Safety and Efficacy of CC-486 in Previously Treated Patients With Locally Advanced or Metastatic Nasopharyngeal Carcinoma
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 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. |
Drug: CC-486
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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) [Tumor response was assessed every (Q) 6 weeks for the first 3 evaluations then Q 9 weeks until disease progression as of the cut-off date of 08 August 2017; the median duration of treatment was 257 days for the 200 mg dose and 114.5 days for 300 mg dose]
Overall response rate was defined as the combined incidence of Complete Response (CR) or Partial Response (PR), confirmed no less than 4 weeks after the criteria for response were first met, based on independent radiology assessment according to RECIST 1.1 criteria. Complete response was defined as the disappearance of all target lesions and non-target lesions; Partial response is at least a 30% decrease from baseline in the sum of diameters of target lesions with no progression of non-target lesions and no new lesions or disappearance of target lesions with persistence of one or more non-target lesions from baseline.
- Kaplan Meier Estimate of Progression-Free Survival (PFS) Based on an Independent Radiology Assessment According to RECIST 1.1 Criteria [From Day 1 of documented disease progression; up to data cut off date of 08 August 2017; median follow-up time for censored participants was 12.3 months]
PFS was defined as the time from the date of start of the study treatment to the date of disease progression or death (any cause) on or prior to the data cut-off date for the statistical analysis, whichever occurred earlier, based on an independent radiology assessment of response using RECIST v1.1 criteria. Progressive disease was defined as at least a 20% increase in the sum of diameters of target or non-target lesions from nadir or appearance of a new lesion.
Secondary Outcome Measures
- Kaplan Meier Estimate of Overall Survival [From Day 1 of study treatment to the first date of progressive disease or death; up to data cut-off date of 08 August 2017; overall median follow-up time for censored participants was 20.4 months]
Overall survival was the time from the first dose of study drug to patient death from any cause. Participants who did not die were censored at the last known time the patient was alive date or the clinical data cutoff date, whichever was earlier.
- 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 [Tumor response was assessed every 6 weeks for the first 3 evaluations then every 9 weeks until disease progression. As of the cut-off date of 08 August 2017 the median duration of treatment was 257 days for the 200 mg dose and 114.5 days for 300 mg dose]
Disease Control Rate (DCR) was defined as the percentage of participants with a CR, PR, confirmed ≥ 4 weeks after the criteria for response were first met, or stable disease for ≥ 16 weeks from the first treatment, based on independent radiology assessment using RECIST 1.1 criteria. A complete response was defined as the disappearance of all target lesions and non-target lesions; a partial response is at least a 30% decrease from baseline in the sum of diameters of target lesions with no progression of non-target lesions and no new lesions or disappearance of target lesions with persistence of one or more non-target lesions from baseline. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease
- Number of Participants With Treatment Emergent Adverse Events [From date of first dose of study treatment to 28 days after last dose of study treatment; up to final data cut-off date of 08 August 2017; median treatment duration was 257 days for CC-486 200 mg and 114.5 days for CC-486 300 mg]
Treatment-emergent adverse events (TEAEs) were defined as any adverse event (AE) or serious adverse event (SAE) that occurred or worsened on or after the day of the first dose of the investigational product (IP) through 28 days after the last dose of IP. In addition, any SAE with an onset date more than 28 day after the last dose of IP that was assessed by the investigator as related to IP was considered a TEAE. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and based on the following scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death.
- Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration Of CC-486 (AUC-t) [Blood samples for oral azacitidine PK assessment were collected prior to each dose (pre-dose) and over the 8-hour period following each dose (0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose or similar schedule).]
Area under the plasma concentration-time curve from Time 0 to the time of the last quantifiable concentration, calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.
- Area Under the Plasma Concentration -Time Curve From 0 Extrapolated to Infinity (AUC-inf, AUC0-∞) Of CC-486 [Blood samples for oral azacitidine PK assessment were collected prior to each dose (pre-dose) and over the 8-hour period following each dose (0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose or similar schedule).]
Area under the plasma concentration-time curve from Time 0 extrapolated to infinity, calculated as [AUCt + Ct/ λz]. Ct is the last quantifiable concentration. No AUC extrapolation was performed with unreliable λz. If AUC %Extrap was ≥25%, AUC inf was not reported.
- Maximum Observed Concentration (Cmax) Of CC-486 [Blood samples for oral azacitidine PK assessment were collected prior to each dose (pre-dose) and over the 8-hour period following each dose (0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose or similar schedule).]
Maximum observed plasma concentration, obtained directly from the observed concentration versus time data.
- Time to Reach Maximum Concentration (Tmax) Of CC-486 [Blood samples for oral azacitidine PK assessment were collected prior to each dose (pre-dose) and over the 8-hour period following each dose (0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose or similar schedule).]
Time to Cmax, obtained directly from the observed concentration versus time data.
- Terminal Half-Life (t1/2) of CC-486 [Blood samples for oral azacitidine PK assessment were collected prior to each dose (pre-dose) and over the 8-hour period following each dose (0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose or similar schedule).]
Terminal phase half-life in plasma, calculated as [(ln 2)/λz]. t1/2 was only calculated when a reliable estimate for λz could be obtained.
