BEZ235 Trial in Patients With Advanced Endometrial Carcinoma

NCT01290406 | Withdrawn Phase 2

• 3 other identifiers: CBEZ235C22012010-024396-12EudraCT 2010-024396-12
• Study Type: interventional
• Target: N/A
• Locations: 12 countries
• Sites: 59

Brief Summary

This is an open label and single arm study to investigate the safety and efficacy of BEZ235 in adult women with endometrial carcinoma whose disease progressed (or recurred) while on or after first-line antineoplastic treatment for advanced endometrial carcinoma.

Conditions

Endometrial Cancer

Keywords

Endometrial cancer,; uterine cancer,; PI3K,; mTOR,; targeted therapy

Outcome Measures

Primary Outcomes (1)

• assess the efficacy of BEZ235 as measured by Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST)

  every 8 weeks

Secondary Outcomes (2)

• evaluate additional efficacy parameters (e.g. Disease Control Rate, Progression-Free Survival)

  every 8 weeks

• evaluate safety of BEZ235. Safety assessments will include vital signs, laboratory tests, and frequency of adverse events (non-serious and serious).

  Treatment start until 30 days after the last dose

Study Arms (1)

BEZ235

EXPERIMENTAL

Drug: BEZ235

Interventions

BEZ235 DRUG

BEZ235

Eligibility Criteria

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

You may qualify if:

• Female ≥ 18 years
• Histological confirmed diagnosis of advanced endometrial carcinoma with available tissue specimen, either archival tissue or fresh formalin fixed tumor biopsy
• Objective and radiologically confirmed progression of disease after prior first-line treatment
• Recovery (to grade ≤ 1) from all clinically significant toxicities related to prior therapies (except alopecia) with adequate bone marrow and organ functions
• At least one measurable lesion as per RECIST
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

You may not qualify if:

• Previous treatment with PI3K and/or mammalian Target Of Rapamycin (mTOR) inhibitors
• More than one line of prior treatment for advanced or metastatic disease
• Active uncontrolled or symptomatic Central Nervous System (CNS) metastases
• Concurrent malignancy or malignancy in the last 3 years prior to start of study treatment
• Wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to enrollment in this study
• Active cardiac disease (e.g. Left Ventricular Ejection Fraction (LVEF) \< 50%, Q-T interval corrected for heart rate (QTcF) \> 480 msec on screening Electrocardiogram (ECG), unstable angina pectoris, ventricular, supraventricular or nodal arrhythmias)
• Inadequately controlled hypertension
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BEZ235
• Drugs with a known risk to induce Torsades de Pointes, moderate and strong inhibitors or inducers of CYP3A4, warfarin and coumadin analogues, Luteinizing Hormone-Releasing Hormone (LHRH) agonists
• Pregnant or nursing (lactating) woman

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (59)

St. Joseph's Hospital & Medical Center

Phoenix, Arizona, 85013, United States

Location

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

Location

City of Hope Medical center

Duarte, California, 91010, United States

Location

Holy Cross Hospital

Silver Spring, Maryland, 20910-1484, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Morriswon Memorial Hospital

Morristown, New Jersey, 07960, United States

Location

Carolinas Healthcare Systems

Charlotte, North Carolina, 28203, United States

Location

Cancer Centers of North Carolina

Raleigh, North Carolina, 27607, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73126-0901, United States

Location

GHS

Danville, Pennsylvania, United States

Location

Sarah Gautam Rau

Nashville, Tennessee, 37203-1197, United States

Location

Texas Oncology, P.A.

Austin, Texas, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

STOH

San Antonio, Texas, United States

Location

Pacific Gynecology Specialists

Seattle, Washington, 98104, United States

Location

Cancer Care Northwest

Spokane, Washington, 99202, United States

Location

Novartis Investigative Site

Rio de Janeiro, Brazil

Location

Novartis Investigative Site

São Paulo, Brazil

Location

Novartis Investigative Site

Hamilton, Canada

Location

Novartis Investigative Site

Montreal, Canada

Location

Novartis Investigative Site

Toronto, Canada

Location

Novartis Investigative Site

Vancouver, Canada

Location

Novartis Investigative Site

Bordeaux, France

Location

Novartis Investigative Site

Caen, France

Location

Novartis Investigative Site

La Roche-sur-Yon, France

Location

Novartis Investigative Site

Le Mans, France

Location

Novartis Investigative Site

Lyon, France

Location

Novartis Investigative Site

Marseille, France

Location

Novartis Investigative Site

Nice, France

Location

Novartis Investigative Site

Paris, France

Location

Novartis Investigative Site

Saint-Brieuc, France

Location

Novartis Investigative Site

Toulouse, France

Location

Novartis Investigative Site

Berlin, Germany

Location

Novartis Investigative Site

Cologne, Germany

Location

Novartis Investigative Site

Freiburg im Breisgau, Germany

Location

Novartis Investigative Site

Jena, Germany

Location

Novartis Investigative Site

Lübeck, Germany

Location

Novartis Investigative Site

Mainz, Germany

Location

Novartis Investigative Site

München, Germany

Location

Novartis Investigative Site

Aviano, Italy

Location

Novartis Investigative Site

Barcelona, Italy

Location

Novartis Investigative Site

Bologna, Italy

Location

Novartis Investigative Site

Brescia, Italy

Location

Novartis Investigative Site

Capmobso, Italy

Location

Novartis Investigative Site

Milan, Italy

Location

Novartis Investigative Site

Modena, Italy

Location

Novartis Investigative Site

Napoli, Italy

Location

Novartis Investigative Site

Roma, Italy

Location

Novartis Investigative Site

Aichi, Japan

Location

Novartis Investigative Site

Hyōgo, Japan

Location

Novartis Investigative Site

Tokyo, Japan

Location

Novartis Investigative Site

Środa Wielkopolska, Poland

Location

Novartis Investigative Site

Warzawa, Poland

Location

Novartis Investigative Site

Saint Petersburg, Russia

Location

Novartis Investigative Site

Singapore, Singapore

Location

Novartis Investigative Site

Madrid, Spain

Location

Novartis Investigative Site

Oviedo, Spain

Location

Novartis Investigative Site

Valencia, Spain

Location

Novartis Investigative Site

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Endometrial Neoplasms; Uterine Neoplasms

Interventions

dactolisib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: February 7, 2011
• Study Start: March 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2017
• Last Updated: June 21, 2012

Record last verified: 2012-06

Locations

FR (10); RU (1); TU (1); CA (4); BR (2); US (16); SG (1); PL (2); IT (9); ES (3); DE (7); JP (3)