NCT02523014ClinicalTrials.gov
Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas
Phase II Trial of SMO/ AKT/ NF2/CDK Inhibitors in Progressive Meningiomas With SMO/ AKT/ NF2/CDK Pathway Mutations
En bref
This phase II trial studies how well vismodegib, focal adhesion kinase (FAK) inhibitor GSK2256098, and capivasertib work in treating patients with meningioma that is growing, spreading, or getting worse (progressive). Vismodegib, FAK inhibitor GSK2256098, capivasertib, and abemaciclib may stop the…
Phase 2124 participants recherchés783 sites1 pays
Catégories
Enregistré dans 1 registre
- ClinicalTrials.govNCT02523014Ouvrir cette fiche sur ClinicalTrials.govSynchronisé il y a 3 semaines
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How this study is set up
The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.
- Present: Registered before enrolment beganFirst posted 2015-08-14; recorded start 2015-09-28
- Present: Has a defined primary outcomeA primary outcome measure is listed in the record
- Present: The primary outcome states a time frameThe primary outcome measure records a time frame
- Not stated: Participants are not randomly assignedAllocation is recorded as non-randomised
- Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
- Not stated: Open label (no blinding)Masking is recorded as none (open label)
- Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
- Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
- Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
- Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
- Present: Sponsor has 95 other studies in this databaseCounted from the lead sponsor named in the record (Alliance for Clinical Trials in Oncology)
- Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
- The record lists 3 conditions.
- Lead sponsor type recorded as: other.
- Intervention regulatory context: investigational, within a phased regulatory pathway.
Trial stature
Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.
A moderately rigorous design for a phase 2 study, judged from its ClinicalTrials.gov record.
How this score is built
- Randomised allocation0/20
Non-randomised allocation
- Blinding0/20
Open-label
- Control arm0/15
No comparator arm stated in the record
- Primary-outcome specificity10/10
Named primary outcome with a defined time frame
- Endpoint type10/10
Mortality / MACE endpoint (hard clinical outcome)
- Multi-centre8/8
Multi-centre: 780 sites
- Data monitoring committee7/7
A data monitoring committee is in place
- Prospective registration5/5
Registered before the study start date
- Protocol / SAP posted0/5
No protocol or SAP posted to the registry
A small study: 124 participants (target), run at 783 sites.
How this score is built
- Enrolment20/40
124 participants (target)
- Site count25/25
780 sites
- Country count0/15
Single country
- Planned duration10/10
Planned over about 149 months
- Sponsor scale7/10
Alliance for Clinical Trials in Oncology has led 96 trials in our corpus
We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.
How this score is built
- Investigator standing0/100
No investigator recorded in the registry for this trial
These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.
Résumé
This phase II trial studies how well vismodegib, focal adhesion kinase (FAK) inhibitor GSK2256098, and capivasertib work in treating patients with meningioma that is growing, spreading, or getting worse (progressive). Vismodegib, FAK inhibitor GSK2256098, capivasertib, and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Affections
- Intracranial Meningioma
- Recurrent Meningioma
- NF2 Gene Mutation
Éligibilité
| Sexe | Tous |
|---|---|
| Âges | 18 Years – Aucun maximum |
| Volontaires sains | Non |
Éligibilité telle qu'elle figure dans le registre
Éligibilité en énoncés simples
Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.
Conception de l'étude
| Type d'étude | Interventionnelle |
|---|---|
| Phase | Phase 2 |
| Répartition | Non randomisée |
| Modèle d'intervention | PARALLEL |
| Objectif principal | TREATMENT |
| Insu | NONE (0) |
| Recrutement | 124 participants recherchés |
Promoteur et collaborateurs
- Alliance for Clinical Trials in Oncology Promoteur
- National Cancer Institute (NCI) Collaborateurs
- GlaxoSmithKline Collaborateurs
- Genentech, Inc. Collaborateurs
- Brain Science Foundation Collaborateurs
Groupes et interventions
- Arm A (vismodegib)EXPERIMENTAL
Patients receive vismodegib PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL FEBRUARY 2018)
- Arm B (FAK inhibitor GSK2256098)EXPERIMENTAL
Patients receive FAK inhibitor GSK2256098 PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL JULY 2017)
- Arm C (capivasertib)EXPERIMENTAL
Patients receive capivasertib PO BID on days 1-4. Treatment repeats every 7 days for up to 1 cycle (28 days) in the absence of disease progression or unacceptable toxicity.
- Arm D (abemaciclib)EXPERIMENTAL
Patients receive abemaciclib PO Q12H. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions
- Médicament Abemaciclib
Given PO
- Médicament Capivasertib
Given PO
- Médicament FAK Inhibitor GSK2256098
Given PO
- Médicament Vismodegib
Given PO
Critères de jugement
Critère de jugement principal
Progression free survival (PFS)
Point estimates and 95% binomial confidence intervals will be generated for the six month PFS rate within each cohort of each treatment arm. Kaplan-Meier curves will be generated for PFS for each cohort within each treatment arm.
Délai At 6 months
Critère de jugement principal
Response rate defined as a confirmed complete response (CR) or partial response (PR)
Point estimates will be generated for response rates within each treatment arm with corresponding 95% binomial confidence intervals.
Délai Up to 2 years
Critère de jugement secondaire
Overall survival (OS)
OS will be summarized for each cohort within each treatment group with Kaplan-Meier curves and estimates.