- Apparent Total Clearance (CL/F) Of CC-486 [Blood samples for oral azacitidine PK assessment were collected prior to each dose (pre-dose) and over the 8-hour period following each dose (0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose or similar schedule).]
Apparent volume of distribution, calculated as [(CL/F)/λz].
- Apparent Volume of Distribution (Vz/F) Of CC-486 [Blood samples for oral azacitidine PK assessment were collected prior to each dose (pre-dose) and over the 8-hour period following each dose (0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose or similar schedule).]
Apparent volume of distribution, calculated as [(CL/F)/λz].
Eligibility Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Winship Cancer Institute of Emory University | Atlanta | Georgia | United States | 30322 |
2 | University of Chicago | Chicago | Illinois | United States | 60637 |
3 | Dana Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
4 | Columbia Comprehensive Cancer Care Clinic | Jefferson City | Missouri | United States | 65101 |
5 | Levine Cancer Institute | Charlotte | North Carolina | United States | 28204 |
6 | Princess Margaret Cancer Centre | Toronto | Ontario | Canada | M5G 2M9 |
7 | McGill University | Montreal | Quebec | Canada | H2W 1S6 |
8 | Institut Hospitalier Franco-Britannique | Levallois-Perret | France | 92300 | |
9 | Institut Curie | Paris | France | 75005 | |
10 | Institut Gustave Roussy | Villejuif Cedex | France | 94805 | |
11 | University General Hospital of Heraklion | Heraklion | Greece | 71110 | |
12 | Thermi Clinic | Thessaloniki | Greece | 56429 | |
13 | Istituto Nazionale Dei Tumori | Milano | Italy | 20133 | |
14 | National Cancer Center | Singapore | Singapore | 169-610 | |
15 | Singapore Oncology Consultants | Singapore | Singapore | 258500 | |
16 | Johns Hopkins Singapore International Medical Centre | Singapore | Singapore | 308433 | |
17 | Instituto Catalan de Oncologia-Hospital Duran | Barcelona | Spain | 08907 | |
18 | Hospital Universitario Madrid Sanchinarro | Madrid | Spain | 28050 | |
19 | Hospital Universitario de Salamanca | Salamanca | Spain | 37007 | |
20 | Chang Gung Medical Foundation, Kaohsiung Memorial Hospital | Niao-Sung Hsiang Kaohsiung County | Taiwan | 83301 | |
21 | China Medical University Hospital | Taichung | Taiwan | 40447 | |
22 | Taichung Veterans General Hospital | Taichung | Taiwan | 40705 | |
23 | Hopital Abderrahman Mami de Pneumo-Phtisiologie de l'Ariana | Ariana | Tunisia | 2080 | |
24 | Institut Salah Azaiez | Bab Saadoun | Tunisia | 1006 | |
25 | Hospital Habib Bourguiba | Sfax | Tunisia | 3029 |
Sponsors and Collaborators
- Celgene
Investigators
- Study Director: Abderahim (Rahim) Fandi, MD, PhD, Celgene
Study Documents (Full-Text)
- Study Protocol: CC-486-NPC-001_original protocol_Redacted.11July2014 - Jul 11, 2014
- Study Protocol: CC-486-NPC-001.01.protocolAM1_RedactedOctober2014 - Oct 1, 2014
- Study Protocol: CC-486-NPC-001_protocolAM2_Redacted.03April2015 - Apr 3, 2015
- Study Protocol: CC-486-NPC-001_protocolAM3_Redacted.23September2016 - Sep 23, 2016
- Statistical Analysis Plan - May 15, 2017
More Information
Publications
None provided.- CC-486-NPC-001
- 2014-001745-25
Study Results
Participant Flow
Recruitment Details | This was a multicenter study with 17 sites from the United States, Canada, France. Greece, Italy, Spain, Taiwan, Singapore and Tunisia. |
---|---|
Pre-assignment Detail | Participants were enrolled according to a Simon 2-stage design. The first 6 participants of Asian-Pacific Island ethnicity received 200 mg/day CC-486 on days 1-14 of each 21-day cycle to monitor safety and tolerability; if there were no safety concerns, subsequent participants of Asian-Pacific Island ethnicity would receive the 300 mg daily dose |
Arm/Group Title | CC-486 200 mg | CC-486 300 mg |
---|---|---|
Arm/Group Description | Asian-Pacific island participants received CC-486 200 mg tablets by mouth (PO) on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event, a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. If well tolerated, and there were no safety concerns, subsequent participants of Asian-Pacific Island ethnicity were administered CC-486 300-mg PO daily for 14 days of a 21-day cycle. | Participants received CC-486 300 mg tablets by mouth on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event (AE), a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. |
Period Title: Treatment Period | ||
STARTED | 6 | 30 |
Investigational Product (IP) Stopped | 6 | 30 |
COMPLETED | 0 | 0 |
NOT COMPLETED | 6 | 30 |
Period Title: Treatment Period | ||
STARTED | 5 | 26 |
COMPLETED | 0 | 0 |
NOT COMPLETED | 5 | 26 |
Baseline Characteristics
Arm/Group Title | CC-486 200 mg | CC-486 300 mg | Total |
---|---|---|---|
