BKM120 as Second-line Therapy for Advanced Endometrial Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01289041
First received: January 26, 2011
Last updated: April 15, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Endometrial Cancer |
Drug: BKM120 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II, Single-arm Study of Orally Administered BKM120 as Second-line Therapy in Patients With Advanced Endometrial Carcinoma |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Determine the efficacy of BKM120 (parameter: Overall Response Rate) in all patients and patients with an activated PI3K pathway status [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Determine the efficacy of BKM120 (parameter: Overall Response Rate) in patients with a non-activated PI3K pathway status [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Evaluate additional efficacy parameters (Time to Response, Duration of Response, Progression Free Survival, Overall Survival) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Evaluate safety of BKM120 (frequency and severity of adverse events, number of lab values worsening form baseline based on the Common Terminology Criteria of Adverse Events (CTCAE) grade) [ Time Frame: up to 30 days after treatment discontinuation ] [ Designated as safety issue: No ]
| Enrollment: | 113 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | May 2013 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: BKM120 | Drug: BKM120 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289041
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Hide Study LocationsLocations
| United States, Arizona | |
| St. Joseph's Hospital & Medical Center St Jospeh's | |
| Phoenix, Arizona, United States, 85013 | |
| United States, Arkansas | |
| Highlands Oncology Group Dept of Highlands Oncology Grp | |
| Fayetteville, Arkansas, United States, 72703 | |
| United States, New Jersey | |
| Morristown Memorial Hospital MMH | |
| Morristown, New Jersey, United States, 07962 | |
| United States, North Carolina | |
| Carolinas HealthCare Systems Blumenthal Cancer Center | |
| Charlotte, North Carolina, United States, 28207 | |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center OU Health | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Tennessee | |
| Sarah Cannon Research Institute SCRI (2) | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Texas Oncology, P.A. Austin | |
| Bedford, Texas, United States, 76022 | |
| South Texas Oncology and Hematology, PA South Tex Onc | |
| San Antonio, Texas, United States, 78258 | |
| United States, Washington | |
| Cancer Care Northwest CC Northwest- Spokane South(3) | |
| Spokane, Washington, United States, 99202 | |
| Australia, New South Wales | |
| Novartis Investigative Site | |
| Randwick, New South Wales, Australia, 2031 | |
| Australia, Victoria | |
| Novartis Investigative Site | |
| Melbourne, Victoria, Australia, 3002 | |
| Belgium | |
| Novartis Investigative Site | |
| Leuven, Belgium, 3000 | |
| Novartis Investigative Site | |
| Liege, Belgium, 4000 | |
| Novartis Investigative Site | |
| Wilrijk, Belgium, 2610 | |
| Brazil | |
| Novartis Investigative Site | |
| Rio de Janeiro, RJ, Brazil, 20220410 | |
| Canada, British Columbia | |
| Novartis Investigative Site | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Canada, Ontario | |
| Novartis Investigative Site | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Novartis Investigative Site | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Canada, Quebec | |
| Novartis Investigative Site | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| France | |
| Novartis Investigative Site | |
| Le Mans Cedex, France, 72015 | |
| Novartis Investigative Site | |
| Lyon Cedex, France, 69373 | |
| Novartis Investigative Site | |
| Nice Cedex 2, France, 06189 | |
| Novartis Investigative Site | |
| Toulouse Cedex 3, France, 31052 | |
| Germany | |
| Novartis Investigative Site | |
| Berlin, Germany, 10367 | |
| Novartis Investigative Site | |
| Berlin, Germany, 13353 | |
| Novartis Investigative Site | |
| Köln, Germany, 50924 | |
| Novartis Investigative Site | |
| Mainz, Germany, D-55101 | |
| Italy | |
| Novartis Investigative Site | |
| Milano, MI, Italy, 20141 | |
| Novartis Investigative Site | |
| Aviano, PN, Italy, 33081 | |
| Novartis Investigative Site | |
| Roma, RM, Italy, 00168 | |
| Novartis Investigative Site | |
| Bologna, Italy, 40138 | |
| Novartis Investigative Site | |
| Napoli, Italy, 80131 | |
| Japan | |
| Novartis Investigative Site | |
| Nagoya, Aichi, Japan, 464-8681 | |
| Novartis Investigative Site | |
| Chuo-ku, Tokyo, Japan, 104-0045 | |
| Novartis Investigative Site | |
| Minato-ku, Tokyo, Japan, 105-8471 | |
| Poland | |
| Novartis Investigative Site | |
| Warszawa, Poland, 00973 | |
| Russian Federation | |
| Novartis Investigative Site | |
| St. Petersburg, Russian Federation, 198255 | |
| Singapore | |
| Novartis Investigative Site | |
| Singapore, Singapore, 229899 | |
| Spain | |
| Novartis Investigative Site | |
| Oviedo, Asturias, Spain, 33006 | |
| Novartis Investigative Site | |
| Barcelona, Catalunya, Spain, 08036 | |
| Novartis Investigative Site | |
| Valencia, Comunidad Valenciana, Spain, 46009 | |
| Novartis Investigative Site | |
| Madrid, Spain, 28033 | |
| Novartis Investigative Site | |
| Madrid, Spain, 28046 | |
| Novartis Investigative Site | |
| Valencia, Spain, 46026 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01289041 History of Changes |
| Other Study ID Numbers: | CBKM120C2201, 2010-022015-19 |
| Study First Received: | January 26, 2011 |
| Last Updated: | April 15, 2013 |
| Health Authority: | United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration Belgium: Federal Agency for Medicinal Products and Health Products Brazil: National Health Surveillance Agency Canada: Health Canada China: Food and Drug Administration France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Italy: National Institute of Health Japan: Pharmaceuticals and Medical Devices Agency Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Russia: Ministry of Health of the Russian Federation Singapore: Health Sciences Authority Spain: Spanish Agency of Medicines Turkey: Ministry of Health |
Keywords provided by Novartis:
|
Advanced endometrial cancer PI3K pathway second-line treatment |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Sarcoma, Endometrial Stromal Adenoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms |
Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed Neoplasms by Histologic Type Sarcoma Neoplasms, Connective and Soft Tissue Endometrial Stromal Tumors Neoplasms, Glandular and Epithelial |
ClinicalTrials.gov processed this record on May 23, 2013