A Phase 2, worldwide study conducted to see if patients with cancer in the area behind the nose and above the back of the throat can benefit from treatment with a single drug called CC-486 (Oral Azacitidine). This study will also test the safety of the drug while patients are taking it.

• Register: EUCTR
• Last refreshed on: 5 June 2017
• Main ID: EUCTR2014-001745-25-GR
• Date of registration: 29/04/2015
• Prospective Registration: No
• Primary sponsor: Celgene Corporation
• Public title: A Phase 2, worldwide study conducted to see if patients with cancer in the area behind the nose and above the back of the throat can benefit from treatment with a single drug called CC-486 (Oral Azacitidine). This study will also test the safety of the drug while patients are taking it.
• Scientific title: A Phase 2, Multicenter, International, Single Arm Study to Assess the Safety and Efficacy of Single Agent CC-486 (Oral Azacitidine) in Previously Treated Subjects With Locally Advanced or Metastatic Nasopharyngeal Carcinoma
• Date of first enrolment: 29/01/2015
• Target sample size: 55
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-001745-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: ClinicalTrialDisclosure
• Affiliation: Celgene Corporation

• Name: ClinicalTrialDisclosure
• Affiliation: Celgene Corporation

Key inclusion & exclusion criteria

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 to 2 previous regimens.
- Patient has received a platinum containing regimen.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
- Radiographically-documented measurable disease.
- Adequate organ and bone marrow functions.
- Willingness to follow pregnancy precautions.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 47
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

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 nonmelanomatous 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, or any other hypomethylating agent.
- Impaired ability to swallow oral medication.
- Persistent diarrhea or malabsorption.
- 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.
- 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Locally advanced or metastatic nasopharyngeal carcinoma
MedDRA version: 18.0 Level: LLT Classification code 10028793 Term: Nasopharyngeal carcinoma System Organ Class: 100000004864

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: Oral Azacitidine
Product Code: CC-486
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: AZACITIDINE
CAS Number: 320-67-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Product Name: Oral Azacitidine
Product Code: CC-486
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: AZACITIDINE
CAS Number: 320-67-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Product Name: Oral Azacitidine
Product Code: CC-486
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: AZACITIDINE
CAS Number: 320-67-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Primary Outcome(s)

Secondary Objective: - To evaluate safety in all patients
- To evaluate pharmacokinetics of CC-486 in a subset of patients of Asian-Pacific Island ethnicity

Timepoint(s) of evaluation of this end point: - ORR and PFS: at screening within 28 days before the start of the Investigational Product and after that every 6 weeks (± 5 days) from Cycle 1 Day 1, for the first three tumor evaluations and then every 9 weeks until disease progression or start of a new anticancer treatment, or withdrawal of consent

Main Objective: To evaluate the efficacy of CC-486 in patients with nasopharyngeal carcinoma (NPC)

Primary end point(s): - Overall response rate (ORR)
- Progression-free survival (PFS)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: - OS: continuously during the trial and every 8 weeks (+/- 5 days) in the Follow-up Period
- Safety: continuously starting after informed consent signature, until 28 days after treatment discontinuation
- PK in a subset of patients of Asian-Pacific Island ethnicity: On each PK day prior to each dose administration and afterwards at 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, and 8h post-dose

Secondary end point(s): - Overall survival (OS)
- Safety
- Pharmacokinetics (PK) in a subset of patients of Asian-Pacific Island ethnicity

Secondary ID(s)

NCT02269943

2014-001745-25-ES

CC-486-NPC-001

Source(s) of Monetary Support

Celgene Corporation