Brentuximab Vedotin in Chinese Participants With Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL)

Sponsor
Takeda (Industry)
Overall Status
Completed
CT.gov ID
NCT02939014
Collaborator
(none)
39
Enrollment
7
Locations
1
Arm
38.9
Actual Duration (Months)
5.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (PK) of brentuximab vedotin as a single agent in Chinese participants with relapsed/refractory CD30+ Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL).

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Brentuximab Vedotin
Phase 2

Detailed Description

The drug being tested in this study is called brentuximab vedotin. This study will look at efficacy, safety and PK of brentuximab vedotin in Chinese participants with relapsed/refractory CD30+ HL or sALCL.

The study will enroll approximately 30 patients. Participants will receive:

• Brentuximab vedotin 1.8 mg/kg

All participants will be administered IV infusion on Day 1 each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles.

This multi-center trial will be conducted in China only. The overall time to participate in this study is 3.5 years. Participants will make multiple visits to the clinic, and will be followed for overall survival (OS) every 12 weeks until death, withdrawal of consent, 18 months after end of treatment (EOT) or study closure, whichever occurs first.

Study Design

Study Type:
Interventional
Actual Enrollment :
39 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Single-Arm, Open-label Study of Brentuximab Vedotin in Chinese Patients With Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL)
Actual Study Start Date :
Nov 7, 2016
Actual Primary Completion Date :
Aug 2, 2018
Actual Study Completion Date :
Feb 3, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: Brentuximab Vedotin 1.8 mg/kg

Brentuximab vedotin 1.8 mg/kg, intravenous (IV) infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles.

Drug: Brentuximab Vedotin
Brentuximab vedotin IV infusion

Outcome Measures

Primary Outcome Measures

  1. Overall Response Rate (ORR) [Baseline, at Cycles (each cycle was of 3 weeks) 2, 4, 7, 10, 13, and 16 during treatment until disease progression death or end of treatment (approximately 12 months)]

    ORR is defined as the percentage of participants who have achieved complete remission (CR)=disappearance of all evidence of disease or partial remission (PR)=regression of greater than or equal to 50% of measurable disease and no new site by end of treatment (EOT) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

  2. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [First dose of study drug up to 30 days after last dose of study drug (approximately 12 months)]

    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs or worsens after receiving study drug.

  3. Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events [First dose of study drug up to 30 days after last dose of study drug (approximately 12 months)]

    Clinical Laboratory tests included tests of Chemistry, Hematology and Urinalysis prespecified in the protocol. Abnormal laboratory values assessed by the investigator that lead to discontinuation or delay in treatment, dose modification, therapeutic intervention, or were considered by the investigator to be clinically significant changes from Baseline were recorded as Adverse Events. Neutropenia (pooled) includes preferred terms Neutropenia and Neutrophil count decreased.

  4. Number of Participants With Abnormal Vital Signs Reported as Adverse Events [First dose of study drug up to 30 days after last dose of study drug (approximately 12 months)]

    Vital signs included blood pressure in the sitting position, pulse rate, axillary temperature and weight. Abnormal vital sign values considered by the investigator to be clinically significant were recorded as Adverse Events.

Secondary Outcome Measures

  1. Complete Remission (CR) Rate [Baseline, at Cycles (each cycle was of 3 weeks) 2, 4, 7, 10, 13, and 16 during treatment, and every 12 weeks during PFS follow-up period, until disease progression death or end of treatment (approximately 12 months)]

    CR rate is defined as the percentage of participants who have achieved CR by EOT. CR is defined as disappearance of all evidence of disease per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

  2. Duration of Response (DOR) [Up to 3.2 years]

    DOR is defined as the time between the first documentation of objective tumor response (CR or PR) and the first subsequent documentation of objective tumor progression or death due to any cause, whichever occurs first. CR is defined as disappearance of all evidence of disease. PR is defined as regression of greater than or equal to 50% of measurable disease and no new sites.

  3. Progression Free Survival (PFS) [Up to 3.2 years]

    PFS is defined as the time from the start of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.

  4. Overall Survival (OS) [Up to 3.2 years]

    Overall survival is defined as the time from the start of treatment to the date of death.