Arm/Group Description | Asian-Pacific island participants received CC-486 200 mg tablets by mouth (PO) on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event, a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. If well tolerated, and there were no safety concerns, subsequent participants of Asian-Pacific Island ethnicity were administered CC-486 300-mg PO daily for 14 days of a 21-day cycle. | Participants received CC-486 300 mg tablets by mouth on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event (AE), a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. | Total of all reporting groups |
Overall Participants | 6 | 30 | 36 |
Age (Years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [Years] |
53.2
(11.70)
|
52.2
(11.60)
|
52.4
(11.46)
|
Sex: Female, Male (Count of Participants) | |||
Female |
2
33.3%
|
5
16.7%
|
7
19.4%
|
Male |
4
66.7%
|
25
83.3%
|
29
80.6%
|
Race/Ethnicity, Customized (Count of Participants) | |||
Asian |
6
100%
|
7
23.3%
|
13
36.1%
|
White |
0
0%
|
23
76.7%
|
23
63.9%
|
Race/Ethnicity, Customized (Count of Participants) | |||
Hispanic |
0
0%
|
0
0%
|
0
0%
|
Non-Hispanic or Latino |
6
100%
|
30
100%
|
36
100%
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (Count of Participants) | |||
0 = Fully Active |
4
66.7%
|
11
36.7%
|
15
41.7%
|
1 = Restrictive but ambulatory |
2
33.3%
|
18
60%
|
20
55.6%
|
2 = Ambulatory but unable to work |
0
0%
|
1
3.3%
|
1
2.8%
|
3 = Limited Self-Care |
0
0%
|
0
0%
|
0
0%
|
Time From Initial Diagnosis to First Dose (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
3.60
(3.204)
|
3.86
(3.358)
|
3.81
(3.287)
|
Nasopharyngeal Cancer (NPC) Diagnosis Types (Count of Participants) | |||
Undifferentiated Nasopharyngeal Carcinoma |
2
33.3%
|
21
70%
|
23
63.9%
|
Poorly Differentiated Nasopharyngeal Carcinoma |
2
33.3%
|
9
30%
|
11
30.6%
|
Other |
2
33.3%
|
0
0%
|
2
5.6%
|
Participants with Prior Anti-Cancer Therapies (Count of Participants) | |||
Count of Participants [Participants] |
6
100%
|
29
96.7%
|
35
97.2%
|
Outcome Measures
Title | 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) |
---|---|
Description | Overall response rate was defined as the combined incidence of Complete Response (CR) or Partial Response (PR), confirmed no less than 4 weeks after the criteria for response were first met, based on independent radiology assessment according to RECIST 1.1 criteria. Complete response was defined as the disappearance of all target lesions and non-target lesions; Partial response is at least a 30% decrease from baseline in the sum of diameters of target lesions with no progression of non-target lesions and no new lesions or disappearance of target lesions with persistence of one or more non-target lesions from baseline. |
Time Frame | Tumor response was assessed every (Q) 6 weeks for the first 3 evaluations then Q 9 weeks until disease progression as of the cut-off date of 08 August 2017; the median duration of treatment was 257 days for the 200 mg dose and 114.5 days for 300 mg dose |
Outcome Measure Data
Analysis Population Description |
---|
The Efficacy Evaluable Population included all enrolled participants who met eligibility criteria and either received 2 cycles of CC-486 at any dose and discontinued treatment for progressive disease or received 4 cycles of CC-486 and had a baseline and at least 2 post-screening tumor assessments. |
Arm/Group Title | CC-486 200 mg | CC-486 300 mg |
---|---|---|
Arm/Group Description | Asian-Pacific island participants received CC-486 200 mg tablets by mouth (PO) on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event, a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. If well tolerated, and there were no safety concerns, subsequent participants of Asian-Pacific Island ethnicity were administered CC-486 300-mg PO daily for 14 days of a 21-day cycle. | Participants received CC-486 300 mg tablets by mouth on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event (AE), a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. |
Measure Participants | 5 | 20 |
Number (90% Confidence Interval) [percentage of participants] |
0
0%
|
15.0
50%
|
Title | Kaplan Meier Estimate of Progression-Free Survival (PFS) Based on an Independent Radiology Assessment According to RECIST 1.1 Criteria |
---|---|
Description | PFS was defined as the time from the date of start of the study treatment to the date of disease progression or death (any cause) on or prior to the data cut-off date for the statistical analysis, whichever occurred earlier, based on an independent radiology assessment of response using RECIST v1.1 criteria. Progressive disease was defined as at least a 20% increase in the sum of diameters of target or non-target lesions from nadir or appearance of a new lesion. |
Time Frame | From Day 1 of documented disease progression; up to data cut off date of 08 August 2017; median follow-up time for censored participants was 12.3 months |
Outcome Measure Data
Analysis Population Description |
---|
