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
בקצרה
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…
שלב 2דרושים 124 משתתפים783 אתריםמדינה אחת
קטגוריות
רשום במרשם אחד
- ClinicalTrials.govNCT02523014פתיחת רשומה זו ב־ClinicalTrials.govסונכרן לפני 3 שבועות
מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.
מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.
מתעניינים במחקר הזה?
התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.
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.
תקציר
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.
מצבים רפואיים
- Intracranial Meningioma
- Recurrent Meningioma
- NF2 Gene Mutation
זכאות
| מין | הכול |
|---|---|
| גילאים | 18 Years – ללא מקסימום |
| מתנדבים בריאים | לא |
זכאות כפי שנכתבה במרשם
זכאות במשפטים פשוטים
הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.
תכנון המחקר
| סוג המחקר | התערבותי |
|---|---|
| שלב | שלב 2 |
| הקצאה | לא אקראי |
| מודל ההתערבות | PARALLEL |
| מטרה ראשית | TREATMENT |
| הסתרה | NONE (0) |
| גיוס | דרושים 124 משתתפים |
נותן חסות ושותפים
- Alliance for Clinical Trials in Oncology נותן חסות
- National Cancer Institute (NCI) שותפים
- GlaxoSmithKline שותפים
- Genentech, Inc. שותפים
- Brain Science Foundation שותפים
זרועות והתערבויות
- 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.
התערבויות
- תרופה Abemaciclib
Given PO
- תרופה Capivasertib
Given PO
- תרופה FAK Inhibitor GSK2256098
Given PO
- תרופה Vismodegib
Given PO
מדדי תוצאה
מדד תוצאה ראשוני
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.
מסגרת זמן At 6 months
מדד תוצאה ראשוני
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.
מסגרת זמן Up to 2 years
מדד תוצאה משני
Overall survival (OS)
OS will be summarized for each cohort within each treatment group with Kaplan-Meier curves and estimates.
מסגרת זמן Up to 2 years
מדד תוצאה משני
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+.
מסגרת זמן Up to 4 weeks after completion of study treatment
תאריכים
| תאריך התחלה | 28 בספטמבר 2015 (בפועל) |
|---|---|
| סיום ראשוני | 1 בינואר 2027 (משוער) |
| סיום | 1 בינואר 2028 (משוער) |
| פורסם לראשונה | 14 באוגוסט 2015 (משוער) |
| עודכן לאחרונה | 2 בספטמבר 2026 |
| התוצאות פורסמו | לא צוין ברשומת המרשם |
| המצב אומת לאחרונה | ספטמבר 2026 |
בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.
מיקומים
448 אתרים מגייסים
United States
| מתקן | עיר | מדינה או אזור | מצב |
|---|---|---|---|
| Providence Regional Cancer System-Aberdeen | Aberdeen | Washington | מגייס |
| Riverwood Healthcare Center | Aitkin | Minnesota | מגייס |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | מגייס |
| Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania | מגייס |
| MyMichigan Medical Center Gratiot | Alma | Michigan | מגייס |
| MyMichigan Medical Center Alpena | Alpena | Michigan | מגייס |
| OSF Saint Anthony's Health Center | Alton | Illinois | מגייס |
| McFarland Clinic - Ames | Ames | Iowa | פעיל, ללא גיוס |
| Mary Greeley Medical Center | Ames | Iowa | פעיל, ללא גיוס |
| Cancer Care Center at Island Hospital | Anacortes | Washington | מושהה |
| Anchorage Oncology Centre | Anchorage | Alaska | מושהה |
| Anchorage Associates in Radiation Medicine | Anchorage | Alaska | מגייס |
| Alaska Women's Cancer Care | Anchorage | Alaska | מגייס |
| Alaska Oncology and Hematology LLC | Anchorage | Alaska | מגייס |
| Alaska Breast Care and Surgery LLC | Anchorage | Alaska | מגייס |
| Anchorage Radiation Therapy Center | Anchorage | Alaska | מושהה |
| Katmai Oncology Group | Anchorage | Alaska | מגייס |
| Providence Alaska Medical Center | Anchorage | Alaska | מגייס |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic | Ankeny | Iowa | מגייס |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor | Ann Arbor | Michigan | מגייס |
| Kaiser Permanente-Deer Valley Medical Center | Antioch | California | פעיל, ללא גיוס |
| Mission Hope Medical Oncology - Arroyo Grande | Arroyo Grande | California | מגייס |
| PCR Oncology | Arroyo Grande | California | מגייס |
| AdventHealth Infusion Center Asheville | Asheville | North Carolina | פעיל, ללא גיוס |
| Northwest Wisconsin Cancer Center | Ashland | Wisconsin | מגייס |
| Duluth Clinic Ashland | Ashland | Wisconsin | מגייס |
| Grady Health System | Atlanta | Georgia | מגייס |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | מגייס |
| Piedmont Hospital | Atlanta | Georgia | מגייס |
| Emory University Hospital Midtown | Atlanta | Georgia | מגייס |
| Sutter Auburn Faith Hospital | Auburn | California | פעיל, ללא גיוס |
| Sutter Cancer Centers Radiation Oncology Services-Auburn | Auburn | California | פעיל, ללא גיוס |
| Rush-Copley Medical Center | Aurora | Illinois | מגייס |
| UCHealth University of Colorado Hospital | Aurora | Colorado | מגייס |
| Dell Seton Medical Center at The University of Texas | Austin | Texas | פעיל, ללא גיוס |
| Mount Sinai Comprehensive Cancer Center at Aventura | Aventura | Florida | פעיל, ללא גיוס |
| Saint Alphonsus Cancer Care Center-Baker City | Baker City | Oregon | מגייס |
| Mercy Oncology and Hematology - Clayton-Clarkson | Ballwin | Missouri | מגייס |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | פעיל, ללא גיוס |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | מגייס |
| CommonSpirit Saint Joseph Hospital - Bardstown | Bardstown | Kentucky | מגייס |
| Advocate Good Shepherd Hospital | Barrington | Illinois | מגייס |
| Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | פעיל, ללא גיוס |
| Bronson Battle Creek | Battle Creek | Michigan | מגייס |
| Essentia Health - Baxter Clinic | Baxter | Minnesota | מגייס |
| UPMC-Heritage Valley Health System Beaver | Beaver | Pennsylvania | פעיל, ללא גיוס |
| Indu and Raj Soin Medical Center | Beavercreek | Ohio | פעיל, ללא גיוס |
| Overlake Medical Center | Bellevue | Washington | מושהה |
| Nebraska Medicine-Bellevue | Bellevue | Nebraska | פעיל, ללא גיוס |
| PeaceHealth Saint Joseph Medical Center | Bellingham | Washington | מגייס |
733 אתרים נוספים מצוינים ברשומת המרשם.
מסמכי המחקר
לא צורפו מסמכים ברשומת מרשם זו.
שינויים לאורך זמן
- 5 באוגוסט 2026
אתר נוסף
3 sites added (783 total)
780783