  5. B Symptom Resolution Rate [Day 1 of each cycle (each cycle was of 3 weeks) up to 30 days after last dose of study drug (approximately 12 months)]

    B Symptom Resolution Rate is defined as the percentage of participants with lymphoma-related symptoms (B symptoms: fever, night sweats, or weight loss >10%) at baseline who achieved resolution of all B symptoms at any time during the treatment period.

  6. Cmax: Maximum Observed Serum Concentration for Brentuximab Vedotin Antibody-drug Conjugate (ADC) [Cycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose]

  7. Cmax: Maximum Observed Serum Concentration for Total Antibody (TAb) [Cycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose]

  8. Cmax: Maximum Observed Plasma Concentration for Monomethyl Auristatin E (MMAE) [Cycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose]

  9. Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Brentuximab Vedotin ADC [Cycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose]

  10. Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAb [Cycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose]

  11. Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MMAE [Cycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose]

  12. AUC(0-∞): Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin ADC [Cycle (each cycle was of 3 weeks) 1: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose]

  13. AUC(0-∞): Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAb [Cycle (each cycle was of 3 weeks) 1: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose]

  14. AUC(0-∞): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MMAE [Cycle (each cycle was of 3 weeks) 1: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose]

  15. Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing Antitherapeutic Antibodies (nATA) to Brentuximab Vedotin [Baseline, at Cycles (each cycle was of 3 weeks) 2, 4, 7, 10, 13, and 16 during treatment until disease progression, death or end of treatment (approximately 12 months)]

    Blood samples were collected to assess the immunogenicity of brentuximab vedotin (ATA development) using a laboratory test to determine ATA titers. Confirmed ATA-positive response was categorized as transient (defined as 1 or 2 post-baseline confirmed ATA-positive responses) and persistent (defined as more than 2 post-baseline confirmed ATA positive responses) and by nATA status. The number of participants in each baseline ATA and post-baseline ATA categories are reported.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Have histologically confirmed CD30+ hodgkin lymphoma (HL) or systemic anaplastic large cell lymphoma (sALCL). Immunohistochemistry or flow cytometry may be performed on either original diagnostic biopsy material or biopsy of relapsed disease, and pathology reports of CD30+ or their copies should be retained at the site.

  2. With CD30+ HL or sALCL who have relapsed from or are refractory to previous treatments.

  3. Fluorodeoxyglucose (FDG)- positron emission tomography (PET) positive and measurable disease of at least 1.5 cm in the longest diameter by computed tomography (CT), as assessed by the site.

  4. Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

  5. Suitable venous access for the study-required blood sampling, including pharmacokinetic (PK) sampling.

  6. Must have the following required screening laboratory data. Participants must not have received recombinant granulocyte-colony stimulating factor (G-CSF) or platelet transfusion within 1 week before the screening hematology assessment.

  7. Absolute neutrophil count ≥1500/μL.

  8. Platelet count ≥75,000/μL.

  9. Serum bilirubin level ≤1.5 times the upper limit of the normal range (ULN).

  10. Serum creatinine level ≤1.5 times the ULN.

  11. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the ULN.

  12. Survival for 3 or more months must be expected.

Exclusion Criteria:
  1. With current diagnosis of primary cutaneous anaplastic large cell lymphoma (ALCL) (participants with other organ involvement who have transformed to sALCL are eligible).

  2. With any active viral, bacterial, or fungal infection within 2 weeks before the first dose of brentuximab vedotin.

  3. With cardiac failure categorized as Class III or IV according to the New York Heart Association criteria, uncontrolled coronary artery disease or uncontrolled arrhythmia despite of appropriate medical therapy, or a history of myocardial infarction within 6 months before the first dose of brentuximab vedotin.

  4. With uncontrolled diabetes mellitus.

  5. Peripheral neuropathy ≥Grade 2.

  6. With a history of another malignancy that has not been in remission for at least 3 years. The following are exempt from the 3-year limit:

  7. Nonmelanoma skin cancer.

  8. Curatively treated localized prostate cancer.

  9. Cervical carcinoma in situ.

  10. With known cerebral/meningeal disease (HL or any other etiology), including signs or symptoms of progressive multifocal leukoencephalopathy (PML).

  11. With a positive result in the screening test for human immunodeficiency virus (HIV) antibody.

  12. Known hepatitis B virus (HBV) surface antigen seropositive or positive hepatitis C virus (HCV) antibody. Note: participants who have positive HBV core antibody can be enrolled but must have an undetectable HBV viral load.