The Efficacy Evaluable Population included all enrolled participants who met eligibility criteria and either received 2 cycles of CC-486 at any dose and discontinued treatment for progressive disease or received 4 cycles of CC-486 and had a baseline and at least 2 post-screening tumor assessments. |
Arm/Group Title | CC-486 200 mg | CC-486 300 mg |
---|---|---|
Arm/Group Description | Asian-Pacific island participants received CC-486 200 mg tablets by mouth (PO) on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event, a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. If well tolerated, and there were no safety concerns, subsequent participants of Asian-Pacific Island ethnicity were administered CC-486 300-mg PO daily for 14 days of a 21-day cycle. | Participants received CC-486 300 mg tablets by mouth on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event (AE), a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. |
Measure Participants | 5 | 20 |
Median (90% Confidence Interval) [months] |
6.2
|
4.4
|
Title | Kaplan Meier Estimate of Overall Survival |
---|---|
Description | Overall survival was the time from the first dose of study drug to patient death from any cause. Participants who did not die were censored at the last known time the patient was alive date or the clinical data cutoff date, whichever was earlier. |
Time Frame | From Day 1 of study treatment to the first date of progressive disease or death; up to data cut-off date of 08 August 2017; overall median follow-up time for censored participants was 20.4 months |
Outcome Measure Data
Analysis Population Description |
---|
The Efficacy Evaluable Population included all enrolled participants who met eligibility criteria and either received 2 cycles of CC-486 at any dose and discontinued treatment for progressive disease or received 4 cycles of CC-486 and had a baseline and at least 2 post-screening tumor assessments. |
Arm/Group Title | CC-486 200 mg | CC-486 300 mg |
---|---|---|
Arm/Group Description | Asian-Pacific island participants received CC-486 200 mg tablets by mouth (PO) on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event, a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. If well tolerated, and there were no safety concerns, subsequent participants of Asian-Pacific Island ethnicity were administered CC-486 300-mg PO daily for 14 days of a 21-day cycle. | Participants received CC-486 300 mg tablets by mouth on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event (AE), a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. |
Measure Participants | 5 | 20 |
Median (90% Confidence Interval) [months] |
18.0
|
NA
|
Title | 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 |
---|---|
Description | Disease Control Rate (DCR) was defined as the percentage of participants with a CR, PR, confirmed ≥ 4 weeks after the criteria for response were first met, or stable disease for ≥ 16 weeks from the first treatment, based on independent radiology assessment using RECIST 1.1 criteria. A complete response was defined as the disappearance of all target lesions and non-target lesions; a partial response is at least a 30% decrease from baseline in the sum of diameters of target lesions with no progression of non-target lesions and no new lesions or disappearance of target lesions with persistence of one or more non-target lesions from baseline. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease |
Time Frame | Tumor response was assessed every 6 weeks for the first 3 evaluations then every 9 weeks until disease progression. As of the cut-off date of 08 August 2017 the median duration of treatment was 257 days for the 200 mg dose and 114.5 days for 300 mg dose |
Outcome Measure Data
Analysis Population Description |
---|
Efficacy Evaluable Population = enrolled participants who met eligibility criteria and either received 2 cycles of IP at any dose and discontinued treatment for progressive disease or received 4 cycles of IP and had at least 2 post-screening tumor exams. |
Arm/Group Title | CC-486 200 mg | CC-486 300 mg |
---|---|---|
Arm/Group Description | Asian-Pacific island participants received CC-486 200 mg tablets by mouth (PO) on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event, a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. If well tolerated, and there were no safety concerns, subsequent participants of Asian-Pacific Island ethnicity were administered CC-486 300-mg PO daily for 14 days of a 21-day cycle. | Participants received CC-486 300 mg tablets by mouth on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event (AE), a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. |
Measure Participants | 5 | 20 |
Median (90% Confidence Interval) [percentage of participants] |
60.0
1000%
|
50.0
166.7%
|
Title | Number of Participants With Treatment Emergent Adverse Events |
---|---|
