A Phase 3 interventional study of Axitinib and Placebo in Clear Cell Renal Carcinoma, sponsored by SFJ Pharma Ltd. II. Terminated at 106 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-20.
Sponsored by SFJ Pharma Ltd. II · Phase 3, Interventional, and Prevention
The purpose of this trial is to determine if adjuvant therapy with axitinib will prevent or delay the recurrence of renal cell cancer after surgery to remove the primary tumor in high risk patients.
This is a prospective, randomized, double blind placebo controlled Phase 3 trial of oral axitinib starting at 5 mg twice daily given 3 years vs. placebo.
Approximately 700 patients will be randomized in a 1:1 ratio between axitinib vs placebo.
1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.
This study's enrollment of 724 is above the median of 42 across 1,480 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →This is the only study on the registry with SFJ Pharma Ltd. II as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients must be treated by nephrectomy and patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
Patients must be diagnosed with one of the following based on American Joint Committee on Cancer (AJCC) TNM staging version 2010, Eastern Collaborative Oncology Group (ECOG) performance status (PS):
Exclusion Criteria
Drug: Axitinib
Drug: Placebo
Axitinib 5 mg twice daily
Also known as: Inlyta
Placebo twice daily
Disease Free Survival (DFS) as Assessed by Blinded Independent Review Committee (IRC)
DFS is defined as time interval from the date of randomization to first date of recurrence/relapse (distant or local recurrence of \[RCC\] or occurrence of a secondary malignancy {occurrence of a second primary cancer other than RCC} or death). For participants with no DFS event, DFS was censored at date of last scan prior to time of analyses. Participants alive who did not have post-baseline disease assessments, DFS was censored at randomization. Participants who received further anti-tumor therapy prior to recurrence or occurrence of a secondary malignancy or death, DFS was censored on date of last scan prior to taking anti-tumor medication. Participants who missed 2 or more consecutive tumor scans immediately followed by an event were censored at date of last objective tumor assessment prior to missing/not readable scan.
Time frame: From randomization date up to first date of recurrence or the occurrence of a secondary malignancy or death (up to 5 years)
Overall Survival (OS)
OS defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. Participants lacking data beyond randomization had their survival times censored at randomization.
Time frame: From randomization date until death due to any cause (up to 5 years)
Number of Participants With Treatment-Emergent Adverse Events (AE) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.
Time frame: From Day 1 up to 28 days after last dose (maximum duration of 3 years)
Number of Participants With Treatment-Emergent Treatment Related Adverse Events and Serious Adverse Events (SAEs)
A treatment related AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event had a causal relationship with the treatment or usage. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness was judged by investigator. AEs included both serious and non-serious adverse events.
Time frame: From Day 1 up to 28 days after last dose (maximum duration of 3 years)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) By Severity
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AE was assessed according to severity as: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).
Time frame: From Day 1 up to 28 days after last dose (maximum duration of 3 years)
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology
Hematology parameters included anemia, hemoglobin increased, lymphocyte count increased, lymphocyte count decreased, neutrophil count decreased, platelet count decreased, and white blood cell count decreased. CTCAE grades: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).
Time frame: From Day 1 up to 28 days after last dose (maximum duration of 3 years)
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry
Chemistry parameters included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatine phosphokinase increased, creatinine increased, hypoalbuminemia, hypercalcemia, hypocalcemia, hyperglycemia, hypoglycemia, hyperkalemia, hypokalemia, hypernatremia, hyponatremia. CTCAE grades: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).
Time frame: From Day 1 up to 28 days after last dose (maximum duration of 3 years)
Number of Participants With Laboratory Abnormalities: Thyroid Function
Number of participants with thyrotropin levels: \<5 milli-international units per litre (mIU/L), \>=5 to \<10 mIU/L, \>=10 mIU/L are reported.
