SIGNATURE: LGX818 for Patients With BRAFV600 Mutated Tumors
Sponsor
Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT01981187
Collaborator
(none)
12
13
1
20.9
0.9
0
Study Details
Study Description
Brief Summary
The purpose of this signal seeking study is to determine whether treatment with LGX818 demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Primary Purpose:
Treatment
Official Title:
Modular Phase II Study to Link Targeted Therapy to Patients With Pathway Activated Tumors: Module 4 - LGX818 for Patients With BRAFV600 Mutated Tumors
Actual Study Start Date
:
Jan 14, 2014
Actual Primary Completion Date
:
Sep 1, 2015
Actual Study Completion Date
:
Oct 13, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LGX818 LGX818 will be dosed on a flat scale of 300 mg (e.g., 3 x 100 mg capsules) once daily on a continuous dosing cycle. A complete treatment cycle is defined as 28 days. There will be no breaks between dosing cycles. |
Drug: LGX818
LGX818 will be dosed on a flat scale of 300 mg (e.g., 3 x 100 mg capsules) once daily on a continuous dosing cycle. A complete treatment cycle is defined as 28 days. There will be no breaks between dosing cycles.
|
Outcome Measures
Primary Outcome Measures
- Clinical Benefit Rate (CBR) for Solid Tumors as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [Up to 13.3 months]
CBR for solid tumors was defined as percentage of participants with complete response (CR) or partial response (PR), or stable disease (SD) for greater than or equal to (>=) 16 weeks. As per RECIST v1.1, CR was defined as disappearance of all target and non-target lesions and normalization of tumor markers. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline.
Secondary Outcome Measures
- Overall Response Rate (ORR) for Solid Tumors as Per RECIST Version 1.1 [From the first dose study treatment until the first documented CR or PR (maximum up to 13.3 months)]
ORR for solid tumors was defined as the percentage of participants achieving an overall best response of CR or PR as assessed per RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor markers. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as least a 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- Progression-Free Survival (PFS) for Solid Tumors as Per RECIST Version 1.1 [From the date of first dose until the first documentation of PD, relapse, censored date or death, whichever occurred first (maximum up to 13.3 months)]
PFS for solid tumors was defined as the time from the date of first dose of study drug to the date of first documented disease progression (PD) or relapse or death due to any cause within 30 days of the last dose. PD was defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. Participants who had no event were censored at the date of last adequate tumor assessment.
- Overall Survival (OS) for Solid Tumors [From date of the first dose until the date of death, censored date (maximum up to 13.3 months)]
OS for solid tumors was defined as the time from the date of first dose of study drug to the date of death due to any cause. For participants who were alive at the time of analysis, the data was censored at the date of last contact.
- Duration of Response (DOR) for Solid Tumors as Per RECIST Version 1.1 [From first documentation of response to first documentation of PD or relapse or death (maximum up to 13.3 months)]
DOR for solid tumors was defined as the time from the first documented response (CR or PR) to the date of first documented PD or relapse or death due to any cause, whichever occurred first. As per RECIST v1.1, CR was defined as disappearance of all target and non-target lesions and normalization of tumor markers. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as least a 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 [Screening up to 30 days after the last dose of study treatment (maximum up to 13.3 months)]
Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms, clinical/diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local/noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe/medically significant but not immediately life-threatening, hospitalization/prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated. TEAE was defined as event with onset dates occurring during the on-treatment period. CTCAE Grade 5 (death) was not used in this study.
- Change From Baseline in Systolic and Diastolic Blood Pressure [Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 (each cycle of 28 days), and End of treatment (up to 7 days after study treatment discontinuation)]
Change from baseline in systolic and diastolic blood pressure in millimeter of mercury (mmHg) in sitting position was reported.
- Change From Baseline in Sitting Pulse Rate [Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 (each cycle of 28 days), and End of treatment (up to 7 days after study treatment discontinuation)]
Change from baseline in pulse rate in beats per minute (bpm) in sitting position was reported.
- Change From Baseline in Body Temperature [Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 (each cycle of 28 days), and End of treatment (up to 7 days after study treatment discontinuation)]
Change from baseline in body temperature in degree Celsius was reported.
- Change From Baseline in Respiratory Rate [Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 (each cycle of 28 days), and End of treatment (up to 7 days after study treatment discontinuation)]
Change from baseline in respiratory rate in breaths per minute was reported.
- Change From Baseline in Body Weight [Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 (each cycle of 28 days), and End of treatment (up to 7 days after study treatment discontinuation)]
Change from baseline in body weight in kilogram (Kg) was reported
- Number of Participants With Shifts From Baseline in Hematology and Serum Chemistry Laboratory Abnormalities [Baseline up to maximum of 30 days after the last dose of study treatment (up to 13.3 months)]
Number of participants with shifts from baseline in hematology and serum chemistry laboratory parameters, were graded and reported as low, normal and high as assessed by Common terminology criteria for adverse events (CTCAE) v4.03. 'Low' refers to participants with values that were below lower limit of normal with no observation above the upper limit of normal; 'High' refers to participants with values that were above the upper limit of normal with no observation below the lower limit of normal; 'Low and High' refers to participants with values that were below the lower limit of normal and values that were above the upper limit of normal.
- Change From Baseline in QT Interval Corrected According to the Formula of Fridericia (QTcF), QT, QRS, and PR Duration [Baseline, Day 15 of Cycle 1, 2, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 (each cycle of 28 days), and End of treatment (up to 7 days after study treatment discontinuation)]
Change from baseline in QTcF, QT, QRS, and PR duration were reported. QT interval is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole. QRS interval is the time from electrocardiogram Q wave to the end of the S wave, corresponding to ventricle depolarization. PR interval is the time between the beginning of the P wave and the start of the QRS interval, corresponding to the end of atrial depolarization and onset of ventricular depolarization.