Délai Up to 2 years
Critère de jugement secondaire
Incidence of adverse events according to National Cancer Institute CTCAE version 4.0
Adverse events (AEs) will be summarized for each treatment group. They will be summarized as the number and frequency of each event. In addition the AEs will be summarized as the number and frequency of patients who experience any AE, AEs of grade 3+, and AEs of grade 4+.
Délai Up to 4 weeks after completion of study treatment
Dates
| Date de début | 28 septembre 2015 (réelle) |
|---|---|
| Achèvement principal | 1 janvier 2027 (estimée) |
| Achèvement | 1 janvier 2028 (estimée) |
| Première publication | 14 août 2015 (estimée) |
| Dernière mise à jour | 2 septembre 2026 |
| Résultats publiés | Non précisé dans la fiche du registre |
| Statut vérifié pour la dernière fois | septembre 2026 |
Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.
Lieux
448 sites sont en recrutement
United States
| Établissement | Ville | État ou région | Statut |
|---|---|---|---|
| Providence Regional Cancer System-Aberdeen | Aberdeen | Washington | En recrutement |
| Riverwood Healthcare Center | Aitkin | Minnesota | En recrutement |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | En recrutement |
| Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania | En recrutement |
| MyMichigan Medical Center Gratiot | Alma | Michigan | En recrutement |
| MyMichigan Medical Center Alpena | Alpena | Michigan | En recrutement |
| OSF Saint Anthony's Health Center | Alton | Illinois | En recrutement |
| McFarland Clinic - Ames | Ames | Iowa | Actif, sans recrutement |
| Mary Greeley Medical Center | Ames | Iowa | Actif, sans recrutement |
| Cancer Care Center at Island Hospital | Anacortes | Washington | Suspendu |
| Anchorage Oncology Centre | Anchorage | Alaska | Suspendu |
| Anchorage Associates in Radiation Medicine | Anchorage | Alaska | En recrutement |
| Alaska Women's Cancer Care | Anchorage | Alaska | En recrutement |
| Alaska Oncology and Hematology LLC | Anchorage | Alaska | En recrutement |
| Alaska Breast Care and Surgery LLC | Anchorage | Alaska | En recrutement |
| Anchorage Radiation Therapy Center | Anchorage | Alaska | Suspendu |
| Katmai Oncology Group | Anchorage | Alaska | En recrutement |
| Providence Alaska Medical Center | Anchorage | Alaska | En recrutement |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic | Ankeny | Iowa | En recrutement |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor | Ann Arbor | Michigan | En recrutement |
| Kaiser Permanente-Deer Valley Medical Center | Antioch | California | Actif, sans recrutement |
| Mission Hope Medical Oncology - Arroyo Grande | Arroyo Grande | California | En recrutement |
| PCR Oncology | Arroyo Grande | California | En recrutement |
| AdventHealth Infusion Center Asheville | Asheville | North Carolina | Actif, sans recrutement |
| Northwest Wisconsin Cancer Center | Ashland | Wisconsin | En recrutement |
| Duluth Clinic Ashland | Ashland | Wisconsin | En recrutement |
| Grady Health System | Atlanta | Georgia | En recrutement |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | En recrutement |
| Piedmont Hospital | Atlanta | Georgia | En recrutement |
| Emory University Hospital Midtown | Atlanta | Georgia | En recrutement |
| Sutter Auburn Faith Hospital | Auburn | California | Actif, sans recrutement |
| Sutter Cancer Centers Radiation Oncology Services-Auburn | Auburn | California | Actif, sans recrutement |
| Rush-Copley Medical Center | Aurora | Illinois | En recrutement |
| UCHealth University of Colorado Hospital | Aurora | Colorado | En recrutement |
| Dell Seton Medical Center at The University of Texas | Austin | Texas | Actif, sans recrutement |
| Mount Sinai Comprehensive Cancer Center at Aventura | Aventura | Florida | Actif, sans recrutement |
| Saint Alphonsus Cancer Care Center-Baker City | Baker City | Oregon | En recrutement |
| Mercy Oncology and Hematology - Clayton-Clarkson | Ballwin | Missouri | En recrutement |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | Actif, sans recrutement |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | En recrutement |
| CommonSpirit Saint Joseph Hospital - Bardstown | Bardstown | Kentucky | En recrutement |
| Advocate Good Shepherd Hospital | Barrington | Illinois | En recrutement |
| Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | Actif, sans recrutement |
| Bronson Battle Creek | Battle Creek | Michigan | En recrutement |
| Essentia Health - Baxter Clinic | Baxter | Minnesota | En recrutement |
| UPMC-Heritage Valley Health System Beaver | Beaver | Pennsylvania | Actif, sans recrutement |
| Indu and Raj Soin Medical Center | Beavercreek | Ohio | Actif, sans recrutement |
| Overlake Medical Center | Bellevue | Washington | Suspendu |
| Nebraska Medicine-Bellevue | Bellevue | Nebraska | Actif, sans recrutement |
| PeaceHealth Saint Joseph Medical Center | Bellingham | Washington | En recrutement |
733 sites supplémentaires sont indiqués dans la fiche du registre.
Documents de l'étude
Aucun document n'est lié dans cette fiche du registre.
Évolution au fil du temps
- 5 août 2026
Site ajouté
3 sites added (783 total)
780783