Time frame: From Day 1 up to 28 days after last dose (maximum duration of 3 years)
Number of Participants With Laboratory Abnormalities: Urinalysis
Number of participants with urine protein dipstick grading: negative/trace (5 to 20 milligram per deciliter \[mg/dL\]), 1+ (30 mg/dL\]), 2+ (100 mg/dL), 3+ (300 mg/dL) and 4+ (more than 1000 mg/dL) are reported.
Time frame: From Day 1 up to 28 days after last dose (maximum duration of 3 years)
A total of 128 study sites in 9 countries randomized 724 participants into this study.
| Milestone | Axitinib | Placebo |
|---|---|---|
| Started | 363 | 361 |
| Treated | 360 | 360 |
| Completed | 0 | 1 |
| Not completed | 363 | 360 |
| Withdrew: Anticancer therapy need not in protocol | 5 | 2 |
| Withdrew: Participant noncompliance | 4 | 4 |
| Withdrew: Lost to follow-up | 13 | 6 |
| Withdrew: Death | 31 | 33 |
| Withdrew: Adverse event | 3 | 2 |
| Withdrew: Investigator decision | 1 | 3 |
| Withdrew: Withdrawal by subject | 24 | 25 |
| Withdrew: Study terminated by sponsor | 282 | 285 |
DFS is defined as time interval from the date of randomization to first date of recurrence/relapse (distant or local recurrence of \[RCC\] or occurrence of a secondary malignancy {occurrence of a second primary cancer other than RCC} or death). For participants with no DFS event, DFS was censored at date of last scan prior to time of analyses. Participants alive who did not have post-baseline disease assessments, DFS was censored at randomization. Participants who received further anti-tumor therapy prior to recurrence or occurrence of a secondary malignancy or death, DFS was censored on date of last scan prior to taking anti-tumor medication. Participants who missed 2 or more consecutive tumor scans immediately followed by an event were censored at date of last objective tumor assessment prior to missing/not readable scan.
| years | Axitinib | Placebo |
|---|---|---|
| Disease Free Survival (DFS) as Assessed by Blinded Independent Review Committee (IRC) | NA (4.1 to NA) | NA (4.1 to NA) |
OS defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. Participants lacking data beyond randomization had their survival times censored at randomization.
| years | Axitinib | Placebo |
|---|---|---|
| Overall Survival (OS) | NA (NA to NA) | NA (NA to NA) |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.
| Participants | Axitinib | Placebo |
|---|---|---|
| AEs | 353 | 333 |
| SAEs | 75 | 54 |
A treatment related AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event had a causal relationship with the treatment or usage. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness was judged by investigator. AEs included both serious and non-serious adverse events.
| Participants | Axitinib | Placebo |
|---|---|---|
| Treatment Related AEs | 326 | 202 |
| Treatment Related SAEs | 27 | 9 |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AE was assessed according to severity as: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).
| Participants | Axitinib | Placebo |
|---|---|---|
| Grade 1 | 23 | 69 |
| Grade 2 | 108 | 152 |
| Grade 3 | 208 | 103 |
| Grade 4 | 12 | 8 |
| Grade 5 | 2 | 1 |
Hematology parameters included anemia, hemoglobin increased, lymphocyte count increased, lymphocyte count decreased, neutrophil count decreased, platelet count decreased, and white blood cell count decreased. CTCAE grades: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).