- Change From Baseline in Heart Rate [Baseline, Day 15 of Cycle 1, 2, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 (each cycle of 28 days), and End of treatment (up to 7 days after study treatment discontinuation)]
Change from baseline in heart rate in terms of beats per minute was reported.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria
-
Patient has a confirmed diagnosis of a select solid tumor (except with a primary diagnosis of melanoma and colorectal cancer (CRC)) or hematologic malignancies and is in need of treatment because of progression or relapse.
-
Patient's tumor has been evaluated and pre-identified as having a tumor with a BRAFV600 mutation at a CLIA certified laboratory.
-
Patient must have received at least one prior treatment for recurrent, metastatic and /or locally advanced disease and for whom no standard therapy options are anticipated to result in a durable remission.
-
Patient must have progressive and measurable disease per RECIST 1.1. or other appropriate hematological response criteria.
-
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Exclusion Criteria:
-
Patient has received prior treatment with LGX818.
-
Patients with Central Nerve System (CNS) metastasis or leptomeningeal carcinomatosis.
-
Patient has received chemotherapy or other anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to starting study drug.
-
Patients with acute or chronic pancreatitis.
-
Patients with impaired cardiac function or clinically significant cardiac diseases.
-
Patients with another primary malignancy within 3 years prior to starting study treatment, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alabama Oncology St. Vincent's Birmingham | Birmingham | Alabama | United States | 35211 |
| 2 | Highlands Oncology Group Highlands Oncology Group (22) | Fayetteville | Arkansas | United States | 72703 |
| 3 | Yale University School of Medicine Smilow Cancer Hospital | New Haven | Connecticut | United States | 06520 |
| 4 | Whittingham Cancer Center Norwalk Hospital | Norwalk | Connecticut | United States | 06856 |
| 5 | Florida Cancer Specialists Florida Cancer Specialists (31 | Fort Myers | Florida | United States | 33901 |
| 6 | Lurie Children's Hospital of Chicago Developmental Therapeutics | Chicago | Illinois | United States | 60611 |
| 7 | Comprehensive Cancer Centers of Nevada CCC of Nevada (1) | Las Vegas | Nevada | United States | 89109 |
| 8 | Genesis Cancer Services | Zanesville | Ohio | United States | 43701 |
| 9 | University of Pennsylvania Presbyterian Medical Center University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 10 | Sanford Research Sanford Health | Sioux Falls | South Dakota | United States | 57104 |
| 11 | Oncology Consultants Oncology Group | Houston | Texas | United States | 77024 |
| 12 | Utah Cancer Specialists Utah Cancer Specialists (11) | Salt Lake City | Utah | United States | 84106 |
| 13 | Shenandoah Oncology Shenadoah Oncology (2) | Winchester | Virginia | United States | 22601 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01981187
Other Study ID Numbers:
- CLGX818AUS03
- C4221021
First Posted:
Nov 11, 2013
Last Update Posted:
Mar 26, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | LGX818 (Encorafenib) |
|---|---|
| Arm/Group Description | Participants received an oral dose of 300 mg of LGX818 (Encorafenib) capsules (3 capsules of 100 mg) once daily in each cycle (1 cycle = 28 days) until disease progression, unacceptable toxicity, death or discontinuation from study treatment for any other reason. Maximum study treatment exposure was approximately of 12 months and participants were followed up to 13.3 months approximately. |
| Period Title: Overall Study | |
| STARTED | 12 |
| COMPLETED | 0 |
| NOT COMPLETED | 12 |
Baseline Characteristics
| Arm/Group Title | LGX818 (Encorafenib) |
|---|---|
| Arm/Group Description | Participants received an oral dose of 300 mg of LGX818 (Encorafenib) capsules (3 capsules of 100 mg) once daily in each cycle (1 cycle = 28 days) until disease progression, unacceptable toxicity, death or discontinuation from study treatment for any other reason. Maximum study treatment exposure was approximately of 12 months and participants were followed up to 13.3 months approximately. |
| Overall Participants | 12 |
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
57.6
(11.17)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
7
58.3%
|
| Male |
5
41.7%
|
Outcome Measures
| Title | Clinical Benefit Rate (CBR) for Solid Tumors as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 |
|---|---|
| Description | CBR for solid tumors was defined as percentage of participants with complete response (CR) or partial response (PR), or stable disease (SD) for greater than or equal to (>=) 16 weeks. As per RECIST v1.1, CR was defined as disappearance of all target and non-target lesions and normalization of tumor markers. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. |
| Time Frame | Up to 13.3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set included all participants who received at least one dose of study drug. |
| Arm/Group Title | LGX818 (Encorafenib) |
|---|---|
