BKM120 as Second-line Therapy for Advanced Endometrial Cancer

NCT01289041 | Completed Phase 2 Results

• 2 other identifiers: CBKM120C22012010-022015-19
• Study Type: interventional
• Target: 70
• Locations: 13 countries
• Sites: 42

Brief Summary

This is a prospective multi-center, open-label, single arm, Phase II study to investigate the safety and efficacy of BKM120 in patients with advanced endometrial carcinoma whose disease progressed on or after a first-line antineoplastic treatment. Patients will receive BKM120 orally at a dose of 100 mg/day. Availability of tumor specimen (either archival tissue or a fixed fresh biopsy) is mandatory for assessment of the PI3K (Phosphatidylinositol 3 Kinase (PI3K) pathway activation status.

Conditions

Advanced Endometrial Cancer

Keywords

Advanced endometrial cancer; PI3K pathway; second-line treatment

Outcome Measures

Primary Outcomes (1)

• Best Overall Response Rate (BORR) According to PI3K Activation Pathway Status

  BOR was determined based on investigator assessment of overall lesion response using RECIST criteria guidelines. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

  24 months

Secondary Outcomes (2)

• Progression Free Survival (PFS) According to PI3K Activation Pathway Status

  24 months

• Overall Survival (OS) According to PI3K Activation Pathway Status

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months

Study Arms (1)

All Patients

EXPERIMENTAL

Drug: BKM120

Interventions

BKM120 DRUG

Also known as: Buparlisib

All Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
• histologically confirmed diagnosis of advanced endometrial carcinoma with available tissue specimen for identification of PI3K pathway activation (archival tissue or a fixed fresh biopsy)
• one prior line of antineoplastic treatment with a cytotoxic agent
• objective progression of disease after prior treatment and at least one measurable lesion as per RECIST criteria
• adequate bone marrow and organ function

You may not qualify if:

• previous treatment with PI3K and/or mTOR inhibitors
• symptomatic CNS metastases
• concurrent malignancy or malignancy within 3 years of study enrollment
• Active mood disorder as judged by investigator or medically documented history of mood disorder (e.g. major depressive episode, bipolar disorder, obsessive-compulsive disorder, schizophrenia, etc.), ≥ CTCAE grade 3 anxiety
• pelvic and/or para-aortic radiotherapy ≤ 28 days prior to enrollment in the study
• poorly controlled diabetes mellitus (HbA1c \> 8 %)
• history of cardiac dysfunction or active cardiac disease as specified in the protocol
• impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (42)

St. Joseph's Hospital & Medical Center St Joseph's

Phoenix, Arizona, 85013, United States

Location

Highlands Oncology Group Dept of Highlands Oncology Grp

Fayetteville, Arkansas, 72703, United States

Location

Morristown Memorial Hospital MMH

Morristown, New Jersey, 07962, United States

Location

Carolinas HealthCare Systems Blumenthal Cancer Center

Charlotte, North Carolina, 28207, United States

Location

University of Oklahoma Health Sciences Center OU Health

Oklahoma City, Oklahoma, 73104, United States

Location

Sarah Cannon Research Institute SCRI (2)

Nashville, Tennessee, 37203, United States

Location

Texas Oncology, P.A. Austin

Bedford, Texas, 76022, United States

Location

South Texas Oncology and Hematology, PA South Tex Onc

San Antonio, Texas, 78258, United States

Location

Cancer Care Northwest CC Northwest- Spokane South(3)

Spokane, Washington, 99202, United States

Location

Novartis Investigative Site

Parkville, Victoria, 3050, Australia

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

Novartis Investigative Site

Liège, 4000, Belgium

Location

Novartis Investigative Site

Wilrijk, 2610, Belgium

Location

Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, 20220410, Brazil

Location

Novartis Investigative Site

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Novartis Investigative Site

Hamilton, Ontario, L8V 5C2, Canada

Location

Novartis Investigative Site

Toronto, Ontario, M5G 2M9, Canada

Location

Novartis Investigative Site

Montreal, Quebec, H2L 4M1, Canada

Location

Novartis Investigative Site

Le Mans, 72015, France

Location

Novartis Investigative Site

Lyon, 69373, France

Location

Novartis Investigative Site

Nice, 06189, France

Location

Novartis Investigative Site

Toulouse, 31059, France

Location

Novartis Investigative Site

Berlin, 10367, Germany

Location

Novartis Investigative Site

Berlin, 13353, Germany

Location

Novartis Investigative Site

Cologne, 50937, Germany

Location

Novartis Investigative Site

Mainz, 55131, Germany

Location

Novartis Investigative Site

Milan, MI, 20141, Italy

Location

Novartis Investigative Site

Aviano, PN, 33081, Italy

Location

Novartis Investigative Site

Roma, RM, 00168, Italy

Location

Novartis Investigative Site

Bologna, 40138, Italy

Location

Novartis Investigative Site

Napoli, 80131, Italy

Location

Novartis Investigative Site

Nagoya, Aichi-ken, 464-8681, Japan

Location

Novartis Investigative Site

Chuo-ku, Tokyo, 104-0045, Japan

Location

Novartis Investigative Site

Minato-ku, Tokyo, 105-8471, Japan

Location

Novartis Investigative Site

Warsaw, 00973, Poland

Location

Novartis Investigative Site

Saint Petersburg, 198255, Russia

Location

Novartis Investigative Site

Singapore, 229899, Singapore

Location

Novartis Investigative Site

Barcelona, Catalonia, 08036, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46009, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46026, Spain

Location

Novartis Investigative Site

Madrid, 28033, Spain

Location

Novartis Investigative Site

Madrid, 28046, Spain

Location

MeSH Terms

Interventions

NVP-BKM120

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2011
• First Posted: February 3, 2011
• Study Start: February 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 30, 2019
• Results First Posted: April 10, 2015

Record last verified: 2019-05

Locations

CA (4); IT (5); DE (4); JP (3); FR (4); RU (1); BR (1); BE (3); US (9); AU (1); PL (1); SG (1); ES (5)