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.
- Conditions
- ocally advanced or metastatic nasopharyngeal carcinomaMedDRA version: 17.1Level: LLTClassification code 10028793Term: Nasopharyngeal carcinomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-001745-25-ES
- Lead Sponsor
- Celgene Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 55
- 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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of CC-486 in patients with nasopharyngeal carcinoma (NPC);Secondary Objective: - To evaluate safety in all patients<br>- To evaluate pharmacokinetics of CC-486 in a subset of patients of Asian-Pacific Island ethnicity;Primary end point(s): - Overall response rate (ORR) <br>- Progression-free survival (PFS);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
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Overall survival (OS)<br>- Safety<br>- Pharmacokinetics (PK) in a subset of patients of Asian-Pacific Island ethnicity;Timepoint(s) of evaluation of this end point: - OS: continuously during the trial and every 8 weeks (+/- 5 days) in the Follow-up Period<br>- Safety: continuously starting after informed consent signature, until 28 days after treatment discontinuation<br>- 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