| Arm/Group Description | Participants received an oral dose of 300 mg of LGX818 (Encorafenib) capsules (3 capsules of 100 mg) once daily in each cycle (1 cycle = 28 days) until disease progression, unacceptable toxicity, death or discontinuation from study treatment for any other reason. Maximum study treatment exposure was approximately of 12 months and participants were followed up to 13.3 months approximately. |
| Measure Participants | 12 |
| Number (95% Confidence Interval) [percentage of participants] |
25
208.3%
|
| Title | Overall Response Rate (ORR) for Solid Tumors as Per RECIST Version 1.1 |
|---|---|
| Description | ORR for solid tumors was defined as the percentage of participants achieving an overall best response of CR or PR as assessed per RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor markers. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as least a 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Time Frame | From the first dose study treatment until the first documented CR or PR (maximum up to 13.3 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set included all participants who received at least one dose of study drug. |
| Arm/Group Title | LGX818 (Encorafenib) |
|---|---|
| Arm/Group Description | Participants received an oral dose of 300 mg of LGX818 (Encorafenib) capsules (3 capsules of 100 mg) once daily in each cycle (1 cycle = 28 days) until disease progression, unacceptable toxicity, death or discontinuation from study treatment for any other reason. Maximum study treatment exposure was approximately of 12 months and participants were followed up to 13.3 months approximately. |
| Measure Participants | 12 |
| Number (95% Confidence Interval) [percentage of participants] |
0
0%
|
| Title | Progression-Free Survival (PFS) for Solid Tumors as Per RECIST Version 1.1 |
|---|---|
| Description | PFS for solid tumors was defined as the time from the date of first dose of study drug to the date of first documented disease progression (PD) or relapse or death due to any cause within 30 days of the last dose. PD was defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. Participants who had no event were censored at the date of last adequate tumor assessment. |
| Time Frame | From the date of first dose until the first documentation of PD, relapse, censored date or death, whichever occurred first (maximum up to 13.3 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set included all participants who received at least one dose of study drug. |
| Arm/Group Title | LGX818 (Encorafenib) |
|---|---|
| Arm/Group Description | Participants received an oral dose of 300 mg of LGX818 (Encorafenib) capsules (3 capsules of 100 mg) once daily in each cycle (1 cycle = 28 days) until disease progression, unacceptable toxicity, death or discontinuation from study treatment for any other reason. Maximum study treatment exposure was approximately of 12 months and participants were followed up to 13.3 months approximately. |
| Measure Participants | 12 |
| Median (95% Confidence Interval) [months] |
NA
|
| Title | Overall Survival (OS) for Solid Tumors |
|---|---|
| Description | OS for solid tumors was defined as the time from the date of first dose of study drug to the date of death due to any cause. For participants who were alive at the time of analysis, the data was censored at the date of last contact. |
| Time Frame | From date of the first dose until the date of death, censored date (maximum up to 13.3 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set included all participants who received at least one dose of study drug. |
| Arm/Group Title | LGX818 (Encorafenib) |
|---|---|
| Arm/Group Description | Participants received an oral dose of 300 mg of LGX818 (Encorafenib) capsules (3 capsules of 100 mg) once daily in each cycle (1 cycle = 28 days) until disease progression, unacceptable toxicity, death or discontinuation from study treatment for any other reason. Maximum study treatment exposure was approximately of 12 months and participants were followed up to 13.3 months approximately. |
| Measure Participants | 12 |
| Median (Full Range) [months] |
13.3
|
| Title | Duration of Response (DOR) for Solid Tumors as Per RECIST Version 1.1 |
|---|---|
| Description | DOR for solid tumors was defined as the time from the first documented response (CR or PR) to the date of first documented PD or relapse or death due to any cause, whichever occurred first. As per RECIST v1.1, CR was defined as disappearance of all target and non-target lesions and normalization of tumor markers. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as least a 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Time Frame | From first documentation of response to first documentation of PD or relapse or death (maximum up to 13.3 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data for this outcome measure was not analyzed due to low overall response rate among participants. |
| Arm/Group Title | LGX818 (Encorafenib) |
|---|---|
| Arm/Group Description | Participants received an oral dose of 300 mg of LGX818 (Encorafenib) capsules (3 capsules of 100 mg) once daily in each cycle (1 cycle = 28 days) until disease progression, unacceptable toxicity, death or discontinuation from study treatment for any other reason. Maximum study treatment exposure was approximately of 12 months and participants were followed up to 13.3 months approximately. |
| Measure Participants | 0 |
| Title | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 |
|---|---|