  13. With a history of liver fibrosis or cirrhosis and clinical signs and symptoms indicating liver fibrosis or cirrhosis.

  14. Have received autologous stem cell transplantation (auto-SCT) within 12 weeks before the first dose of brentuximab vedotin.

  15. With history of allogeneic stem cell transplantation (allo-SCT).

  16. Have received treatment for malignancies (including radiation, chemotherapy, and hormone therapy) within 4 weeks before the first dose of brentuximab vedotin and participants who have received treatment for malignancies with biologics (including molecular target drug) or radioisotopic therapy within 12 weeks before the first dose of brentuximab vedotin.

  17. Have unresolved toxicity higher than Grade 1 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.03) attributed to any prior therapy/procedure (excluding alopecia or non-clinically significant and asymptomatic laboratory abnormalities).

  18. Have received systemic corticosteroids at doses greater than the equivalent of 20 mg/day of prednisone within 1 week before the first dose of brentuximab vedotin.

  19. Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of the safety and toxicity of the prescribed regimens.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Beijing Cancer HospitalBeijingBeijingChina100142
2Peking University Third HospitalBeijingBeijingChina100191
3Sun Yat-san University Cancer CenterGuangzhouGuangdongChina510060
4Jiangsu Cancer HospitalNanjingJiangsuChina210009
5Jiangsu Province People's HospitalNanjingJiangsuChina210029
6The First Hospital of Jilin UniversityChangchunJilinChina
7Fudan University Shanghai Cancer CenterShanghaiShanghaiChina200010

Sponsors and Collaborators

  • Takeda

Investigators

  • Study Director: Medical Director Clinical Science, Takeda

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Takeda
ClinicalTrials.gov Identifier:
NCT02939014
Other Study ID Numbers:
  • C25010
  • U1111-1184-1838
First Posted:
Oct 19, 2016
Last Update Posted:
Feb 24, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Takeda
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment DetailsParticipants took part in the study at 7 investigative sites in China. The study was conducted from 07 November 2016 to 3 February 2020.
Pre-assignment DetailParticipants with a diagnosis of Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL) were enrolled to receive brentuximab vedotin 1.8 mg/kg, intravenous (IV) infusion, Day 1 of every 3-week cycle.
Arm/Group TitleBrentuximab Vedotin 1.8 mg/kg (HL)Brentuximab Vedotin 1.8 mg/kg (sALCL)
Arm/Group DescriptionBrentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
Period Title: Overall Study
STARTED309
COMPLETED256
NOT COMPLETED53

Baseline Characteristics

Arm/Group TitleBrentuximab Vedotin 1.8 mg/kg (HL)Brentuximab Vedotin 1.8 mg/kg (sALCL)Total
Arm/Group DescriptionBrentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).Total of all reporting groups
Overall Participants30939
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
31.9
(8.91)
41.1
(15.28)
34.0
(11.19)
Sex: Female, Male (Count of Participants)
Female
13
43.3%
2
22.2%
15
38.5%
Male
17
56.7%
7
77.8%
24
61.5%
Race/Ethnicity, Customized (Count of Participants)
Not Hispanic or Latino
30
100%
9
100%
39
100%
Race/Ethnicity, Customized (Count of Participants)
Asian
30
100%
9
100%
39
100%
Region of Enrollment (Count of Participants)
China
30
100%
9
100%
39
100%

Outcome Measures

1. Primary Outcome
TitleOverall Response Rate (ORR)
DescriptionORR is defined as the percentage of participants who have achieved complete remission (CR)=disappearance of all evidence of disease or partial remission (PR)=regression of greater than or equal to 50% of measurable disease and no new site by end of treatment (EOT) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Time FrameBaseline, at Cycles (each cycle was of 3 weeks) 2, 4, 7, 10, 13, and 16 during treatment until disease progression death or end of treatment (approximately 12 months)

Outcome Measure Data

Analysis Population Description
Modified Intent-to-Treat (mITT) Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin.
Arm/Group TitleBrentuximab Vedotin 1.8 mg/kg (HL)Brentuximab Vedotin 1.8 mg/kg (sALCL)
Arm/Group DescriptionBrentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
Measure Participants309
Number (95% Confidence Interval) [percentage of participants]
70.0
233.3%
66.7
741.1%
2. Primary Outcome
TitleNumber of Participants With Treatment-Emergent Adverse Events (TEAEs)
DescriptionAn Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs or worsens after receiving study drug.
Time FrameFirst dose of study drug up to 30 days after last dose of study drug (approximately 12 months)