Description | Treatment-emergent adverse events (TEAEs) were defined as any adverse event (AE) or serious adverse event (SAE) that occurred or worsened on or after the day of the first dose of the investigational product (IP) through 28 days after the last dose of IP. In addition, any SAE with an onset date more than 28 day after the last dose of IP that was assessed by the investigator as related to IP was considered a TEAE. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and based on the following scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death. |
Time Frame | From date of first dose of study treatment to 28 days after last dose of study treatment; up to final data cut-off date of 08 August 2017; median treatment duration was 257 days for CC-486 200 mg and 114.5 days for CC-486 300 mg |
Outcome Measure Data
Analysis Population Description |
---|
The Safety Population included all participants who received at least 1 dose of IP. |
Arm/Group Title | CC-486 200 mg | CC-486 300 mg |
---|---|---|
Arm/Group Description | Asian-Pacific island participants received CC-486 200 mg tablets by mouth (PO) on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event, a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. If well tolerated, and there were no safety concerns, subsequent participants of Asian-Pacific Island ethnicity were administered CC-486 300-mg PO daily for 14 days of a 21-day cycle. | Participants received CC-486 300 mg tablets by mouth on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event (AE), a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. |
Measure Participants | 6 | 30 |
Any TEAE |
6
100%
|
30
100%
|
Any TEAE Related to IP |
6
100%
|
28
93.3%
|
Any Serious TEAE |
4
66.7%
|
12
40%
|
Any Serious TEAE Related to IP |
3
50%
|
7
23.3%
|
Any CTCAE Grade 3 or 4 TEAE |
6
100%
|
20
66.7%
|
Any CTCAE Grade 3 or 4 TEAE Related to IP |
6
100%
|
16
53.3%
|
Any TEAE Leading to Death |
1
16.7%
|
1
3.3%
|
Any TEAE Leading to Dose Reduction |
5
83.3%
|
9
30%
|
Any TEAE Leading to Drug Interruption |
4
66.7%
|
9
30%
|
Any TEAE Leading to IP Discontinuation |
1
16.7%
|
10
33.3%
|
Title | Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration Of CC-486 (AUC-t) |
---|---|
Description | Area under the plasma concentration-time curve from Time 0 to the time of the last quantifiable concentration, calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing. |
Time Frame | Blood samples for oral azacitidine PK assessment were collected prior to each dose (pre-dose) and over the 8-hour period following each dose (0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose or similar schedule). |
Outcome Measure Data
Analysis Population Description |
---|
The PK population includes participants with evaluable CC-486 plasma PK profiles. |
Arm/Group Title | CC-486 200 mg | CC-486 300 mg |
---|---|---|
Arm/Group Description | Asian-Pacific island participants received CC-486 200 mg tablets by mouth (PO) on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event, a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. If well tolerated, and there were no safety concerns, subsequent participants of Asian-Pacific Island ethnicity were administered CC-486 300-mg PO daily for 14 days of a 21-day cycle. | Participants received CC-486 300 mg tablets by mouth on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event (AE), a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. |
Measure Participants | 6 | 7 |
Cycle 1 Day 1 |
390.0
(58.8)
|
351.7
(87.5)
|
Cycle 1 Day 14 |
130.3
(995.5)
|
461.3
(104.2)
|
Title | Area Under the Plasma Concentration -Time Curve From 0 Extrapolated to Infinity (AUC-inf, AUC0-∞) Of CC-486 |
---|---|
Description | Area under the plasma concentration-time curve from Time 0 extrapolated to infinity, calculated as [AUCt + Ct/ λz]. Ct is the last quantifiable concentration. No AUC extrapolation was performed with unreliable λz. If AUC %Extrap was ≥25%, AUC inf was not reported. |
Time Frame | Blood samples for oral azacitidine PK assessment were collected prior to each dose (pre-dose) and over the 8-hour period following each dose (0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose or similar schedule). |
Outcome Measure Data
Analysis Population Description |
---|
The PK population includes participants with evaluable CC-486 plasma PK profiles. |
Arm/Group Title | CC-486 200 mg | CC-486 300 mg |
---|---|---|
Arm/Group Description | Asian-Pacific island participants received CC-486 200 mg tablets by mouth (PO) on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event, a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. If well tolerated, and there were no safety concerns, subsequent participants of Asian-Pacific Island ethnicity were administered CC-486 300-mg PO daily for 14 days of a 21-day cycle. | Participants received CC-486 300 mg tablets by mouth on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event (AE), a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. |