| Description | Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms, clinical/diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local/noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe/medically significant but not immediately life-threatening, hospitalization/prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated. TEAE was defined as event with onset dates occurring during the on-treatment period. CTCAE Grade 5 (death) was not used in this study. |
| Time Frame | Screening up to 30 days after the last dose of study treatment (maximum up to 13.3 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety set included all participants who received at least one dose of study treatment and had at least one post-baseline safety assessment. |
| Arm/Group Title | LGX818 (Encorafenib) |
|---|---|
| Arm/Group Description | Participants received an oral dose of 300 mg of LGX818 (Encorafenib) capsules (3 capsules of 100 mg) once daily in each cycle (1 cycle = 28 days) until disease progression, unacceptable toxicity, death or discontinuation from study treatment for any other reason. Maximum study treatment exposure was approximately of 12 months and participants were followed up to 13.3 months approximately. |
| Measure Participants | 12 |
| Grade 1 |
0
0%
|
| Grade 2 |
2
16.7%
|
| Grade 3 |
10
83.3%
|
| Grade 4 |
0
0%
|
| Title | Change From Baseline in Systolic and Diastolic Blood Pressure |
|---|---|
| Description | Change from baseline in systolic and diastolic blood pressure in millimeter of mercury (mmHg) in sitting position was reported. |
| Time Frame | Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 (each cycle of 28 days), and End of treatment (up to 7 days after study treatment discontinuation) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety set included all participants who received at least one dose of study treatment and had at least one post-baseline safety assessment. Here 'number analyzed' signifies number of participants evaluable for each specified row. |
| Arm/Group Title | LGX818 (Encorafenib) |
|---|---|
| Arm/Group Description | Participants received an oral dose of 300 mg of LGX818 (Encorafenib) capsules (3 capsules of 100 mg) once daily in each cycle (1 cycle = 28 days) until disease progression, unacceptable toxicity, death or discontinuation from study treatment for any other reason. Maximum study treatment exposure was approximately of 12 months and participants were followed up to 13.3 months approximately. |
| Measure Participants | 12 |
| Systolic Blood Pressure: Baseline |
129.4
(17.33)
|
| Systolic Blood Pressure: Change at Cycle 2, Day 1 |
2.4
(4.34)
|
| Systolic Blood Pressure: Change at Cycle 3, Day 1 |
4.0
(23.56)
|
| Systolic Blood Pressure: Change at Cycle 4, Day 1 |
-0.3
(14.52)
|
| Systolic Blood Pressure: Change at Cycle 5, Day 1 |
7.8
(11.32)
|
| Systolic Blood Pressure: Change at Cycle 6, Day 1 |
-5.3
(18.01)
|
| Systolic Blood Pressure: Change at Cycle 7, Day 1 |
0.0
(12.49)
|
| Systolic Blood Pressure: Change at Cycle 8, Day 1 |
1.5
(4.95)
|
| Systolic Blood Pressure: Change at Cycle 9, Day 1 |
2.0
(NA)
|
| Systolic Blood Pressure: Change at Cycle 10, Day 1 |
9.0
(NA)
|
| Systolic Blood Pressure: Change at Cycle 11, Day 1 |
10.0
(NA)
|
| Systolic Blood Pressure: Change at Cycle 12, Day 1 |
15.0
(NA)
|
| Systolic Blood Pressure: Change at End of Treatment |
8.7
(18.95)
|
| Diastolic Blood Pressure: Baseline |
78.1
(9.33)
|
| Diastolic Blood Pressure: Change at Cycle 2, Day 1 |
-0.1
(8.46)
|
| Diastolic Blood Pressure: Change at Cycle 3, Day 1 |
1.4
(11.26)
|
| Diastolic Blood Pressure: Change at Cycle 4, Day 1 |
-1.3
(5.62)
|
| Diastolic Blood Pressure: Change at Cycle 5, Day 1 |
-0.5
(4.12)
|
| Diastolic Blood Pressure: Change at Cycle 6, Day 1 |
-0.7
(8.33)
|
| Diastolic Blood Pressure: Change at Cycle 7, Day 1 |
1.7
(9.71)
|
| Diastolic Blood Pressure: Change at Cycle 8, Day 1 |
1.0
(4.24)
|
| Diastolic Blood Pressure: Change at Cycle 9, Day 1 |
0.0
(NA)
|
| Diastolic Blood Pressure: Change at Cycle 10, Day 1 |
9.0
(NA)
|
| Diastolic Blood Pressure: Change at Cycle 11, Day 1 |
5.0
(NA)
|
| Diastolic Blood Pressure: Change at Cycle 12, Day 1 |
0.0
(NA)
|
| Diastolic Blood Pressure: Change at End of Treatment |
4.7
(12.12)
|
| Title | Change From Baseline in Sitting Pulse Rate |
|---|---|
| Description | Change from baseline in pulse rate in beats per minute (bpm) in sitting position was reported. |
| Time Frame | Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 (each cycle of 28 days), and End of treatment (up to 7 days after study treatment discontinuation) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety set included all participants who received at least one dose of study treatment and had at least one post-baseline safety assessment. Here 'number analyzed' signifies number of participants evaluable for each specified row. |
| Arm/Group Title | LGX818 (Encorafenib) |
|---|---|
| Arm/Group Description | Participants received an oral dose of 300 mg of LGX818 (Encorafenib) capsules (3 capsules of 100 mg) once daily in each cycle (1 cycle = 28 days) until disease progression, unacceptable toxicity, death or discontinuation from study treatment for any other reason. Maximum study treatment exposure was approximately of 12 months and participants were followed up to 13.3 months approximately. |
| Measure Participants | 12 |
| Baseline |
84.8
