Trial · NCT02115074
Safety of Fluvastatin-Celebrex Association in Low-grade and High Grade Optico-chiasmatic Gliomas
NCT02115074, Phase 1, Completed, Centre Oscar Lambret
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety of Fluvastatin-Celebrex Association in Low-grade and High Grade Optico-chiasmatic Gliomas. Trials, record NCT02115074. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02115074
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety of Fluvastatin-Celebrex Association in Low-grade and High Grade Optico-chiasmatic Gliomas
- NCT number
- NCT02115074
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 20 participants, actual
- Lead sponsor
- Centre Oscar Lambret
- Conditions
- Glioma
- Interventions
- Fluvastatine, Celebrex
- First posted
- 2014-04-15
- Last updated
- 2026-03-18
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose (MTD) of Fluvastatine combined to a fixed-dose of Celebrex | 28 days (at the end of the first cycle) | The MTD is evaluated according to NCI-CTC v4.0 scale, and is defined as follows: * grade 3 or 4 neutropenia leading to a delay of therapy superior to 7 days * grade 3 or 4 thrombocytopenia requiring transfusions over a period superior to 7 days * grade 3 or 4 non-hematologic toxicities, excepted the following events: * nausea and vomiting despite appropriate symptomatic treatment, * grade 3 fever, and grade 3 liver toxicity but rapidly reversible, * grade 3 elevation of creatine phosphokinase (CPK) levels, but rapidly reversible (back \<3 X normal within 2 weeks after interruption of treatment) * Toxicity leading to dose reduction (\<75% dose protocol) will also be considered as a DLT, although the grade of toxicity does not in itself justify this classification |
| Secondary | Adverse events | During all the treatment period, for up to 1 year | Safety is assessed according to NCI-CTC v4.0 scale |
| Secondary | Efficacy in terms of overall survival | From date of registration until the date of death from any cause, assessed up to 2 years | Efficacy is measured according to RANO criteria |
| Secondary | Efficacy in terms of progression-free survival | After 3, 6, 9 and 12 months of treatment | Efficacy is measured according to RANO criteria. |
| Secondary | Potential interactions between the two drugs | Pharmacokinetics: 1 blood sample of 1.5 ml is collected during cycle 1 and at day 1 of the second cycle before fluvastatine and celebrex administration. | The Fluvastatin and Celebrex are dosed on the same sample, then compared with pharmacokinetics data from the literature (when drugs are administered alone). The objective is to explore the interaction between the 2 drugs. Pharmacokinetic analysis is performed by liquid chromatography coupled to mass spectrometry (LC/MS), with UV detection. |
| Secondary | Best response' s distribution during the treatment | After 3, 6, 9 and 12 months of treatment | Best response is measured according to RANO 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.
Papers0
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/NCT02115074
GET https://conductscience.org/api/trials/v1/NCT02115074/registered