Phase 2
N=36
Safety and Efficacy of CC-486 in Previously Treated Patients With Locally Advanced or Metastatic Nasopharyngeal Carcinoma
Nasopharyngeal Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT02269943 ↗Enrolled (actual)
36
Serious AEs
44.4%
Results posted
Jun 2018
Primary outcome: Primary: Percentage of Participants Who Achieved a Complete or Partial Response According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) Based on an Independent Radiology Assessment (IRA) — 0; 15.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CC-486 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Celgene
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved a Complete or Partial Response According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) Based on an Independent Radiology Assessment (IRA) |
0; 15.0 | — |
| PRIMARY Kaplan Meier Estimate of Progression-Free Survival (PFS) Based on an Independent Radiology Assessment According to RECIST 1.1 Criteria |
6.2; 4.4 | — |
| SECONDARY Kaplan Meier Estimate of Overall Survival |
18.0; NA | — |
| SECONDARY Percentage of Participants With Stable Disease for ≥ 16 Weeks From the Date of the First Treatment, or CR or PR According to RECIST 1.1 Criteria and Based on an Independent Radiology Assessment |
60.0; 50.0 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events |
6; 30; 6; 28; 4; 12 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration Of CC-486 (AUC-t) |
390.0; 351.7; 130.3; 461.3 | — |
| SECONDARY Area Under the Plasma Concentration -Time Curve From 0 Extrapolated to Infinity (AUC-inf, AUC0-∞) Of CC-486 |
392.5; 354.9; 138.0; 466.0 | — |
| SECONDARY Maximum Observed Concentration (Cmax) Of CC-486 |
266.3; 170.7; 102.7; 287.0 | — |
| SECONDARY Time to Reach Maximum Concentration (Tmax) Of CC-486 |
1.0; 1.3; 1.0; 1.0 | — |
| SECONDARY Terminal Half-Life (t1/2) of CC-486 |
0.562; 0.635; 0.584; 0.640 | — |
| SECONDARY Apparent Total Clearance (CL/F) Of CC-486 |
509.5; 845.3; 1450; 643.7 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) Of CC-486 |
412.9; 774.6; 1221; 594.8 | — |
Summary
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.
Eligibility 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 1-2 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.
Data sourced from ClinicalTrials.gov (NCT02269943). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.