Outcome Measure Data

Analysis Population Description
Safety Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin.
Arm/Group TitleBrentuximab Vedotin 1.8 mg/kg (HL)Brentuximab Vedotin 1.8 mg/kg (sALCL)
Arm/Group DescriptionBrentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
Measure Participants309
Count of Participants [Participants]
30
100%
9
100%
3. Primary Outcome
TitleNumber of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events
DescriptionClinical Laboratory tests included tests of Chemistry, Hematology and Urinalysis prespecified in the protocol. Abnormal laboratory values assessed by the investigator that lead to discontinuation or delay in treatment, dose modification, therapeutic intervention, or were considered by the investigator to be clinically significant changes from Baseline were recorded as Adverse Events. Neutropenia (pooled) includes preferred terms Neutropenia and Neutrophil count decreased.
Time FrameFirst dose of study drug up to 30 days after last dose of study drug (approximately 12 months)

Outcome Measure Data

Analysis Population Description
Safety Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin.
Arm/Group TitleBrentuximab Vedotin 1.8 mg/kg (HL)Brentuximab Vedotin 1.8 mg/kg (sALCL)
Arm/Group DescriptionBrentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
Measure Participants309
Alanine aminotransferase increased
18
60%
6
66.7%
Aspartate aminotransferase increased
17
56.7%
6
66.7%
Gamma-glutamyltransferase increased
3
10%
4
44.4%
Blood bilirubin increased
0
0%
2
22.2%
Reticulocyte count decreased
9
30%
2
22.2%
Reticulocyte count increased
6
20%
1
11.1%
Haemoglobin decreased
1
3.3%
1
11.1%
Reticulocyte percentage increased
1
3.3%
0
0%
White blood cell count decreased
4
13.3%
3
33.3%
Lymphocyte count decreased
5
16.7%
0
0%
Lymphocyte percentage decreased
2
6.7%
0
0%
Lymphocyte count increased
0
0%
1
11.1%
Lymphocyte percentage increased
0
0%
1
11.1%
Monocyte count increased
0
0%
1
11.1%
Neutrophil count increased
0
0%
1
11.1%
Neutrophil percentage decreased
1
3.3%
0
0%
White blood cell count increased
0
0%
1
11.1%
Platelet count decreased
2
6.7%
2
22.2%
Blood uric acid increased
2
6.7%
1
11.1%
Blood glucose increased
1
3.3%
1
11.1%
Blood albumin decreased
0
0%
1
11.1%
Protein total decreased
0
0%
1
11.1%
Blood creatinine increased
1
3.3%
1
11.1%
Blood urea decreased
0
0%
1
11.1%
Blood urea increased
0
0%
1
11.1%
Blood lactate dehydrogenase increased
0
0%
2
22.2%
Blood alkaline phosphatase increased
0
0%
1
11.1%
Blood cholesterol increased
0
0%
1
11.1%
Blood calcium decreased
0
0%
1
11.1%
Blood calcium increased
0
0%
1
11.1%
Blood chloride decreased
0
0%
1
11.1%
Blood phosphorus decreased
0
0%
1
11.1%
Blood potassium decreased
0
0%
1
11.1%
Blood triglycerides increased
0
0%
1
11.1%
Glucose urine present
1
3.3%
0
0%
Leukopenia
15
50%
2
22.2%
Anaemia
12
40%
3
33.3%
Hyperuricaemia
4
13.3%
2
22.2%
Hypertriglyceridaemia
2
6.7%
2
22.2%
Hypokalaemia
3
10%
2
22.2%
Blood creatine phosphokinase increased
1
3.3%
1
11.1%
Total bile acids increased
0
0%
2
22.2%
Alpha hydroxybutyrate dehydrogenase increased
0
0%
1
11.1%
Blood magnesium decreased
0
0%
1
11.1%
High density lipoprotein decreased
0
0%
1
11.1%
Hypercalcaemia
0
0%
1
11.1%
Hyperglycaemia
1
3.3%
0
0%
Hypoalbuminaemia
0
0%
1
11.1%
Hypocalcaemia
0
0%
1
11.1%
Hyponatraemia
1
3.3%
0
0%
Lipoprotein (a) increased
0
0%
1
11.1%
Low density lipoprotein increased
0
0%
1
11.1%
Monocytosis
0
0%
1
11.1%
Red blood cell sedimentation rate increased
1
3.3%
0
0%
Thrombocytopenia
1
3.3%
0
0%
Neutropenia (Pooled)
19
63.3%
5
55.6%
4. Primary Outcome
TitleNumber of Participants With Abnormal Vital Signs Reported as Adverse Events
DescriptionVital signs included blood pressure in the sitting position, pulse rate, axillary temperature and weight. Abnormal vital sign values considered by the investigator to be clinically significant were recorded as Adverse Events.
Time FrameFirst dose of study drug up to 30 days after last dose of study drug (approximately 12 months)

