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Safety and Efficacy of CC-486 in Previously Treated Patients With Locally Advanced or Metastatic Nasopharyngeal Carcinoma

NCT ID: NCT02269943

Last Updated: 2018-12-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-13

Study Completion Date

2017-04-20

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of CC-486 in previously treated patients with locally advanced or metastatic nasopharyngeal carcinoma having failed one to two previous regimens, including platinum-based chemotherapy. Participants will be enrolled according to a Simon two-stage design; if the predefined activity is met (\>4 responses \[complete response; partial response {CR/PR}\] out of the first 17 evaluable participants based on independent radiological assessment), then the study will continue to enroll an additional 34 participants. If 4 or less responses out of 17 are observed, then the study enrollment will be stopped.

Detailed Description

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Conditions

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Nasopharyngeal Neoplasms

Keywords

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Metastatic nasopharyngeal carcinoma oral azacitidine oral AZA CC-486 metastatic recurrent nasopharyngeal carcinoma nasal solid tumors locally advanced rare head and neck cancer nasopharynx single chemotherapy agent Epstein-Barr Virus (EBV) + nasopharyngeal carcinoma EBV-DN Celgene Sponsor-study oral chemotherapy phase 2 oral Vidaza EBV promoter methylation hypomethylation tumor infiltrating lymphocytes (TILs) EBV gene expression neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CC-486

CC-486 will be administered orally every day on Days 1-14 of a 21 day cycle at a dose of 300 mg. The first 6 participants of Asian-Pacific ethnicity will receive a starting dose of 200 mg. If there are no safety concerns, the 300 mg dose will be administered to all subsequent participants of Asian-Pacific ethnicity.

Group Type EXPERIMENTAL

CC-486

Intervention Type DRUG

Interventions

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CC-486

Intervention Type DRUG

Other Intervention Names

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oral azacitidine

Eligibility Criteria

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Inclusion Criteria

* Age = or \> 18 years Histological or cytological diagnosis of undifferentiated or poorly differentiated nasopharyngeal carcinoma that is locally advanced or metastatic.
* Disease progression either clinically or radiographically after 1-2 previous regimens.
* Patient has received a platinum containing regimen. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Radiographically-documented measureable disease.
* Adequate organ and bone marrow functions.
* Willingness to follow pregnancy precautions.

Exclusion Criteria

* History of, or current brain metastasis. Any other malignancy within 5 years prior to randomization with the exception of adequately treated in situ carcinoma of the cervix, uteri, or non-melanomatous skin cancer (all treatment of which should have been completed 6 months prior to enrollment), in situ squamous cell carcinoma of the breast, or incidental prostate cancer.
* Previous treatment with azacitidine (any formulation), decitabine, any other hypomethylating agent.
* History of gastrointestinal disorder or defect. Impaired ability to swallow oral medication. Persistent diarrhea or malabsorption.
* Active cardiac disease and human immunodeficiency virus (HIV) infection
* Active bleeding; pathological condition that carries a high risk of bleeding; risk of pseudoaneurysm of the internal carotid artery and carotid blowout syndrome.
* Major surgery within 14 days prior to starting Investigational Product or has not recovered from major side effects.
* Another investigational therapy within 28 days or 5 half lives of randomization/enrollment, whichever is shorter.
* Patient has not recovered from the acute toxic effects of prior anticancer therapy, radiation, or major surgery/significant trauma.
* Radiotherapy \< or = 4 weeks or limited field radiation for palliation \< or = 2 weeks prior to starting with the investigational product.
* Pregnancy/Breast feeding
* Any condition that places the patient at unacceptable risk if he/she were to participate in the study or that confounds the ability to interpret data from the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Abderahim (Rahim) Fandi, MD, PhD

Role: STUDY_DIRECTOR

Celgene

Locations

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Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Columbia Comprehensive Cancer Care Clinic

Jefferson City, Missouri, United States

Site Status

Levine Cancer Institute

Charlotte, North Carolina, United States

Site Status

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status

McGill University

Montreal, Quebec, Canada

Site Status

Institut Hospitalier Franco-Britannique

Levallois-Perret, , France

Site Status

Institut Curie

Paris, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

University General Hospital of Heraklion

Heraklion, , Greece

Site Status

Thermi Clinic

Thessaloniki, , Greece

Site Status

Istituto Nazionale Dei Tumori

Milan, , Italy

Site Status

National Cancer Center

Singapore, , Singapore

Site Status

Singapore Oncology Consultants

Singapore, , Singapore

Site Status

Johns Hopkins Singapore International Medical Centre

Singapore, , Singapore

Site Status

Instituto Catalan de Oncologia-Hospital Duran

Barcelona, , Spain

Site Status

Hospital Universitario Madrid Sanchinarro

Madrid, , Spain

Site Status

Hospital Universitario de Salamanca

Salamanca, , Spain

Site Status

Chang Gung Medical Foundation, Kaohsiung Memorial Hospital

Niao-Sung Hsiang Kaohsiung County, , Taiwan

Site Status

China Medical University Hospital

Taichung, , Taiwan

Site Status

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

Hopital Abderrahman Mami de Pneumo-Phtisiologie de l'Ariana

Aryanah, , Tunisia

Site Status

Institut Salah Azaiez

Bab Saadoun, , Tunisia

Site Status

Hospital Habib Bourguiba

Sfax, , Tunisia

Site Status

Countries

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Hong Kong Romania United States Canada France Greece Italy Singapore Spain Taiwan Tunisia

References

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Von Hoff DD, Rasco DW, Heath EI, Munster PN, Schellens JHM, Isambert N, Le Tourneau C, O'Neil B, Mathijssen RHJ, Lopez-Martin JA, Edenfield WJ, Martin M, LoRusso PM, Bray GL, DiMartino J, Nguyen A, Liu K, Laille E, Bendell JC. Phase I Study of CC-486 Alone and in Combination with Carboplatin or nab-Paclitaxel in Patients with Relapsed or Refractory Solid Tumors. Clin Cancer Res. 2018 Sep 1;24(17):4072-4080. doi: 10.1158/1078-0432.CCR-17-3716. Epub 2018 May 15.

Reference Type DERIVED
PMID: 29764853 (View on PubMed)

Provided Documents

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Document Type: Study Protocol: CC-486-NPC-001_original protocol_Redacted.11July2014

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Document Type: Study Protocol: CC-486-NPC-001.01.protocolAM1_RedactedOctober2014

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Document Type: Study Protocol: CC-486-NPC-001_protocolAM2_Redacted.03April2015

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Document Type: Study Protocol: CC-486-NPC-001_protocolAM3_Redacted.23September2016

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2014-001745-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CC-486-NPC-001

Identifier Type: -

Identifier Source: org_study_id