Measure Participants | 6 | 7 |
Cycle 1 Day 1 |
392.5
(58.3)
|
354.9
(87.1)
|
Cycle 1 Day 14 |
138.0
(802.1)
|
466.0
(104.7)
|
Title | Maximum Observed Concentration (Cmax) Of CC-486 |
---|---|
Description | Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. |
Time Frame | Blood samples for oral azacitidine PK assessment were collected prior to each dose (pre-dose) and over the 8-hour period following each dose (0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose or similar schedule). |
Outcome Measure Data
Analysis Population Description |
---|
The PK population includes participants with evaluable CC-486 plasma PK profiles |
Arm/Group Title | CC-486 200 mg | CC-486 300 mg |
---|---|---|
Arm/Group Description | Asian-Pacific island participants received CC-486 200 mg tablets by mouth (PO) on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event, a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. If well tolerated, and there were no safety concerns, subsequent participants of Asian-Pacific Island ethnicity were administered CC-486 300-mg PO daily for 14 days of a 21-day cycle. | Participants received CC-486 300 mg tablets by mouth on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event (AE), a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. |
Measure Participants | 6 | 7 |
Cycle 1 Day 1 |
266.3
(53.8)
|
170.7
(95.0)
|
Cycle 1 Day 14 |
102.7
(412.0)
|
287.0
(50.7)
|
Title | Time to Reach Maximum Concentration (Tmax) Of CC-486 |
---|---|
Description | Time to Cmax, obtained directly from the observed concentration versus time data. |
Time Frame | Blood samples for oral azacitidine PK assessment were collected prior to each dose (pre-dose) and over the 8-hour period following each dose (0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose or similar schedule). |
Outcome Measure Data
Analysis Population Description |
---|
The PK population includes participants with evaluable CC-486 plasma PK profiles. |
Arm/Group Title | CC-486 200 mg | CC-486 300 mg |
---|---|---|
Arm/Group Description | Asian-Pacific island participants received CC-486 200 mg tablets by mouth (PO) on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event, a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. If well tolerated, and there were no safety concerns, subsequent participants of Asian-Pacific Island ethnicity were administered CC-486 300-mg PO daily for 14 days of a 21-day cycle. | Participants received CC-486 300 mg tablets by mouth on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event (AE), a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. |
Measure Participants | 6 | 7 |
Cycle 1 Day 1 |
1.0
|
1.3
|
Cycle 1 Day 14 |
1.0
|
1.0
|
Title | Terminal Half-Life (t1/2) of CC-486 |
---|---|
Description | Terminal phase half-life in plasma, calculated as [(ln 2)/λz]. t1/2 was only calculated when a reliable estimate for λz could be obtained. |
Time Frame | Blood samples for oral azacitidine PK assessment were collected prior to each dose (pre-dose) and over the 8-hour period following each dose (0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose or similar schedule). |
Outcome Measure Data
Analysis Population Description |
---|
The PK population includes participants with evaluable CC-486 plasma PK profiles. |
Arm/Group Title | CC-486 200 mg | CC-486 300 mg |
---|---|---|
Arm/Group Description | Asian-Pacific island participants received CC-486 200 mg tablets by mouth (PO) on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event, a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. If well tolerated, and there were no safety concerns, subsequent participants of Asian-Pacific Island ethnicity were administered CC-486 300-mg PO daily for 14 days of a 21-day cycle. | Participants received CC-486 300 mg tablets by mouth on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event (AE), a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. |
Measure Participants | 6 | 7 |
Cycle 1 Day 1 |
0.562
(23.1)
|
0.635
(24.2)
|
Cycle 1 Day 14 |
0.584
(17.2)
|
0.640
(32.0)
|
Title | Apparent Total Clearance (CL/F) Of CC-486 |
---|---|
Description | Apparent volume of distribution, calculated as [(CL/F)/λz]. |
Time Frame | Blood samples for oral azacitidine PK assessment were collected prior to each dose (pre-dose) and over the 8-hour period following each dose (0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose or similar schedule). |
Outcome Measure Data
Analysis Population Description |
---|
The PK population includes participants with evaluable CC-486 plasma PK profiles. |
Arm/Group Title | CC-486 200 mg | CC-486 300 mg |
---|---|---|
