Trial · NCT02813135
European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors
NCT02813135, Phase 1, Phase 2, Recruiting, Gustave Roussy, Cancer Campus, Grand Paris
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors. Trials, record NCT02813135. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02813135
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors
- NCT number
- NCT02813135
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 472 participants, estimated
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Conditions
- Pediatric Cancer
- Interventions
Ribociclib, Topotecan, Temozolomide, Everolimus, Adavosertib, Carboplatin, Olaparib, Irinotecan, Vistusertib, Nivolumab, Cyclophosphamide, Selumetinib, Enasidenib, Lirilumab, Fadraciclib, Cytarabine, Dexamethasone, Ceralasertib, Futibatinib, Capmatinib, Avelumab, Peposertib, Capivasertib, Vinorelbine
- First posted
- 2016-06-24
- Last updated
- 2026-07-10
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended phase II dose (RP2D) | During the first cycle | Defined as the adult recommended dose (adjusted for weight or BSA) if toxicity and/or PK profiling are similar in children and in adults, or a higher dose, providing it is below or equal to the maximum tolerated dose (MTD) |
| Primary | Maximum Tolerated Dose (MTD) | During the first cycle | The MTD will be defined as the dose associated with or closest to 25% of Dose Limiting Toxicities (DLTs) |
| Primary | Objective Response Rate (ORR) | During treatment period | Defined as the proportion of participants who achieved a confirmed complete response (CR) or partial response (PR) assessed by investigators. In patients with leukemia, ORR is defined as the percentage of patients attaining CR, CRi or CRp. |
| Secondary | Pharmacokinetics (PK) | Depending on the treatment arm | To characterize single or multiple-dose PK of the agent(s) |
| Secondary | Progression Free Survival (PFS) | From treatment initiation until the date of first documented progression or death | Defined as the time from treatment initiation until the date of first documented progression (clinically or radiologically) or death from any cause. Patients alive and free of progression at the cut-off date will be censored at the last assessment date. |
| Secondary | Evaluation of duration of response (DoR) | Between the first document response and the time of first documented progression | Defined as the time period between the first documented response (complete response (CR) or partial response (PR)) and the time of progression, according to RECIST v1.1, RANO criteria for patients with HGG, INRC criteria for patients with NB, etc. |
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.
Papers7
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/NCT02813135
GET https://conductscience.org/api/trials/v1/NCT02813135/registered