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
باختصار
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…
المرحلة 2مطلوب 124 مشاركاً783 موقعاًدولة واحدة
الفئات
مسجَّلة في سجل واحد
- ClinicalTrials.govNCT02523014فتح هذا السجل في ClinicalTrials.govتمت المزامنة قبل 3 أسابيع
يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.
تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.
هل أنت مهتم بهذه الدراسة؟
تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.
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.
ملخص
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.
الحالات
- Intracranial Meningioma
- Recurrent Meningioma
- NF2 Gene Mutation
الأهلية
| الجنس | الجميع |
|---|---|
| الأعمار | 18 Years – لا حد أقصى |
| المتطوعون الأصحّاء | لا |
الأهلية كما كُتبت في السجل
الأهلية في عبارات بسيطة
لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.
تصميم الدراسة
| نوع الدراسة | تدخّلية |
|---|---|
| المرحلة | المرحلة 2 |
| التخصيص | غير معشّاة |
| نموذج التدخّل | PARALLEL |
| الغرض الأساسي | TREATMENT |
| التعمية | NONE (0) |
| التجنيد | مطلوب 124 مشاركاً |
الجهة الراعية والمتعاونون
- Alliance for Clinical Trials in Oncology الجهة الراعية
- National Cancer Institute (NCI) المتعاونون
- GlaxoSmithKline المتعاونون
- Genentech, Inc. المتعاونون
- Brain Science Foundation المتعاونون
الأذرع والتدخلات
- 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.
التدخلات
- دواء Abemaciclib
Given PO
- دواء Capivasertib
Given PO
- دواء FAK Inhibitor GSK2256098
Given PO
- دواء Vismodegib
Given PO
مقاييس النتائج
مقياس النتيجة الأولي
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.
الإطار الزمني At 6 months
مقياس النتيجة الأولي
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.
الإطار الزمني Up to 2 years
مقياس النتيجة الثانوي
Overall survival (OS)
OS will be summarized for each cohort within each treatment group with Kaplan-Meier curves and estimates.
الإطار الزمني Up to 2 years
مقياس النتيجة الثانوي
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+.
الإطار الزمني Up to 4 weeks after completion of study treatment
التواريخ
| تاريخ البدء | 28 سبتمبر 2015 (فعلي) |
|---|---|
| الإتمام الأولي | 1 يناير 2027 (تقديري) |
| الإتمام | 1 يناير 2028 (تقديري) |
| أول نشر | 14 أغسطس 2015 (تقديري) |
| آخر تحديث | 2 سبتمبر 2026 |
| النتائج منشورة | غير مذكور في سجل السجل |
| آخر تأكيد للحالة | سبتمبر 2026 |
فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.
المواقع
448 موقعاً قيد التجنيد
United States
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Providence Regional Cancer System-Aberdeen | Aberdeen | Washington | قيد التجنيد |
| Riverwood Healthcare Center | Aitkin | Minnesota | قيد التجنيد |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | قيد التجنيد |
| Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania | قيد التجنيد |
| MyMichigan Medical Center Gratiot | Alma | Michigan | قيد التجنيد |
| MyMichigan Medical Center Alpena | Alpena | Michigan | قيد التجنيد |
| OSF Saint Anthony's Health Center | Alton | Illinois | قيد التجنيد |
| McFarland Clinic - Ames | Ames | Iowa | نشط، دون تجنيد |
| Mary Greeley Medical Center | Ames | Iowa | نشط، دون تجنيد |
| Cancer Care Center at Island Hospital | Anacortes | Washington | مُعلَّق |
| Anchorage Oncology Centre | Anchorage | Alaska | مُعلَّق |
| Anchorage Associates in Radiation Medicine | Anchorage | Alaska | قيد التجنيد |
| Alaska Women's Cancer Care | Anchorage | Alaska | قيد التجنيد |
| Alaska Oncology and Hematology LLC | Anchorage | Alaska | قيد التجنيد |
| Alaska Breast Care and Surgery LLC | Anchorage | Alaska | قيد التجنيد |
| Anchorage Radiation Therapy Center | Anchorage | Alaska | مُعلَّق |
| Katmai Oncology Group | Anchorage | Alaska | قيد التجنيد |
| Providence Alaska Medical Center | Anchorage | Alaska | قيد التجنيد |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic | Ankeny | Iowa | قيد التجنيد |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor | Ann Arbor | Michigan | قيد التجنيد |
| Kaiser Permanente-Deer Valley Medical Center | Antioch | California | نشط، دون تجنيد |
| Mission Hope Medical Oncology - Arroyo Grande | Arroyo Grande | California | قيد التجنيد |
| PCR Oncology | Arroyo Grande | California | قيد التجنيد |
| AdventHealth Infusion Center Asheville | Asheville | North Carolina | نشط، دون تجنيد |
| Northwest Wisconsin Cancer Center | Ashland | Wisconsin | قيد التجنيد |
| Duluth Clinic Ashland | Ashland | Wisconsin | قيد التجنيد |
| Grady Health System | Atlanta | Georgia | قيد التجنيد |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | قيد التجنيد |
| Piedmont Hospital | Atlanta | Georgia | قيد التجنيد |
| Emory University Hospital Midtown | Atlanta | Georgia | قيد التجنيد |
| Sutter Auburn Faith Hospital | Auburn | California | نشط، دون تجنيد |
| Sutter Cancer Centers Radiation Oncology Services-Auburn | Auburn | California | نشط، دون تجنيد |
| Rush-Copley Medical Center | Aurora | Illinois | قيد التجنيد |
| UCHealth University of Colorado Hospital | Aurora | Colorado | قيد التجنيد |
| Dell Seton Medical Center at The University of Texas | Austin | Texas | نشط، دون تجنيد |
| Mount Sinai Comprehensive Cancer Center at Aventura | Aventura | Florida | نشط، دون تجنيد |
| Saint Alphonsus Cancer Care Center-Baker City | Baker City | Oregon | قيد التجنيد |
| Mercy Oncology and Hematology - Clayton-Clarkson | Ballwin | Missouri | قيد التجنيد |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | نشط، دون تجنيد |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | قيد التجنيد |
| CommonSpirit Saint Joseph Hospital - Bardstown | Bardstown | Kentucky | قيد التجنيد |
| Advocate Good Shepherd Hospital | Barrington | Illinois | قيد التجنيد |
| Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | نشط، دون تجنيد |
| Bronson Battle Creek | Battle Creek | Michigan | قيد التجنيد |
| Essentia Health - Baxter Clinic | Baxter | Minnesota | قيد التجنيد |
| UPMC-Heritage Valley Health System Beaver | Beaver | Pennsylvania | نشط، دون تجنيد |
| Indu and Raj Soin Medical Center | Beavercreek | Ohio | نشط، دون تجنيد |
| Overlake Medical Center | Bellevue | Washington | مُعلَّق |
| Nebraska Medicine-Bellevue | Bellevue | Nebraska | نشط، دون تجنيد |
| PeaceHealth Saint Joseph Medical Center | Bellingham | Washington | قيد التجنيد |
يُدرَج 733 موقعاً إضافياً في سجل السجل.
مستندات الدراسة
لا تُرتبط أي مستندات في سجل السجل هذا.
التغيّرات عبر الزمن
- 5 أغسطس 2026
أُضيف موقع
3 sites added (783 total)
780783