Arm/Group Description | Asian-Pacific island participants received CC-486 200 mg tablets by mouth (PO) on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event, a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. If well tolerated, and there were no safety concerns, subsequent participants of Asian-Pacific Island ethnicity were administered CC-486 300-mg PO daily for 14 days of a 21-day cycle. | Participants received CC-486 300 mg tablets by mouth on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event (AE), a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. |
Measure Participants | 6 | 7 |
Cycle 1 Day 1 |
509.5
(58.3)
|
845.3
(87.1)
|
Cycle 1 Day 14 |
1450
(802.1)
|
643.7
(104.7)
|
Title | Apparent Volume of Distribution (Vz/F) Of CC-486 |
---|---|
Description | Apparent volume of distribution, calculated as [(CL/F)/λz]. |
Time Frame | Blood samples for oral azacitidine PK assessment were collected prior to each dose (pre-dose) and over the 8-hour period following each dose (0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose or similar schedule). |
Outcome Measure Data
Analysis Population Description |
---|
The PK population includes participants with evaluable CC-486 plasma PK profiles. |
Arm/Group Title | CC-486 200 mg | CC-486 300 mg |
---|---|---|
Arm/Group Description | Asian-Pacific island participants received CC-486 200 mg tablets by mouth (PO) on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event, a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. If well tolerated, and there were no safety concerns, subsequent participants of Asian-Pacific Island ethnicity were administered CC-486 300-mg PO daily for 14 days of a 21-day cycle. | Participants received CC-486 300 mg tablets by mouth on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event (AE), a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. |
Measure Participants | 6 | 7 |
Cycle 1 Day 1 |
412.9
(42.9)
|
774.6
(78.6)
|
Cycle 1 Day 14 |
1221
(581.3)
|
594.8
(69.7)
|
Adverse Events
Time Frame | From Day 1 of study treatment until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter that are suspected of being related to IP; up to final cut-off date of 08 August 2017; median duration of study treatment was 257 days for CC-486 200 mg and 114.5 days for CC-486 300 mg. | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | CC-486 200 mg | CC-486 300 mg | ||
Arm/Group Description | Asian-Pacific island participants received CC-486 200 mg tablets by mouth (PO) on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event, a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. If well tolerated, and there were no safety concerns, subsequent participants of Asian-Pacific Island ethnicity were administered CC-486 300-mg PO daily for 14 days of a 21-day cycle. | Participants received CC-486 300 mg tablets by mouth on days 1-14 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, adverse event (AE), a new anticancer therapy is begun, withdrawal of consent, subject refusal, physician decision, or death. | ||
All Cause Mortality |
||||
CC-486 200 mg | CC-486 300 mg | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 4/6 (66.7%) | 18/30 (60%) | ||
Serious Adverse Events |
||||
CC-486 200 mg | CC-486 300 mg | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 4/6 (66.7%) | 12/30 (40%) | ||
Blood and lymphatic system disorders | ||||
Febrile neutropenia | 2/6 (33.3%) | 2/30 (6.7%) | ||
Neutropenia | 0/6 (0%) | 1/30 (3.3%) | ||
Congenital, familial and genetic disorders | ||||
Tracheo-oesophageal fistula | 0/6 (0%) | 1/30 (3.3%) | ||
Eye disorders | ||||
Cataract | 0/6 (0%) | 1/30 (3.3%) | ||
Gastrointestinal disorders | ||||
Dysphagia | 0/6 (0%) | 2/30 (6.7%) | ||
Nausea | 0/6 (0%) | 1/30 (3.3%) | ||
Vomiting | 0/6 (0%) | 2/30 (6.7%) | ||
General disorders | ||||
Asthenia | 0/6 (0%) | 1/30 (3.3%) | ||
Fatigue | 0/6 (0%) | 1/30 (3.3%) | ||
Pyrexia | 1/6 (16.7%) | 1/30 (3.3%) | ||
Infections and infestations | ||||
Pneumonia | 0/6 (0%) | 1/30 (3.3%) | ||
Septic shock | 1/6 (16.7%) | 0/30 (0%) | ||
Investigations | ||||
Neutrophil count decreased | 2/6 (33.3%) | 0/30 (0%) | ||
Metabolism and nutrition disorders | ||||
Hypernatraemia | 0/6 (0%) | 1/30 (3.3%) | ||
Musculoskeletal and connective tissue disorders | ||||
Muscular weakness | 0/6 (0%) | 1/30 (3.3%) | ||
Nervous system disorders | ||||
Brain oedema | 1/6 (16.7%) | 0/30 (0%) | ||
Cerebrovascular accident | 1/6 (16.7%) | 1/30 (3.3%) | ||
Hypoaesthesia | 0/6 (0%) | 1/30 (3.3%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
Epistaxis | 0/6 (0%) | 1/30 (3.3%) | ||
Other (Not Including Serious) Adverse Events |
||||
CC-486 200 mg | CC-486 300 mg | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 6/6 (100%) | 29/30 (96.7%) | ||
Blood and lymphatic system disorders | ||||
Anaemia | 1/6 (16.7%) | 5/30 (16.7%) | ||
Leukopenia | 0/6 (0%) | 4/30 (13.3%) | ||
Neutropenia | 3/6 (50%) | 9/30 (30%) | ||
Thrombocytopenia | 1/6 (16.7%) | 3/30 (10%) | ||
Cardiac disorders | ||||
Sinus tachycardia | 1/6 (16.7%) | 0/30 (0%) | ||
Ear and labyrinth disorders | ||||
Deafness unilateral | 1/6 (16.7%) | 0/30 (0%) | ||
Ear pain | 0/6 (0%) | 2/30 (6.7%) | ||
Endocrine disorders | ||||
