Trial · NCT01830504
A Multicenter Phase II Pilot Open Label
NCT01830504, Phase 2, Unknown, Hospices Civils de Lyon
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Multicenter Phase II Pilot Open Label. Trials, record NCT01830504. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01830504
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multicenter Phase II Pilot Open Label
- NCT number
- NCT01830504
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 47 participants, actual
- Lead sponsor
- Hospices Civils de Lyon
- Conditions
- Thyroid Cancers
- Interventions
- BKM120
- First posted
- 2013-04-12
- Last updated
- 2016-10-05
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | progression-free survival (PFS) | at 6 months after the onset of the treatment | The progression-free survival is defined as a lack of objective tumor progression and death. Tumor progression is documented by the CT or MRI scans. Progression is defined according to RECIST criteria (version 1.1.). |
| Secondary | progression-free survival (PFS) | PFS at 12 months after the onset of the treatment | |
| Secondary | Objective tumor response (CR and PR) | at 6 months after the onset of the treatment | according to RECIST criteria (version 1.1.) and validated by a central review committee. |
| Secondary | Overall survival | at 6 months after the onset of the treatment | Overall survival (defined as the time from start of study treatment to the date of death due to any cause) |
| Secondary | safety and tolerance of BKM120 of BKM120: monitoring and recording AE and SAE, monitoring of hematology, blood chemistry and urine values, vital signs, physical examinations, skin, cardiac assessments and mood evaluation. | After the patient has provided informed consent and until 4 weeks after the patient has stopped study participation. Assessments are performed at least every month during the first year, every 3 month until 12 months and every 4 months after this period. | Safety and tolerability will be assessed according to the NIH/NCI CTC (V4.0). Care will be taken to the monitoring of haematology, kidney function, liver function, endocrin/metabolic function, cardiac function, mood and rash evaluation. Blood chemistry and urine will be considered. The others assessment will be: physical examination, ECOG performance status, body weight, vital signs, PHQ9 and GAD7 questionnaires, ECG and CT or MRI scans. For patients who do not tolerate the protocol-specified dosing schedule, dose modification and/or dose interruption are permitted. |
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 |
|---|---|
| 30105951 | 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/NCT01830504
GET https://conductscience.org/api/trials/v1/NCT01830504/registered