Terminated PHASE1/PHASE2 INTERVENTIONAL 3-arm NCT01601184

Study of Vismodegib in Combination With Temozolomide Versus Temozolomide Alone in Patients With Medulloblastomas With an Activation of the Sonic Hedgehog Pathway

An International, Randomized, Open-label Phase I/II Study of Vismodegib in Combination With Temozolomide Versus Temozolomide Alone in Adult Patients With Recurrent or Refractory Medulloblastomas Presenting an Activation of the Sonic Hedgehog (SHH) Pathway

Sponsor: Centre Leon Berard

Conditions Activation of the Sonic Hedgehog (SHH) Pathway Histologically Confirmed Medulloblastoma

Interventions Temozolomide vismodegib

Updated 10 times since 2017 Last updated: May 20, 2019 Started: Jun 30, 2012 Primary completion: Sep 30, 2017 Completion: Oct 31, 2017

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

The number of successes is not reached at the end of first stage of the phase II. The study is stopped.

Other terminated trials from Centre Leon Berard

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This PHASE1/PHASE2 trial investigates Activation of the Sonic Hedgehog (SHH) Pathway and Histologically Confirmed Medulloblastoma and is currently terminated or withdrawn. Centre Leon Berard leads this study, which shows 10 recorded versions since 2012 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

10 versions recorded

Sep 2025 — Present [monthly]

Terminated PHASE1/PHASE2
Sep 2024 — Sep 2025 [monthly]

Terminated PHASE1/PHASE2
Jul 2024 — Sep 2024 [monthly]

Terminated PHASE1/PHASE2

Phase: PHASE1_PHASE2 → PHASE1/PHASE2
Dec 2021 — Jul 2024 [monthly]

Terminated PHASE1_PHASE2
Jan 2021 — Dec 2021 [monthly]

Terminated PHASE1_PHASE2

▶ Show 5 earlier versions

Nov 2020 — Jan 2021 [monthly]

Terminated PHASE1_PHASE2
Jun 2019 — Nov 2020 [monthly]

Terminated PHASE1_PHASE2
Oct 2018 — Jun 2019 [monthly]

Terminated PHASE1_PHASE2

Status: Recruiting → Terminated
Jun 2018 — Oct 2018 [monthly]

Recruiting PHASE1_PHASE2
Jan 2017 — Jun 2018 [monthly]

Recruiting PHASE1_PHASE2

First recorded

Jun 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Centre Leon Berard
Ministry of Health, France

Data source: Centre Leon Berard

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Angers, France , Bologna, Italy , Bordeaux, France , Lausanne, Switzerland , Lille, France , London, United Kingdom , Lorient, France , Lyon, France , Marseille, France , Nancy, France and 5 more locations