| Participants | Axitinib | Placebo |
|---|---|---|
| Anemia — Grade 1 | 256 | 233 |
| Anemia — Grade 2 | 87 | 114 |
| Anemia — Grade 3 | 8 | 6 |
| Anemia — Grade 4 | 0 | 2 |
| Anemia — Grade 5 | 0 | 0 |
| Hemoglobin increased — Grade 1 | 328 | 354 |
| Hemoglobin increased — Grade 2 | 23 | 1 |
| Hemoglobin increased — Grade 3 | 0 | 0 |
| Hemoglobin increased — Grade 4 | 0 | 0 |
| Hemoglobin increased — Grade 5 | 0 | 0 |
| Lymphocyte count decreased — Grade 1 | 305 | 282 |
| Lymphocyte count decreased — Grade 2 | 26 | 39 |
| Lymphocyte count decreased — Grade 3 | 19 | 33 |
| Lymphocyte count decreased — Grade 4 | 1 | 1 |
| Lymphocyte count decreased — Grade 5 | 0 | 0 |
| Lymphocyte count increased — Grade 1 | 343 | 339 |
| Lymphocyte count increased — Grade 2 | 0 | 0 |
| Lymphocyte count increased — Grade 3 | 8 | 16 |
| Lymphocyte count increased — Grade 4 | 0 | 0 |
| Lymphocyte count increased — Grade 5 | 0 | 0 |
| Neutrophil count decreased — Grade 1 | 284 | 299 |
| Neutrophil count decreased — Grade 2 | 48 | 45 |
| Neutrophil count decreased — Grade 3 | 19 | 8 |
| Neutrophil count decreased — Grade 4 | 0 | 3 |
| Neutrophil count decreased — Grade 5 | 0 | 0 |
| Platelet count decreased — Grade 1 | 267 | 303 |
| Platelet count decreased — Grade 2 | 77 | 49 |
| Platelet count decreased — Grade 3 | 5 | 1 |
| Platelet count decreased — Grade 4 | 0 | 1 |
| Platelet count decreased — Grade 5 | 0 | 0 |
| White blood cell count decreased — Grade 1 | 288 | 281 |
| White blood cell count decreased — Grade 2 | 55 | 67 |
| White blood cell count decreased — Grade 3 | 8 | 6 |
| White blood cell count decreased — Grade 4 | 0 | 1 |
| White blood cell count decreased — Grade 5 | 0 | 0 |
Chemistry parameters included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatine phosphokinase increased, creatinine increased, hypoalbuminemia, hypercalcemia, hypocalcemia, hyperglycemia, hypoglycemia, hyperkalemia, hypokalemia, hypernatremia, hyponatremia. CTCAE grades: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).
| Participants | Axitinib | Placebo |
|---|---|---|
| Alanine aminotransferase increased — Grade 1 | 1 | 2 |
| Alanine aminotransferase increased — Grade 2 | 0 | 3 |
| Alanine aminotransferase increased — Grade 3 | 0 | 0 |
| Alanine aminotransferase increased — Grade 4 | 1 | 1 |
| Alanine aminotransferase increased — Grade 5 | 0 | 0 |
| Alkaline phosphatase increased, — Grade 1 | 298 | 316 |
| Alkaline phosphatase increased, — Grade 2 | 53 | 37 |
| Alkaline phosphatase increased, — Grade 3 | 0 | 2 |
| Alkaline phosphatase increased, — Grade 4 | 0 | 0 |
| Alkaline phosphatase increased, — Grade 5 | 0 | 0 |
| Aspartate aminotransferase increased — Grade 1 | 0 | 1 |
| Aspartate aminotransferase increased — Grade 2 | 2 | 1 |
| Aspartate aminotransferase increased — Grade 3 | 1 | 3 |
| Aspartate aminotransferase increased — Grade 4 | 0 | 1 |
| Aspartate aminotransferase increased — Grade 5 | 0 | 0 |
