by two consecutive observations not less than 4 weeks apart. Partial response is \>=50% decrease in the total tumor load of the lesions that have been measured to determine the effect of therapy not less than four weeks apart. The observations must be consecutive. |
| Primary | Progression-Free Survival (PFS) Rate According to WHO Response Criteria at 18 Weeks From Start of R2607 Treatment in Cohort 1 | Baseline up to 18 weeks (assessed at baseline, every 6 weeks until disease progression) | The PFS survival rate is a landmark analysis of progression-free survival at 18 weeks from start of treatment. Progression-free survival rate at 18 weeks is a dichotomous endpoint, with a patient categorized as alive (with either stable disease or objective response) at 18 weeks from start of treatment. |
| Primary | Percentage of Participants With Adverse Events (AEs) in Cohort 1 and 2 | Baseline up to 6 years | |
| Secondary | Percentage of Participants With Complete or Partial Response According to WHO Response Criteria in Cohort 1 | Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years) | Complete response is the disappearance of all known disease, determined by two consecutive observations not less than 4 weeks apart. Partial response is \>=50% decrease in the total tumor load of the lesions that have been measured to determine the effect of therapy not less than four weeks apart. The observations must be consecutive. |
| Secondary | PFS Rate According to WHO Response Criteria at 18 Weeks From Start of R1507 Treatment in Cohorts 2 to 8 | Baseline, every 6 weeks until disease progression (up to 18 weeks) | The PFS survival rate is a landmark analysis of progression-free survival at 18 weeks from start of treatment. Progression-free survival rate at 18 weeks is a dichotomous endpoint, with a patient categorized as alive (with either stable disease or objective response at 18 weeks) from start of treatment. |
| Secondary | Percentage of Participants With AEs in Cohorts 3-8 | Baseline up to 6 years | |
| Secondary | Duration of Response (DOR) According to WHO Response Criteria in Cohorts 1 to 8 | Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years) | The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Complete response is the disappearance of all known disease, determined by two consecutive observations not less than 4 weeks apart. Partial response is \>=50% decrease in the total tumor load of the lesions that have been measured to determine the effect of therapy not less than four weeks apart. The observations must be consecutive. |
| Secondary | Time to Progression (TTP) According to WHO Response Criteria in Cohorts 1 to 8 | Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years) | TTP is defined as the time from date of randomization until objective tumor progression. According to the WHO Response Criteria, objective tumor progression is \> 25% increase in the area of one or more measurable lesions or the appearance of new lesions. |
| Secondary | Failure-Free Survival (FFS) According to WHO Response Criteria in Cohorts 1 to 8 | Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years) | FFS was measured from the date of treatment start to the date of documented disease progression, relapse, or death from any cause. |
| Secondary | Overall Survival (OS) in Cohorts 1 to 8 | Baseline until death (up to 6 years) | OS was measured from the time of study registration to the date of death or was censored at the date of last contact. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Complete or Partial Response, According to World Health Organization (WHO) Criteria in Cohorts 2 to 8 | Baseline up to 6 years (assessed at baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression) | ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment. There were 0 participants analyzed for Cohort 3 due to no efficacy data being collected for that cohort. | Percentage of Participants | NUMBER |
| PRIMARY | Progression-Free Survival (PFS) Rate According to WHO Response Criteria at 18 Weeks From Start of R2607 Treatment in Cohort 1 | Baseline up to 18 weeks (assessed at baseline, every 6 weeks until disease progression) | ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Adverse Events (AEs) in Cohort 1 and 2 | Baseline up to 6 years | Safety Population: All participants who received at least one dose of study drug at had at least one safety follow-up assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Complete or Partial Response According to WHO Response Criteria in Cohort 1 | Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years) | ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment. | percentage of participants | NUMBER |
| SECONDARY | PFS Rate According to WHO Response Criteria at 18 Weeks From Start of R1507 Treatment in Cohorts 2 to 8 | Baseline, every 6 weeks until disease progression (up to 18 weeks) | ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment. There were 0 participants analyzed for Cohort 3 due to no efficacy data being collected for that cohort. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With AEs in Cohorts 3-8 | Baseline up to 6 years | Safety Population: All participants who received at least one dose of study drug at had at least one safety follow-up assessment. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) According to WHO Response Criteria in Cohorts 1 to 8 | Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years) | ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment. There were 0 participants analyzed for Cohort 3, 7 and 8 due to no DOR data being collected for these cohorts. | weeks | MEDIAN |