(18.17)
|
| Change at Cycle 2, Day 1 |
4.9
(8.18)
|
| Change at Cycle 3, Day 1 |
-1.2
(18.67)
|
| Change at Cycle 4, Day 1 |
-19.0
(23.86)
|
| Change at Cycle 5, Day 1 |
-5.0
(4.24)
|
| Change at Cycle 6, Day 1 |
-10.3
(8.33)
|
| Change at Cycle 7, Day 1 |
-4.3
(16.86)
|
| Change at Cycle 8, Day 1 |
-1.0
(42.43)
|
| Change at Cycle 9, Day 1 |
-24.0
(NA)
|
| Change at Cycle 10, Day 1 |
-25.0
(NA)
|
| Change at Cycle 11, Day 1 |
-19.0
(NA)
|
| Change at Cycle 12, Day 1 |
-23.0
(NA)
|
| Change at End of Treatment |
-2.7
(9.33)
|
| Title | Change From Baseline in Body Temperature |
|---|---|
| Description | Change from baseline in body temperature in degree Celsius was reported. |
| Time Frame | Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 (each cycle of 28 days), and End of treatment (up to 7 days after study treatment discontinuation) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety set included all participants who received at least one dose of study treatment and had at least one post-baseline safety assessment. Here 'number analyzed' signifies number of participants evaluable for each specified row. |
| Arm/Group Title | LGX818 (Encorafenib) |
|---|---|
| Arm/Group Description | Participants received an oral dose of 300 mg of LGX818 (Encorafenib) capsules (3 capsules of 100 mg) once daily in each cycle (1 cycle = 28 days) until disease progression, unacceptable toxicity, death or discontinuation from study treatment for any other reason. Maximum study treatment exposure was approximately of 12 months and participants were followed up to 13.3 months approximately. |
| Measure Participants | 12 |
| Baseline |
36.7
(0.30)
|
| Change at Cycle 2, Day 1 |
-0.1
(0.32)
|
| Change at Cycle 3, Day 1 |
0.0
(0.25)
|
| Change at Cycle 4, Day 1 |
-0.3
(0.13)
|
| Change at Cycle 5, Day 1 |
0.0
(0.13)
|
| Change at Cycle 6, Day 1 |
-0.4
(0.36)
|
| Change at Cycle 7, Day 1 |
-0.4
(0.42)
|
| Change at Cycle 8, Day 1 |
-0.4
(0.42)
|
| Change at Cycle 9, Day 1 |
-0.5
(NA)
|
| Change at Cycle 10, Day 1 |
-0.5
(NA)
|
| Change at Cycle 11, Day 1 |
-0.8
(NA)
|
| Change at Cycle 12, Day 1 |
-0.4
(NA)
|
| Change at End of Treatment |
-0.1
(0.38)
|
| Title | Change From Baseline in Respiratory Rate |
|---|---|
| Description | Change from baseline in respiratory rate in breaths per minute was reported. |
| Time Frame | Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 (each cycle of 28 days), and End of treatment (up to 7 days after study treatment discontinuation) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety set included all participants who received at least one dose of study treatment and had at least one post-baseline safety assessment. Here 'number analyzed' signifies number of participants evaluable for each specified row. |
| Arm/Group Title | LGX818 (Encorafenib) |
|---|---|
| Arm/Group Description | Participants received an oral dose of 300 mg of LGX818 (Encorafenib) capsules (3 capsules of 100 mg) once daily in each cycle (1 cycle = 28 days) until disease progression, unacceptable toxicity, death or discontinuation from study treatment for any other reason. Maximum study treatment exposure was approximately of 12 months and participants were followed up to 13.3 months approximately. |
| Measure Participants | 12 |
| Baseline |
17.6
(1.31)
|
| Change at Cycle 2, Day 1 |
0.0
(1.41)
|
| Change at Cycle 3, Day 1 |
2.0
(4.47)
|
| Change at Cycle 4, Day 1 |
-1.0
(1.15)
|
| Change at Cycle 5, Day 1 |
-0.5
(1.00)
|
| Change at Cycle 6, Day 1 |
0.0
(2.00)
|
| Change at Cycle 7, Day 1 |
0.7
(1.15)
|
| Change at Cycle 8, Day 1 |
-1.0
(1.41)
|
| Change at Cycle 9, Day 1 |
0.0
(NA)
|
| Change at Cycle 10, Day 1 |
0.0
(NA)
|
| Change at Cycle 11, Day 1 |
0.0
(NA)
|
| Change at Cycle 12, Day 1 |
1.0
(NA)
|
| Change at End of Treatment |
-0.1
(1.76)
|
| Title | Change From Baseline in Body Weight |
|---|---|
| Description | Change from baseline in body weight in kilogram (Kg) was reported |
| Time Frame | Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 (each cycle of 28 days), and End of treatment (up to 7 days after study treatment discontinuation) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety set included all participants who received at least one dose of study treatment and had at least one post-baseline safety assessment. Here 'number analyzed' signifies number of participants evaluable for each specified row. |
| Arm/Group Title | LGX818 (Encorafenib) |
|---|---|
| Arm/Group Description | Participants received an oral dose of 300 mg of LGX818 (Encorafenib) capsules (3 capsules of 100 mg) once daily in each cycle (1 cycle = 28 days) until disease progression, unacceptable toxicity, death or discontinuation from study treatment for any other reason. Maximum study treatment exposure was approximately of 12 months and participants were followed up to 13.3 months approximately. |
| Measure Participants | 12 |
| Baseline |
87.0
(21.77)
|
| Change at Cycle 2, Day 1 |
-3.4
(2.48)
|
| Change at Cycle 3, Day 1 |
-3.4
(2.77)
|
| Change at Cycle 4, Day 1 |
-6.5
(3.85)
|
| Change at Cycle 5, Day 1 |
-5.8
(3.96)
|
| Change at Cycle 6, Day 1 |
-6.0
(4.57)
|
| Change at Cycle 7, Day 1 |
-6.8
(5.96)
|
| Change at Cycle 8, Day 1 |
-6.4
(4.81)
|
| Change at Cycle 9, Day 1 |
-12.5
(NA)
|
| Change at Cycle 10, Day 1 |
-10.3
(NA)
|
| Change at Cycle 11, Day 1 |
-9.4
(NA)
|
| Change at Cycle 12, Day 1 |