| Blood bilirubin increased — Grade 1 | 315 | 330 |
| Blood bilirubin increased — Grade 2 | 30 | 18 |
| Blood bilirubin increased — Grade 3 | 6 | 6 |
| Blood bilirubin increased — Grade 4 | 0 | 1 |
| Blood bilirubin increased — Grade 5 | 0 | 0 |
| Creatine phosphokinase increased — Grade 1 | 0 | 0 |
| Creatine phosphokinase increased — Grade 2 | 0 | 0 |
| Creatine phosphokinase increased — Grade 3 | 0 | 0 |
| Creatine phosphokinase increased — Grade 4 | 2 | 1 |
| Creatine phosphokinase increased — Grade 5 | 0 | 1 |
| Creatinine increased — Grade 1 | 13 | 7 |
| Creatinine increased — Grade 2 | 274 | 301 |
| Creatinine increased — Grade 3 | 60 | 46 |
| Creatinine increased — Grade 4 | 3 | 0 |
| Creatinine increased — Grade 5 | 1 | 1 |
| Hypoalbuminemia — Grade 1 | 347 | 348 |
| Hypoalbuminemia — Grade 2 | 4 | 5 |
| Hypoalbuminemia — Grade 3 | 0 | 2 |
| Hypoalbuminemia — Grade 4 | 0 | 0 |
| Hypoalbuminemia — Grade 5 | 0 | 0 |
| Hypercalcemia — Grade 1 | 335 | 344 |
| Hypercalcemia — Grade 2 | 16 | 11 |
| Hypercalcemia — Grade 3 | 0 | 0 |
| Hypercalcemia — Grade 4 | 0 | 0 |
| Hypercalcemia — Grade 5 | 0 | 0 |
| Hypocalcemia — Grade 1 | 280 | 266 |
| Hypocalcemia — Grade 2 | 64 | 85 |
| Hypocalcemia — Grade 3 | 3 | 4 |
| Hypocalcemia — Grade 4 | 2 | 0 |
| Hypocalcemia — Grade 5 | 2 | 0 |
| Hyperglycemia — Grade 1 | 116 | 115 |
| Hyperglycemia — Grade 2 | 160 | 159 |
| Hyperglycemia — Grade 3 | 62 | 56 |
| Hyperglycemia — Grade 4 | 12 | 23 |
| Hyperglycemia — Grade 5 | 1 | 2 |
| Hypoglycemia — Grade 1 | 230 | 246 |
| Hypoglycemia — Grade 2 | 111 | 101 |
| Hypoglycemia — Grade 3 | 9 | 6 |
| Hypoglycemia — Grade 4 | 0 | 1 |
| Hypoglycemia — Grade 5 | 1 | 1 |
| Hyperkalemia — Grade 1 | 318 | 325 |
| Hyperkalemia — Grade 2 | 1 | 0 |
| Hyperkalemia — Grade 3 | 26 | 21 |
| Hyperkalemia — Grade 4 | 6 | 9 |
| Hyperkalemia — Grade 5 | 0 | 0 |
| Hypokalemia — Grade 1 | 340 | 348 |
| Hypokalemia — Grade 2 | 9 | 7 |
| Hypokalemia — Grade 3 | 0 | 0 |
| Hypokalemia — Grade 4 | 2 | 0 |
| Hypokalemia — Grade 5 | 0 | 0 |
| Hypernatremia — Grade 1 | 245 | 245 |
| Hypernatremia — Grade 2 | 96 | 94 |
| Hypernatremia — Grade 3 | 8 | 14 |
| Hypernatremia — Grade 4 | 2 | 2 |
| Hypernatremia — Grade 5 | 0 | 0 |
| Hyponatremia — Grade 1 | 331 | 338 |
| Hyponatremia — Grade 2 | 13 | 11 |
| Hyponatremia — Grade 3 | 0 | 0 |
| Hyponatremia — Grade 4 | 7 | 5 |
| Hyponatremia — Grade 5 | 0 | 1 |
Number of participants with thyrotropin levels: \<5 milli-international units per litre (mIU/L), \>=5 to \<10 mIU/L, \>=10 mIU/L are reported.
| Participants | Axitinib | Placebo |
|---|---|---|
| <5 mIU/L | 160 | 308 |
| >=5 - <10 mIU/L | 105 | 37 |
| >=10 mIU/L | 86 | 11 |
Number of participants with urine protein dipstick grading: negative/trace (5 to 20 milligram per deciliter \[mg/dL\]), 1+ (30 mg/dL\]), 2+ (100 mg/dL), 3+ (300 mg/dL) and 4+ (more than 1000 mg/dL) are reported.