| SECONDARY | Time to Progression (TTP) According to WHO Response Criteria in Cohorts 1 to 8 | Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years) | ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment. There were 0 participants analyzed for Cohort 3 due to no efficacy data being collected for that cohort. | weeks | MEDIAN |
| SECONDARY | Failure-Free Survival (FFS) According to WHO Response Criteria in Cohorts 1 to 8 | Baseline, every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 6 years) | Data was not collected for this endpoint. | ||
| SECONDARY | Overall Survival (OS) in Cohorts 1 to 8 | Baseline until death (up to 6 years) | ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment. There were 0 participants analyzed for Cohort 3 and 7c due to no overall survival data being collected for those cohorts. | weeks | MEDIAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Complete or Partial Response, According to World Health Organization (WHO) Criteria in Cohorts 2 to 8 | Cohort 2: Ewings Sarcoma Secondary Cohort | 11.11 | Percentage of Participants | ||
| Percentage of Participants With Complete or Partial Response, According to World Health Organization (WHO) Criteria in Cohorts 2 to 8 | Cohort 4: Osteosarcoma | 2.5 | Percentage of Participants | ||
| Percentage of Participants With Complete or Partial Response, According to World Health Organization (WHO) Criteria in Cohorts 2 to 8 | Cohort 5: Synovial Sarcoma | 4.0 | Percentage of Participants | ||
| Percentage of Participants With Complete or Partial Response, According to World Health Organization (WHO) Criteria in Cohorts 2 to 8 | Cohort 6: Rhabdomyosarcoma | 4.88 | Percentage of Participants | ||
| Percentage of Participants With Complete or Partial Response, According to World Health Organization (WHO) Criteria in Cohorts 2 to 8 | Cohort 7a: Alveolar Soft Part Sarcoma | 0 | Percentage of Participants | ||
| Percentage of Participants With Complete or Partial Response, According to World Health Organization (WHO) Criteria in Cohorts 2 to 8 | Cohort 7b: Desmoplastic Small Round Cell Tumors. | 0 | Percentage of Participants | ||
| Percentage of Participants With Complete or Partial Response, According to World Health Organization (WHO) Criteria in Cohorts 2 to 8 | Cohort 7c: Extraskeletal Myxoid Chondrosarcoma | 0 | Percentage of Participants | ||
| Percentage of Participants With Complete or Partial Response, According to World Health Organization (WHO) Criteria in Cohorts 2 to 8 | Cohort 7d: Clear Cell Sarcoma | 0 | Percentage of Participants | ||
| Percentage of Participants With Complete or Partial Response, According to World Health Organization (WHO) Criteria in Cohorts 2 to 8 | Cohort 7e: Myxoid Liposarcoma | 0 | Percentage of Participants | ||
| Percentage of Participants With Complete or Partial Response, According to World Health Organization (WHO) Criteria in Cohorts 2 to 8 | Cohort 8: Diagnosis Not Specified | 0 | Percentage of Participants |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: Ewings Sarcoma Primary Cohort | 70 | |
| Overall Study | STARTED | Cohort 2: Ewings Sarcoma Secondary Cohort | 54 | |
| Overall Study | STARTED | Cohort 3: Ewings Sarcoma Expanded Cohort | 7 | |
| Overall Study | STARTED | Cohort 4: Osteosarcoma | 40 | |
| Overall Study | STARTED | Cohort 5: Synovial Sarcoma | 25 | |
| Overall Study | STARTED | Cohort 6: Rhabdomyosarcoma | 41 | |
| Overall Study | STARTED | Cohort 7a: Alveolar Soft Part Sarcoma | 23 | |
| Overall Study | STARTED | Cohort 7b: Desmoplastic Small Round Cell Tumors. | 14 | |
| Overall Study | STARTED | Cohort 7c: Extraskeletal Myxoid Chondrosarcoma | 11 | |
| Overall Study | STARTED | Cohort 7d: Clear Cell Sarcoma | 9 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events2,880
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 | Alanine aminotransferase increased | Investigations | Cohort 1: Ewings Sarcoma Primary Cohort | 5 | 70 | |
| other | Alanine aminotransferase increased | Investigations | Cohort 2: Ewings Sarcoma Secondary Cohort | 2 | 54 | |
| other | Alanine aminotransferase increased | Investigations | Cohort 3: Ewings Sarcoma Expanded Cohort | 1 | 7 | |
| other | Alanine aminotransferase increased | Investigations | Cohort 4: Osteosarcoma | 2 | 40 | |
| other | Alanine aminotransferase increased | Investigations | Cohort 5: Synovial Sarcoma | 3 | 25 | |
| other | Alanine aminotransferase increased | Investigations | Cohort 6: Rhabdomyosarcoma | 7 | 41 | |
| other | Alanine aminotransferase increased | Investigations | Cohort 7a: Alveolar Soft Part Sarcoma | 2 | 23 | |
| other | Alanine aminotransferase increased | Investigations | Cohort 7b: Desmoplastic Small Round Cell Tumors | 2 | 14 | |
| other | Alanine aminotransferase increased | Investigations | Cohort 7c: Extraskeletal Myxoid Chondrosarcoma | 0 | 11 | |
| other | Alanine aminotransferase increased | Investigations | Cohort 7d: Clear Cell Sarcoma | 0 | 9 |
1 to 10 of 2,880Source ClinicalTrials.gov
See all 2,880 adverse eventsAdverse event totals36
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: Ewings Sarcoma Primary Cohort | 9 | 70 |
| Total, all-cause mortality | Cohort 2: Ewings Sarcoma Secondary Cohort | 5 | 54 |
| Total, all-cause mortality | Cohort 3: Ewings Sarcoma Expanded Cohort | 2 | 7 |
| Total, all-cause mortality | Cohort 4: Osteosarcoma | 7 | 40 |
| Total, all-cause mortality | Cohort 5: Synovial Sarcoma | 3 | 25 |
| Total, all-cause mortality | Cohort 6: Rhabdomyosarcoma | 3 | 41 |
| Total, all-cause mortality | Cohort 7a: Alveolar Soft Part Sarcoma | 1 | 23 |
| Total, all-cause mortality | Cohort 7b: Desmoplastic Small Round Cell Tumors | 0 | 14 |
| Total, all-cause mortality | Cohort 7c: Extraskeletal Myxoid Chondrosarcoma | 0 | 11 |
| Total, all-cause mortality | Cohort 7d: Clear Cell Sarcoma | 1 | 9 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT00642941
GET https://conductscience.org/api/trials/v1/NCT00642941/results?page=2