-9.0
(NA)
|
| Change at End of Treatment |
-3.7
(3.43)
|
| Title | Number of Participants With Shifts From Baseline in Hematology and Serum Chemistry Laboratory Abnormalities |
|---|---|
| Description | Number of participants with shifts from baseline in hematology and serum chemistry laboratory parameters, were graded and reported as low, normal and high as assessed by Common terminology criteria for adverse events (CTCAE) v4.03. 'Low' refers to participants with values that were below lower limit of normal with no observation above the upper limit of normal; 'High' refers to participants with values that were above the upper limit of normal with no observation below the lower limit of normal; 'Low and High' refers to participants with values that were below the lower limit of normal and values that were above the upper limit of normal. |
| Time Frame | Baseline up to maximum of 30 days after the last dose of study treatment (up to 13.3 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety set included all participants who received at least one dose of study treatment and had at least one post-baseline safety assessment. Here 'number analyzed' signifies number of participants evaluable for each specified row. |
| Arm/Group Title | LGX818 (Encorafenib) |
|---|---|
| Arm/Group Description | Participants received an oral dose of 300 mg of LGX818 (Encorafenib) capsules (3 capsules of 100 mg) once daily in each cycle (1 cycle = 28 days) until disease progression, unacceptable toxicity, death or discontinuation from study treatment for any other reason. Maximum study treatment exposure was approximately of 12 months and participants were followed up to 13.3 months approximately. |
| Measure Participants | 12 |
| Red Blood Cell Count, Low |
5
41.7%
|
| Red Blood Cell Count, Normal |
6
50%
|
| Red Blood Cell Count, High |
0
0%
|
| Hematocrit, Low |
7
58.3%
|
| Hematocrit, Normal |
4
33.3%
|
| Hematocrit, High |
0
0%
|
| Eosinophils, Low |
0
0%
|
| Eosinophils, Normal |
7
58.3%
|
| Eosinophils, High |
3
25%
|
| Basophils, Low |
0
0%
|
| Basophils, Normal |
9
75%
|
| Basophils, High |
1
8.3%
|
| Monocytes, Low |
0
0%
|
| Monocytes, Normal |
3
25%
|
| Monocytes, High |
7
58.3%
|
| Neutrophils, Low |
0
0%
|
| Neutrophils, Normal |
0
0%
|
| Neutrophils, High |
1
8.3%
|
| Lymphocytes, Low |
0
0%
|
| Lymphocytes, Normal |
1
8.3%
|
| Lymphocytes, High |
0
0%
|
| Blood Urea Nitrogen, Low |
1
8.3%
|
| Blood Urea Nitrogen, Normal |
8
66.7%
|
| Blood Urea Nitrogen, High |
2
16.7%
|
| Bicarbonate, Low |
2
16.7%
|
| Bicarbonate, Normal |
7
58.3%
|
| Bicarbonate, High |
2
16.7%
|
| Lactate Dehydrogenase, Low |
1
8.3%
|
| Lactate Dehydrogenase, Normal |
7
58.3%
|
| Lactate Dehydrogenase, High |
2
16.7%
|
| Serum Total Protein, Low |
3
25%
|
| Serum Total Protein, Normal |
8
66.7%
|
| Serum Total Protein, High |
0
0%
|
| Low-Density Lipoprotein, Low |
1
8.3%
|
| Low-Density Lipoprotein, Normal |
2
16.7%
|
| Low-Density Lipoprotein, High |
7
58.3%
|
| High-Density Lipoprotein, Low |
6
50%
|
| High-Density Lipoprotein, Normal |
4
33.3%
|
| High-Density Lipoprotein, High |
0
0%
|
| Thyroid-Stimulating Hormone, Low |
2
16.7%
|
| Thyroid-Stimulating Hormone, Normal |
6
50%
|
| Thyroid-Stimulating Hormone, High |
1
8.3%
|
| T3, Low |
2
16.7%
|
| T3, Normal |
7
58.3%
|
| T3, High |
0
0%
|
| T4, Low |
1
8.3%
|
| T4, Normal |
7
58.3%
|
| T4, High |
1
8.3%
|
| Title | Change From Baseline in QT Interval Corrected According to the Formula of Fridericia (QTcF), QT, QRS, and PR Duration |
|---|---|
| Description | Change from baseline in QTcF, QT, QRS, and PR duration were reported. QT interval is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole. QRS interval is the time from electrocardiogram Q wave to the end of the S wave, corresponding to ventricle depolarization. PR interval is the time between the beginning of the P wave and the start of the QRS interval, corresponding to the end of atrial depolarization and onset of ventricular depolarization. |
| Time Frame | Baseline, Day 15 of Cycle 1, 2, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 (each cycle of 28 days), and End of treatment (up to 7 days after study treatment discontinuation) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety set included all participants who received at least one dose of study treatment and had at least one post-baseline safety assessment. Here 'number analyzed' signifies number of participants evaluable for each specified row. |
| Arm/Group Title | LGX818 (Encorafenib) |
|---|---|
| Arm/Group Description | Participants received an oral dose of 300 mg of LGX818 (Encorafenib) capsules (3 capsules of 100 mg) once daily in each cycle (1 cycle = 28 days) until disease progression, unacceptable toxicity, death or discontinuation from study treatment for any other reason. Maximum study treatment exposure was approximately of 12 months and participants were followed up to 13.3 months approximately. |
| Measure Participants | 12 |
| QTcF: Baseline |
423.9
(24.84)
|
| QTcF: Change at Cycle 1, Day 15 |
0.6
(16.11)
|
| QTcF: Change at Cycle 2, Day 1 |
3.1
(28.33)
|
| QTcF: Change at Cycle 2, Day 15 |
-62.0
(99.90)
|
| QTcF: Change at Cycle 3, Day 1 |
7.0
(14.30)
|
| QTcF: Change at Cycle 4, Day 1 |
1.3
(11.50)
|
| QTcF: Change at Cycle 5, Day 1 |
0.7
(1.53)
|
| QTcF: Change at Cycle 6, Day 1 |
-6.0
(9.17)
|
