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PI3K Pathway Activated TumorsPhase 2SIGNATURENCT01833169

BKM120 for Patients With PI3K-activated Tumors

A Phase 2 study testing BKM120 in people with PI3K Pathway Activated Tumors, run by Novartis Pharmaceuticals at 59 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this signal seeking study was is to determine whether treatment with BKM120 demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
PI3K Pathway Activated Tumors
What is being tested?
BKM120
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
59 sitesUnited States
Study dates
29 Mar 2013to 26 Sep 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient had a confirmed diagnosis of a solid tumor or hematological malignancy with the exception of endometrial cancer, glioblastoma, nonsmall cell lung cancer, prostate cancer or breast cancer.
  • Patient's tumor was evaluated and pre-identified to have activation of the PI3K pathway, at a CLIA certified laboratory
  • Patient must have received at least one prior treatment for recurrent metastatic and /or locally advanced disease and for whom no standard therapy options was anticipated to result in a durable remission.
  • Patient must have had progressive and measurable disease as per RECIST 1.1. or other appropriate hematological guidelines
  • Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Who cannot join

  • Patient had received previous treatment with BKM120 Patient had symptomatic CNS metastases Patient had mood disorder as outlined in Section 5 Patient had received chemotherapy or other anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to starting study drug.

Trial locations and contacts

59 sites in 1 country.

59 sites in 1 country

United States59 sites

  • New York Oncology Hematology NY Onc Hem

    Albany, New York, 12208

  • Cancer Center at Presbyterian

    Albuquerque, New Mexico

  • Michigan Medicine University of Michigan Int. Medicine Oncology

    Ann Arbor, Michigan, 48109 5271

  • University Cancer & Blood Center, LLC

    Athens, Georgia, 30607

  • Eastern Maine Medical Center Research Center SC

    Bangor, Maine, 04401

  • Bend Memorial Clinic Bend Mem. Clinic

    Bend, Oregon, 97701

  • Mount Auburn Hospital

    Cambridge, Massachusetts, 02138

  • Waverly Hematology Oncology

    Cary, North Carolina, 27518

  • University of N C at Chapel Hill Physician Office Building

    Chapel Hill, North Carolina, 27599-7600

  • Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology

    Chattanooga, Tennessee, 37404

  • Lurie Children's Hospital of Chicago Developmental Therapeutics

    Chicago, Illinois, 60611

  • Cleveland Clinic Foundation Cleveland Clinic (19)

    Cleveland, Ohio, 44195

  • Mid Ohio Oncology/Hematology Mark H. Zangmeister Center

    Columbus, Ohio, 43219

  • Texas Oncology P A Round Rock

    Dallas, Texas, 75251

  • Texas Oncology Sammons Cancer Center Sammons Cancer Center (10)

    Dallas, Texas, 78246

  • Cancer Care Specialists of Central Illinois

    Decatur, Illinois, 62526

  • Duke University Medical Center Seeley G. Mudd Bldg.

    Durham, North Carolina, 27710

  • Virginia Cancer Specialists Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • Florida Cancer Specialists Dept of Oncology (2)

    Fort Myers, Florida, 33901

  • Texas Oncology, P.A. Texas Oncololgy, P.A. (8)

    Fort Worth, Texas, 76104

  • Gettysburg Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Cancer and Hematology Centers of West Michigan Dept. of Oncology

    Grand Rapids, Michigan, 49546

  • Rocky Mountain Cancer Centers RMCC - Aurora

    Greenwood Village, Colorado

  • Oncology Consultants Oncology Group

    Houston, Texas, 77024

  • MD Anderson Cancer Center/University of Texas MD Anderson Cancer Center (3)

    Houston, Texas, 77030

  • University of Iowa Hospitals & Clinics Regulatory Contact 2

    Iowa City, Iowa, 52242

  • Kadlec Clinic Hematology and Oncology Kadlec Clinic Hematology & Onc

    Kennewick, Washington, 99336

  • Comprehensive Cancer Centers

    Las Vegas, Nevada, 89169

  • West Cancer Clinic

    Memphis, Tennessee, 38120

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Minnesota Oncology Hematology, P.A. Minnesota Oncology Hematology

    Minneapolis, Minnesota, 55404

  • Hematology Oncology Associates of Northern New Jersey PA Regional Cancer Care Assoc.

    Morristown, New Jersey, 07962

  • Intermountain Medical Center Intermountain Healthcare

    Murray, Utah, 84157

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • West Penn Allegheny Oncology Network

    Natrona Heights, Pennsylvania, 15065

  • Southeastern Regional Medical Center

    Newnan, Georgia, 30265

  • Whittingham Cancer Center Norwalk Hospital

    Norwalk, Connecticut, 06856

  • Eastern Connecticut Hematology & Oncology Associates The Norwich Cancer Center

    Norwich, Connecticut, 06360

  • Nebraska Cancer Specialists Oncology Hematology West

    Omaha, Nebraska, 68154

  • Florida Hospital Cancer Institute FL Hosp. Cancer Instit.