Diabetes insipidus | 1/6 (16.7%) | 0/30 (0%) | ||
Eye disorders | ||||
Eye oedema | 1/6 (16.7%) | 0/30 (0%) | ||
Gastrointestinal disorders | ||||
Abdominal distension | 1/6 (16.7%) | 1/30 (3.3%) | ||
Abdominal pain | 1/6 (16.7%) | 1/30 (3.3%) | ||
Abdominal pain upper | 1/6 (16.7%) | 3/30 (10%) | ||
Constipation | 1/6 (16.7%) | 10/30 (33.3%) | ||
Dental caries | 1/6 (16.7%) | 0/30 (0%) | ||
Diarrhoea | 3/6 (50%) | 10/30 (33.3%) | ||
Dyspepsia | 1/6 (16.7%) | 0/30 (0%) | ||
Dysphagia | 0/6 (0%) | 4/30 (13.3%) | ||
Inguinal hernia | 1/6 (16.7%) | 0/30 (0%) | ||
Nausea | 6/6 (100%) | 18/30 (60%) | ||
Oesophagitis | 0/6 (0%) | 2/30 (6.7%) | ||
Stomatitis | 2/6 (33.3%) | 4/30 (13.3%) | ||
Toothache | 1/6 (16.7%) | 0/30 (0%) | ||
Vomiting | 3/6 (50%) | 23/30 (76.7%) | ||
General disorders | ||||
Asthenia | 0/6 (0%) | 8/30 (26.7%) | ||
Face oedema | 0/6 (0%) | 2/30 (6.7%) | ||
Facial pain | 0/6 (0%) | 2/30 (6.7%) | ||
Fatigue | 3/6 (50%) | 5/30 (16.7%) | ||
Hypothermia | 1/6 (16.7%) | 0/30 (0%) | ||
Non-cardiac chest pain | 0/6 (0%) | 2/30 (6.7%) | ||
Oedema peripheral | 1/6 (16.7%) | 0/30 (0%) | ||
Pyrexia | 1/6 (16.7%) | 8/30 (26.7%) | ||
Infections and infestations | ||||
Bacteraemia | 1/6 (16.7%) | 0/30 (0%) | ||
Diverticulitis | 1/6 (16.7%) | 0/30 (0%) | ||
Ear infection | 1/6 (16.7%) | 1/30 (3.3%) | ||
Nasopharyngitis | 0/6 (0%) | 2/30 (6.7%) | ||
Nosocomial infection | 1/6 (16.7%) | 0/30 (0%) | ||
Oral candidiasis | 1/6 (16.7%) | 1/30 (3.3%) | ||
Pneumonia | 1/6 (16.7%) | 1/30 (3.3%) | ||
Respiratory tract infection | 1/6 (16.7%) | 0/30 (0%) | ||
Sinusitis | 0/6 (0%) | 2/30 (6.7%) | ||
Skin infection | 1/6 (16.7%) | 0/30 (0%) | ||
Upper respiratory tract infection | 1/6 (16.7%) | 0/30 (0%) | ||
Injury, poisoning and procedural complications | ||||
Humerus fracture | 1/6 (16.7%) | 0/30 (0%) | ||
Investigations | ||||
Alanine aminotransferase increased | 1/6 (16.7%) | 5/30 (16.7%) | ||
Aspartate aminotransferase increased | 1/6 (16.7%) | 2/30 (6.7%) | ||
Blood alkaline phosphatase increased | 1/6 (16.7%) | 2/30 (6.7%) | ||
Blood creatinine increased | 1/6 (16.7%) | 1/30 (3.3%) | ||
C-reactive protein increased | 0/6 (0%) | 2/30 (6.7%) | ||
Neutrophil count decreased | 1/6 (16.7%) | 1/30 (3.3%) | ||
Weight decreased | 0/6 (0%) | 5/30 (16.7%) | ||
Metabolism and nutrition disorders | ||||
Decreased appetite | 2/6 (33.3%) | 8/30 (26.7%) | ||
Hyperammonaemia | 1/6 (16.7%) | 0/30 (0%) | ||
Hyperglycaemia | 1/6 (16.7%) | 2/30 (6.7%) | ||
Hyperkalaemia | 0/6 (0%) | 3/30 (10%) | ||
Hypoalbuminaemia | 1/6 (16.7%) | 1/30 (3.3%) | ||
Hypocalcaemia | 1/6 (16.7%) | 1/30 (3.3%) | ||
Hypoglycaemia | 1/6 (16.7%) | 0/30 (0%) | ||
Hypokalaemia | 1/6 (16.7%) | 3/30 (10%) | ||
Hypomagnesaemia | 1/6 (16.7%) | 5/30 (16.7%) | ||
Hyponatraemia | 0/6 (0%) | 3/30 (10%) | ||
Metabolic acidosis | 1/6 (16.7%) | 0/30 (0%) | ||
Musculoskeletal and connective tissue disorders | ||||
Arthralgia | 2/6 (33.3%) | 1/30 (3.3%) | ||
Back pain | 1/6 (16.7%) | 4/30 (13.3%) | ||
Musculoskeletal chest pain | 1/6 (16.7%) | 2/30 (6.7%) | ||
Neck pain | 1/6 (16.7%) | 3/30 (10%) | ||
Nervous system disorders | ||||
Dizziness | 1/6 (16.7%) | 3/30 (10%) | ||
Dysgeusia | 0/6 (0%) | 2/30 (6.7%) | ||
Facial paralysis | 0/6 (0%) | 2/30 (6.7%) | ||
Headache | 1/6 (16.7%) | 2/30 (6.7%) | ||
Hypoaesthesia | 0/6 (0%) | 2/30 (6.7%) | ||
Neuropathy peripheral | 1/6 (16.7%) | 0/30 (0%) | ||
Syncope | 1/6 (16.7%) | 0/30 (0%) | ||
Psychiatric disorders | ||||
Anxiety | 1/6 (16.7%) | 3/30 (10%) | ||
Insomnia | 1/6 (16.7%) | 2/30 (6.7%) | ||
Reproductive system and breast disorders | ||||
Menstrual disorder | 1/6 (16.7%) | 0/30 (0%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
Cough | 1/6 (16.7%) | 6/30 (20%) | ||
Dysphonia | 0/6 (0%) | 2/30 (6.7%) | ||
Nasal congestion | 1/6 (16.7%) | 0/30 (0%) | ||
Pleural effusion | 1/6 (16.7%) | 1/30 (3.3%) | ||
Productive cough | 1/6 (16.7%) | 0/30 (0%) | ||
Rhinorrhoea | 1/6 (16.7%) | 0/30 (0%) | ||
Skin and subcutaneous tissue disorders | ||||
Decubitus ulcer | 1/6 (16.7%) | 0/30 (0%) | ||
Pain of skin | 1/6 (16.7%) | 0/30 (0%) | ||
Pruritus | 0/6 (0%) | 3/30 (10%) | ||
Pruritus generalised | 1/6 (16.7%) | 0/30 (0%) | ||
Rash maculo-papular | 1/6 (16.7%) | 0/30 (0%) | ||
Vascular disorders | ||||
Hypotension | 1/6 (16.7%) | 0/30 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results from a center cannot be submitted for publication before results of multicenter study are published unless it is more than 1 year from study completion. Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 additional days. Investigator must delete confidential information before submission or defer publication to permit patent applications.
Results Point of Contact
Name/Title | Anne McClain, Senior Manager, Clinical Trial Disclosure |
---|---|
Organization | Celgene Corporation |
Phone | 888-260-1599 |
ClinicalTrialDisclosure@celgene.com |
- CC-486-NPC-001
- 2014-001745-25