| QTcF: Change at Cycle 7, Day 1 |
-18.5
(6.36)
|
| QTcF: Change at Cycle 8, Day 1 |
-28.0
(NA)
|
| QTcF: Change at Cycle 9, Day 1 |
-36.0
(NA)
|
| QTcF: Change at Cycle 10, Day 1 |
-26.0
(NA)
|
| QTcF: Change at End of Treatment |
4.5
(25.69)
|
| QT: Baseline |
394.2
(36.19)
|
| QT: Change at Cycle 1, Day 15 |
-4.3
(18.27)
|
| QT: Change at Cycle 2, Day 1 |
-2.4
(29.47)
|
| QT: Change at Cycle 2, Day 15 |
-47.0
(79.97)
|
| QT: Change at Cycle 3, Day 1 |
6.6
(30.59)
|
| QT: Change at Cycle 4, Day 1 |
-6.7
(25.40)
|
| QT: Change at Cycle 5, Day 1 |
5.3
(11.02)
|
| QT: Change at Cycle 6, Day 1 |
-6.7
(24.68)
|
| QT: Change at Cycle 7, Day 1 |
-33.0
(29.70)
|
| QT: Change at Cycle 8, Day 1 |
-78.0
(NA)
|
| QT: Change at Cycle 9, Day 1 |
-29.0
(NA)
|
| QT: Change at Cycle 10, Day 1 |
-18.0
(NA)
|
| QT: Change at End of Treatment |
-0.3
(20.04)
|
| QRS: Baseline |
93.9
(12.75)
|
| QRS: Change at Cycle 1, Day 15 |
-2.3
(4.68)
|
| QRS: Change at Cycle 2, Day 1 |
-1.1
(13.50)
|
| QRS: Change at Cycle 2, Day 15 |
0.6
(6.31)
|
| QRS: Change at Cycle 3, Day 1 |
-2.4
(2.61)
|
| QRS: Change at Cycle 4, Day 1 |
-5.0
(3.61)
|
| QRS: Change at Cycle 5, Day 1 |
-3.3
(3.06)
|
| QRS: Change at Cycle 6, Day 1 |
0.0
(4.00)
|
| QRS: Change at Cycle 7, Day 1 |
-5.0
(1.41)
|
| QRS: Change at Cycle 8, Day 1 |
-8.0
(NA)
|
| QRS: Change at Cycle 9, Day 1 |
5.0
(NA)
|
| QRS: Change at Cycle 10, Day 1 |
6.0
(NA)
|
| QRS: Change at End of Treatment |
-6.1
(6.01)
|
| PR: Baseline |
145.8
(25.13)
|
| PR: Change at Cycle 1, Day 15 |
-7.3
(19.60)
|
| PR: Change at Cycle 2, Day 1 |
-7.4
(26.50)
|
| PR: Change at Cycle 2, Day 15 |
1.2
(11.37)
|
| PR: Change at Cycle 3, Day 1 |
-0.6
(19.59)
|
| PR: Change at Cycle 4, Day 1 |
-6.0
(2.00)
|
| PR: Change at Cycle 5, Day 1 |
7.3
(16.29)
|
| PR: Change at Cycle 6, Day 1 |
2.7
(21.39)
|
| PR: Change at Cycle 7, Day 1 |
10.0
(22.63)
|
| PR: Change at Cycle 8, Day 1 |
-14.0
(NA)
|
| PR: Change at Cycle 9, Day 1 |
-13.0
(NA)
|
| PR: Change at Cycle 10, Day 1 |
-8.0
(NA)
|
| PR: Change at End of Treatment |
-6.9
(21.96)
|
| Title | Change From Baseline in Heart Rate |
|---|---|
| Description | Change from baseline in heart rate in terms of beats per minute was reported. |
| Time Frame | Baseline, Day 15 of Cycle 1, 2, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 (each cycle of 28 days), and End of treatment (up to 7 days after study treatment discontinuation) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety set included all participants who received at least one dose of study treatment and had at least one post-baseline safety assessment. Here 'number analyzed' signifies number of participants evaluable for each specified row. |
| Arm/Group Title | LGX818 (Encorafenib) |
|---|---|
| Arm/Group Description | Participants received an oral dose of 300 mg of LGX818 (Encorafenib) capsules (3 capsules of 100 mg) once daily in each cycle (1 cycle = 28 days) until disease progression, unacceptable toxicity, death or discontinuation from study treatment for any other reason. Maximum study treatment exposure was approximately of 12 months and participants were followed up to 13.3 months approximately. |
| Measure Participants | 12 |
| Baseline |
77.3
(15.79)
|
| Change at Cycle 1, Day 15 |
2.9
(9.01)
|
| Change at Cycle 2, Day 1 |
4.1
(12.31)
|
| Change at Cycle 2, Day 15 |
-1.0
(9.30)
|
| Change at Cycle 3, Day 1 |
-0.4
(12.66)
|
| Change at Cycle 4, Day 1 |
7.3
(14.74)
|
| Change at Cycle 5, Day 1 |
-3.0
(5.29)
|
| Change at Cycle 6, Day 1 |
-0.7
(7.77)
|
| Change at Cycle 7, Day 1 |
7.0
(11.31)
|
| Change at Cycle 8, Day 1 |
27.0
(NA)
|
| Change at Cycle 9, Day 1 |
-2.0
(NA)
|
| Change at Cycle 10, Day 1 |
-4.0
(NA)
|
| Change at End of Treatment |
2.0
(10.68)
|
Adverse Events
| Time Frame | From screening up to 30 days after the last dose of study treatment (maximum up to 13.3 months) | |
|---|---|---|
| Adverse Event Reporting Description | Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may have experienced both SAE and non-SAE. The safety set included all participants who received at least one dose of study treatment and had at least one post-baseline safety assessment. | |
| Arm/Group Title | LGX818 (Encorafenib) | |
| Arm/Group Description | Participants received an oral dose of 300 mg of LGX818 (Encorafenib) capsules (3 capsules of 100 mg) once daily in each cycle (1 cycle = 28 days) until disease progression, unacceptable toxicity, death or discontinuation from study treatment for any other reason. Maximum study treatment exposure was approximately of 12 months and participants were followed up to 13.3 months approximately. | |
All Cause Mortality |
||
| LGX818 (Encorafenib) | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/12 (0%) | |
Serious Adverse Events |
||
| LGX818 (Encorafenib) | ||
| Affected / at Risk (%) | # Events | |
| Total | 4/12 (33.3%) | |
| Blood and lymphatic system disorders | ||
| Anaemia | 1/12 (8.3%) | |
| General disorders | ||
| Fatigue | 1/12 (8.3%) | |
| Metabolism and nutrition disorders | ||
| Dehydration | 1/12 (8.3%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Malignant melanoma | 1/12 (8.3%) | |
| Renal and urinary disorders | ||
| Acute kidney injury | 1/12 (8.3%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Pneumothorax | 1/12 (8.3%) | |
Other (Not Including Serious) Adverse Events |
||
| LGX818 (Encorafenib) | ||