| Participants | Axitinib | Placebo |
|---|---|---|
| Negative/trace | 135 | 237 |
| 1+ | 88 | 84 |
| 2+ | 74 | 24 |
| 3+ | 49 | 8 |
| 4+ | 5 | 2 |
Collected over From Day 1 up to 28 days after last dose (maximum duration of 3 years). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Axitinib | 31/360 (8.6%) | 75/360 (20.8%) | 353/360 (98.1%) |
| Placebo | 33/360 (9.2%) | 54/360 (15%) | 332/360 (92.2%) |
| Event | Axitinib | Placebo |
|---|---|---|
| CholecystitisHepatobiliary disorders | 5/360 | 1/360 |
| Acute Coronary SyndromeCardiac disorders | 3/360 | 0/360 |
| Acute Myocardial InfarctionCardiac disorders | 3/360 | 1/360 |
| Angina PectorisCardiac disorders | 2/360 | 0/360 |
| Cardiac Failure CongestiveCardiac disorders | 2/360 | 0/360 |
| Abdominal PainGastrointestinal disorders | 2/360 | 0/360 |
| DiarrhoeaGastrointestinal disorders | 2/360 | 0/360 |
| Large Intestine PolypGastrointestinal disorders | 0/360 | 2/360 |
| Pancreatitis AcuteGastrointestinal disorders | 2/360 | 0/360 |
| AppendicitisInfections and infestations | 2/360 | 1/360 |
| Event | Axitinib | Placebo |
|---|---|---|
| HypertensionVascular disorders | 231/360 | 91/360 |
| DiarrhoeaGastrointestinal disorders | 168/360 | 52/360 |
| DysphoniaRespiratory, thoracic and mediastinal disorders | 149/360 | 21/360 |
| Palmar-Plantar Ertythrodysaesthesia SyndromeSkin and subcutaneous tissue disorders | 115/360 | 17/360 |
| ProteniureaRenal and urinary disorders | 84/360 | 25/360 |
| FatigueGeneral disorders | 75/360 | 44/360 |
| HypothyroidismEndocrine disorders | 73/360 | 22/360 |
| NasopharyngitisInfections and infestations | 57/360 | 62/360 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 59/360 | 36/360 |
| Back PainMusculoskeletal and connective tissue disorders | 46/360 | 54/360 |
Intent-to-Treat (ITT) population included all randomized participants regardless of whether or not treatment was administered and based on randomized treatment assignment.
| Age, Categorical(Participants) | Axitinib | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 255 | 247 | 502 |
| >=65 years | 108 | 114 | 222 |
| Age, Continuous(Years) | Axitinib | Placebo | Total |
|---|---|---|---|
| Mean | 57.9 ± 10.80 | 58.1 ± 11.33 | 58.0 ± 11.06 |
| Sex: Female, Male(Participants) | Axitinib | Placebo | Total |
|---|---|---|---|
| Female | 83 | 111 | 194 |
| Male | 280 | 250 | 530 |
| Race (NIH/OMB)(Participants) | Axitinib | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 264 | 267 | 531 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 1 | 4 |
| White | 91 | 90 | 181 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 5 | 3 | 8 |
| Region of Enrollment(participants) | Axitinib | Placebo | Total |
|---|---|---|---|
| South Korea | 87 | 88 | 175 |
| Hong Kong | 6 | 5 | 11 |
| United States | 50 | 47 | 97 |
| Japan | 81 | 79 | 160 |
| China | 63 | 65 | 128 |
| Taiwan | 18 | 19 | 37 |
| France | 23 | 23 | 46 |
| India | 7 | 8 | 15 |
| Spain | 28 | 27 | 55 |
| BMI(Participants) | Axitinib | Placebo | Total |
|---|---|---|---|
| Normal Weight | 187 | 173 | 360 |
| Overweight + Obese | 165 | 175 | 340 |
| Overweight | 115 | 124 | 239 |
| Obese | 50 | 51 | 101 |
| Underweight | 7 | 12 | 19 |
| Missing | 4 | 1 | 5 |
Showing the first 100 of 106 sites across 9 countries.
Documents are hosted by the registry — open the source record to download them.
This study is terminated, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.