    Orlando, Florida, 32804

  • Illinois Cancer Care P.C. IL. Cancer Care

    Peoria, Illinois, 61615-7828

  • Illinois Cancer Care P.C.

    Peoria, Illinois, 61615-7828

  • Arizona Oncology Associates HOPE Division

    Phoenix, Arizona

  • University of Pittsburgh Medical Center UPMC

    Pittsburgh, Pennsylvania, 15213

  • Northwest Cancer Specialists Compass Oncology (36)

    Portland, Oregon, 97210

  • Oregon Health and Science University Oregon Health & Science U (56)

    Portland, Oregon, 97239

  • Blue Ridge Research Center at Roanoke Neurological Center McKesson Specialty Care

    Roanoke, Virginia, 24018

  • Salem Health

    Salem, Oregon, 97309

  • Cancer Care Centers of South Texas HOAST CCC of So. TX-San Antonio (3)

    San Antonio, Texas, 78229

  • Sarcoma Oncology Center

    Santa Monica, California, 90403

  • Cancer Treatment Centers of America Southwestern Regional Med. Ctr

    Schaumburg, Illinois, 60173

  • Arizona Oncology Associates PC- HAL

    Sedona, Arizona, 86336

  • Sanford University of South Dakota Medical Center Sanford Health

    Sioux Falls, South Dakota, 57104

  • Northern Indiana Cancer Research Consortium No. Indiana Cancer Res.

    South Bend, Indiana, 46617

  • Northwest Medical Specialties Hematology/Oncology

    Tacoma, Washington, 98405

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Florida Cancer Specialists

    West Palm Beach, Florida, 33401

  • Abington Hematology Oncology Associates, Inc Abington Hem Onc Assoc (5)

    Willow Grove, Pennsylvania, 19090

Other trials in United States

About this study

Official title: Modular Phase II Study to Link Targeted Therapy to Patients With Pathway Activated Tumors: Module 1 - BKM120 for Patients With PI3K-activated Tumors

The purpose of this signal seeking study was is to determine whether treatment with BKM120 demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.

Being tested
BKM120
Keywords
Solid tumor, malignancy, hematologic malignancy, PI3K pathway activation, P13K activated tumors, BKM120, signature, AML, acute myelogenous leukemia, cervical, ovarian, hepatobiliary, buparlisib
Medical subject headings
Neoplasms, Hematologic Neoplasms, Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BKM120Drug

    BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28-day cycle

Study groups in NCT01833169
Study groupRoleWhat they receive
BKM120ExperimentalBKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle
Receives: Drug: BKM120

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participant Clinical Benefit Response Rate

    Clinical benefit rate for patients with solid tumors will be assessed using RECIST 1.1 and will include responses of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) at >=16 weeks. For hematologic tumors other appropriate hematological response criteria was applied. Response criteria: CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm., PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study, PD= At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline

    Measured: Week 16

Secondary outcomes (7)

  1. Overall Response of Partial Response (PR) or Greater. PR=at Least a 30% Decrease in the Sum of Diameters of Target Lesions, Taking as Reference the Baseline Sum Diameters

    Overall Response (OR) of Partial Response (PR) or greater is based on local investigator assessment. For patients with solid tumors, the assessment criteria will be RECIST 1.1 and will include responses of CR and/or PR. For hematologic tumors other appropriate hematological response criteria apply

    Measured: baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months

  2. Progression-Free Survival - Number of Participants With an Event

    Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause

    Measured: Every 8 Weeks until death, assessed up to 24 months

  3. Progression-Free Survival (PFS)- Kaplan-Meier Estimates of PFS Timing in Months

    Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause

    Measured: baseline up to 24 months

  4. Progression-Free Survival (PFS)- Kaplan-Meier Estimates of PFS Rate in Percentages

    Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause.

    Measured: baseline up to 24 months

  5. Overall Survival - Number of Participants With an Event

    Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact

    Measured: Every 8 Weeks until death, assessed up to 24 months

  6. Overall Survival (OS)- Kaplan-Meier Estimates of OS Timing in Months

    Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact

    Measured: baseline up to 24 months

  7. Overall Survival (OS)- Kaplan-Meier Estimates of OS Rate in Percentages

    Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact

    Measured: baseline up to 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2013 (estimated)
  2. Study start29 Mar 2013
  3. Primary completion26 Sep 2016
  4. Study completion26 Sep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01833169
Sponsor's protocol ID
CBKM120ZUS40
Acronym
SIGNATURE
Status last verified
Oct 2018
First submitted
5 Apr 2013
Last updated
19 Oct 2018
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BKM120 in people with PI3K Pathway Activated Tumors, run by Novartis Pharmaceuticals at 59 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participant Clinical Benefit Response Rate (time frame: Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01833169.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2018.

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