Trial · NCT01587040
Open Label Treatment Extension Study With SAR245408 or SAR245409 as a Monotherapy or as a Combination Regimen
NCT01587040, Phase 1, Phase 2, Completed, Sanofi; results first posted 2019-06-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open Label Treatment Extension Study With SAR245408 or SAR245409 as a Monotherapy or as a Combination Regimen. Trials, record NCT01587040. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01587040
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open Label Treatment Extension Study With SAR245408 or SAR245409 as a Monotherapy or as a Combination Regimen
- NCT number
- NCT01587040
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 61 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Neoplasm Malignant
- Interventions
- SAR245408, SAR245409
- First posted
- 2012-04-27
- Last updated
- 2022-04-19
- Other registries' IDs
- eudract:2011-006140-78
- Results first posted
- 2019-06-11
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From Baseline up to 30 days after the last dose (maximum exposure: 1959 days) | Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. Serious adverse event (SAE): any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial/prolonged in-patient hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAEs: AEs that developed/worsened/became serious during on-treatment period (time from IMP until 30 days after last dose of any IMP). Any TEAE included participants with both SAE \& non-SAEs. TEAE included participants with any treatment-emergent SAE (TESAE). TEAEs that led to death, dose reduction and/or delay, discontinuation \& AEs related to treatment were reported. Grades (3=severe, 4=life-threatening/disabling) represents severity of AEs. |
| Primary | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | From Baseline up to 30 days after the last dose (maximum exposure: 1959 days) | Hematological parameters assessed were anemia, neutropenia and thrombocytopenia. Parameters were assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Experience version 4.03 (NCI-CTCAE v 4.03), where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. |
| Primary | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | From Baseline up to 30 days after the last dose (maximum exposure: 1959 days) | Biochemical parameters assessed were hyperglycemia, aspartate aminotransferase (ASAT) increased, alanine aminotransferase (ALAT) increased, hyperbilirubinemia, hypocalcemia, creatinine increased. Parameters were assessed as per the NCI-CTCAE v 4.03, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From Baseline up to 30 days after the last dose (maximum exposure: 1959 days) | Analysis was performed on safety population that included all participants who took at least 1 dose of study drug during the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters | From Baseline up to 30 days after the last dose (maximum exposure: 1959 days) | Analysis was performed on safety population. Here, Overall number of participants analyzed = participants with available data for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters | From Baseline up to 30 days after the last dose (maximum exposure: 1959 days) | Analysis was performed on safety population. Here, number analyzed= participants with available data for specified category. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group228
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | SAR245408: Monotherapy | Any TEAE | 16 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | SAR245408: Combination Regimen | Any TEAE | 3 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | SAR245409: Monotherapy | Any TEAE | 35 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | SAR245409: Combination Regimen | Any TEAE | 3 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | SAR245408: Monotherapy | Any Grade 3-4 TEAEs | 12 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | SAR245408: Combination Regimen | Any Grade 3-4 TEAEs | 2 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | SAR245409: Monotherapy | Any Grade 3-4 TEAEs | 19 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | SAR245409: Combination Regimen | Any Grade 3-4 TEAEs | 1 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | SAR245408: Monotherapy | Any related TEAEs | 12 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | SAR245408: Combination Regimen | Any related TEAEs | 3 | Participants |
1 to 10 of 228Source ClinicalTrials.gov
See all 228 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SAR245408: Monotherapy | 17 | |
| Overall Study | STARTED | SAR245408: Combination Regimen | 3 | |
| Overall Study | STARTED | SAR245409: Monotherapy | 37 | |
| Overall Study | STARTED | SAR245409: Combination Regimen | 4 | |
| Overall Study | COMPLETED | SAR245408: Monotherapy | 0 | |
| Overall Study | COMPLETED | SAR245408: Combination Regimen | 0 | |
| Overall Study | COMPLETED | SAR245409: Monotherapy | 0 | |
| Overall Study | COMPLETED | SAR245409: Combination Regimen | 0 | |
| Overall Study | NOT COMPLETED | SAR245408: Monotherapy | 17 | |
| Overall Study | NOT COMPLETED | SAR245408: Combination Regimen | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,404
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 | SAR245408: Monotherapy | 3 | 17 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | SAR245408: Combination Regimen | 1 | 3 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | SAR245409: Monotherapy | 2 | 37 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | SAR245409: Combination Regimen | 0 | 4 | 0 |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | SAR245408: Monotherapy | 1 | 17 | 1 |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | SAR245408: Combination Regimen | 0 | 3 | 0 |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | SAR245409: Monotherapy | 0 | 37 | 0 |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | SAR245409: Combination Regimen | 0 | 4 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | SAR245408: Monotherapy | 0 | 17 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | SAR245408: Combination Regimen | 0 | 3 | 0 |
1 to 10 of 1,404Source ClinicalTrials.gov
See all 1,404 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SAR245408: Monotherapy | 1 | 17 |
| Total, all-cause mortality | SAR245408: Combination Regimen | 0 | 3 |
| Total, all-cause mortality | SAR245409: Monotherapy | 3 | 37 |
| Total, all-cause mortality | SAR245409: Combination Regimen | 0 | 4 |
| Total, other adverse events | SAR245408: Monotherapy | 15 | 17 |
| Total, other adverse events | SAR245408: Combination Regimen | 3 | 3 |
| Total, other adverse events | SAR245409: Monotherapy | 34 | 37 |
| Total, other adverse events | SAR245409: Combination Regimen | 3 | 4 |
| Total, serious adverse events | SAR245408: Monotherapy | 9 | 17 |
| Total, serious adverse events | SAR245408: Combination Regimen | 1 | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT01587040
GET https://conductscience.org/api/trials/v1/NCT01587040/results?page=2