| Affected / at Risk (%) | # Events | |
| Total | 12/12 (100%) | |
| Blood and lymphatic system disorders | ||
| Anaemia | 1/12 (8.3%) | |
| Lymphadenopathy | 1/12 (8.3%) | |
| Cardiac disorders | ||
| Palpitations | 2/12 (16.7%) | |
| Ear and labyrinth disorders | ||
| Ear pain | 1/12 (8.3%) | |
| Eye disorders | ||
| Conjunctival disorder | 1/12 (8.3%) | |
| Dry eye | 1/12 (8.3%) | |
| Eye irritation | 1/12 (8.3%) | |
| Eye pruritus | 1/12 (8.3%) | |
| Lacrimation increased | 1/12 (8.3%) | |
| Photophobia | 1/12 (8.3%) | |
| Vision blurred | 1/12 (8.3%) | |
| Gastrointestinal disorders | ||
| Nausea | 9/12 (75%) | |
| Vomiting | 7/12 (58.3%) | |
| Constipation | 4/12 (33.3%) | |
| Abdominal pain | 3/12 (25%) | |
| Diarrhoea | 3/12 (25%) | |
| Dyspepsia | 1/12 (8.3%) | |
| Gastric fistula | 1/12 (8.3%) | |
| Gastrooesophageal reflux disease | 1/12 (8.3%) | |
| Haematochezia | 1/12 (8.3%) | |
| Pancreatitis | 1/12 (8.3%) | |
| Retching | 1/12 (8.3%) | |
| General disorders | ||
| Fatigue | 7/12 (58.3%) | |
| Asthenia | 3/12 (25%) | |
| Influenza like illness | 2/12 (16.7%) | |
| Mucosal inflammation | 2/12 (16.7%) | |
| Oedema peripheral | 2/12 (16.7%) | |
| Axillary pain | 1/12 (8.3%) | |
| Chills | 1/12 (8.3%) | |
| Face oedema | 1/12 (8.3%) | |
| Nodule | 1/12 (8.3%) | |
| Pyrexia | 1/12 (8.3%) | |
| Infections and infestations | ||
| Oral candidiasis | 2/12 (16.7%) | |
| Urinary tract infection | 2/12 (16.7%) | |
| Candida infection | 1/12 (8.3%) | |
| Folliculitis | 1/12 (8.3%) | |
| Gastrointestinal infection | 1/12 (8.3%) | |
| Investigations | ||
| Electrocardiogram QT prolonged | 2/12 (16.7%) | |
| Weight decreased | 2/12 (16.7%) | |
| Blood creatine phosphokinase increased | 1/12 (8.3%) | |
| Blood creatinine decreased | 1/12 (8.3%) | |
| Blood creatinine increased | 1/12 (8.3%) | |
| Blood urea increased | 1/12 (8.3%) | |
| Gamma-glutamyltransferase increased | 1/12 (8.3%) | |
| International normalised ratio increased | 1/12 (8.3%) | |
| Lipase increased | 1/12 (8.3%) | |
| Prothrombin time prolonged | 1/12 (8.3%) | |
| Urine leukocyte esterase | 1/12 (8.3%) | |
| Metabolism and nutrition disorders | ||
| Decreased appetite | 3/12 (25%) | |
| Hyperglycaemia | 2/12 (16.7%) | |
| Dehydration | 1/12 (8.3%) | |
| Hyperlipidaemia | 1/12 (8.3%) | |
| Hyperphosphataemia | 1/12 (8.3%) | |
| Hyperuricaemia | 1/12 (8.3%) | |
| Hypocalcaemia | 1/12 (8.3%) | |
| Hypokalaemia | 1/12 (8.3%) | |
| Hyponatraemia | 1/12 (8.3%) | |
| Musculoskeletal and connective tissue disorders | ||
| Back pain | 5/12 (41.7%) | |
| Arthralgia | 4/12 (33.3%) | |
| Pain in extremity | 3/12 (25%) | |
| Myalgia | 2/12 (16.7%) | |
| Arthritis | 1/12 (8.3%) | |
| Bone pain | 1/12 (8.3%) | |
| Muscle spasms | 1/12 (8.3%) | |
| Musculoskeletal pain | 1/12 (8.3%) | |
| Neck pain | 1/12 (8.3%) | |
| Pain in jaw | 1/12 (8.3%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Neoplasm skin | 2/12 (16.7%) | |
| Seborrhoeic keratosis | 2/12 (16.7%) | |
| Dysplastic naevus | 1/12 (8.3%) | |
| Melanocytic naevus | 1/12 (8.3%) | |
| Nervous system disorders | ||
| Dizziness | 3/12 (25%) | |
| Headache | 2/12 (16.7%) | |
| Paraesthesia | 2/12 (16.7%) | |
| Dysaesthesia | 1/12 (8.3%) | |
| Narcolepsy | 1/12 (8.3%) | |
| Neuropathy peripheral | 1/12 (8.3%) | |
| Somnolence | 1/12 (8.3%) | |
| Psychiatric disorders | ||
| Depression | 2/12 (16.7%) | |
| Anxiety | 1/12 (8.3%) | |
| Insomnia | 1/12 (8.3%) | |
| Renal and urinary disorders | ||
| Acute kidney injury | 1/12 (8.3%) | |
| Glycosuria | 1/12 (8.3%) | |
| Haematuria | 1/12 (8.3%) | |
| Micturition urgency | 1/12 (8.3%) | |
| Proteinuria | 1/12 (8.3%) | |
| Reproductive system and breast disorders | ||
| Scrotal oedema | 1/12 (8.3%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Dyspnoea | 3/12 (25%) | |
| Pleural effusion | 2/12 (16.7%) | |
| Atelectasis | 1/12 (8.3%) | |
| Epistaxis | 1/12 (8.3%) | |
| Haemoptysis | 1/12 (8.3%) | |
| Skin and subcutaneous tissue disorders | ||
| Rash | 6/12 (50%) | |
| Pruritus | 5/12 (41.7%) | |
| Palmar-plantar erythrodysaesthesia syndrome | 4/12 (33.3%) | |
| Erythema | 3/12 (25%) | |
| Skin exfoliation | 3/12 (25%) | |
| Alopecia | 2/12 (16.7%) | |
| Dry skin | 2/12 (16.7%) | |
| Keratosis pilaris | 2/12 (16.7%) | |
| Acne | 1/12 (8.3%) | |
| Dermatitis | 1/12 (8.3%) | |
| Eczema | 1/12 (8.3%) | |
| Hyperkeratosis | 1/12 (8.3%) | |
| Lentigo | 1/12 (8.3%) | |
| Pain of skin | 1/12 (8.3%) | |
| Papule | 1/12 (8.3%) | |
| Pigmentation disorder | 1/12 (8.3%) | |
| Pruritus generalised | 1/12 (8.3%) | |
| Rash follicular | 1/12 (8.3%) | |
| Rash maculo-papular | 1/12 (8.3%) | |
| Skin burning sensation | 1/12 (8.3%) | |
| Skin discolouration | 1/12 (8.3%) | |
| Skin fissures | 1/12 (8.3%) | |
| Skin hyperpigmentation | 1/12 (8.3%) | |
| Skin hypopigmentation | 1/12 (8.3%) | |
| Skin lesion | 1/12 (8.3%) | |
| Skin tightness | 1/12 (8.3%) | |
| Vascular disorders | ||
| Deep vein thrombosis | 1/12 (8.3%) | |
| Hypertension | 1/12 (8.3%) | |
| Orthostatic hypotension | 1/12 (8.3%) | |
Limitations/Caveats
Due to slow enrollment and lack of response observed during the enrollment period, the Sponsor decided to close study enrollment early on 28 January 2015.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01981187
Other Study ID Numbers:
- CLGX818AUS03
- C4221021
First Posted:
Nov 11, 2013
Last Update Posted:
Mar 26, 2021
Last Verified:
Mar 1, 2021