Outcome Measure Data

Analysis Population Description
Safety Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin.
Arm/Group TitleBrentuximab Vedotin 1.8 mg/kg (HL)Brentuximab Vedotin 1.8 mg/kg (sALCL)
Arm/Group DescriptionBrentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
Measure Participants309
Weight increased
4
13.3%
2
22.2%
Weight decreased
1
3.3%
2
22.2%
5. Secondary Outcome
TitleComplete Remission (CR) Rate
DescriptionCR rate is defined as the percentage of participants who have achieved CR by EOT. CR is defined as disappearance of all evidence of disease per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Time FrameBaseline, at Cycles (each cycle was of 3 weeks) 2, 4, 7, 10, 13, and 16 during treatment, and every 12 weeks during PFS follow-up period, until disease progression death or end of treatment (approximately 12 months)

Outcome Measure Data

Analysis Population Description
mITT Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin.
Arm/Group TitleBrentuximab Vedotin 1.8 mg/kg (HL)Brentuximab Vedotin 1.8 mg/kg (sALCL)
Arm/Group DescriptionBrentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
Measure Participants309
Number (95% Confidence Interval) [percentage of participants]
20.0
66.7%
55.6
617.8%
6. Secondary Outcome
TitleDuration of Response (DOR)
DescriptionDOR is defined as the time between the first documentation of objective tumor response (CR or PR) and the first subsequent documentation of objective tumor progression or death due to any cause, whichever occurs first. CR is defined as disappearance of all evidence of disease. PR is defined as regression of greater than or equal to 50% of measurable disease and no new sites.
Time FrameUp to 3.2 years

Outcome Measure Data

Analysis Population Description
mITT Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin. Only responders were analyzed for this outcome measure.
Arm/Group TitleBrentuximab Vedotin 1.8 mg/kg (HL)Brentuximab Vedotin 1.8 mg/kg (sALCL)
Arm/Group DescriptionBrentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
Measure Participants216
Median (95% Confidence Interval) [months]
12.0
NA
7. Secondary Outcome
TitleProgression Free Survival (PFS)
DescriptionPFS is defined as the time from the start of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.
Time FrameUp to 3.2 years

Outcome Measure Data

Analysis Population Description
mITT Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin.
Arm/Group TitleBrentuximab Vedotin 1.8 mg/kg (HL)Brentuximab Vedotin 1.8 mg/kg (sALCL)
Arm/Group DescriptionBrentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
Measure Participants309
Median (95% Confidence Interval) [months]
13.5
23.2
8. Secondary Outcome
TitleOverall Survival (OS)
DescriptionOverall survival is defined as the time from the start of treatment to the date of death.
Time FrameUp to 3.2 years

Outcome Measure Data

Analysis Population Description
mITT Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin.
Arm/Group TitleBrentuximab Vedotin 1.8 mg/kg (HL)Brentuximab Vedotin 1.8 mg/kg (sALCL)
Arm/Group DescriptionBrentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
Measure Participants309
Median (95% Confidence Interval) [months]
NA
NA
9. Secondary Outcome
TitleB Symptom Resolution Rate
DescriptionB Symptom Resolution Rate is defined as the percentage of participants with lymphoma-related symptoms (B symptoms: fever, night sweats, or weight loss >10%) at baseline who achieved resolution of all B symptoms at any time during the treatment period.
Time FrameDay 1 of each cycle (each cycle was of 3 weeks) up to 30 days after last dose of study drug (approximately 12 months)

Outcome Measure Data

Analysis Population Description
Participants from the mITT Population, all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin, who had lymphoma-related B symptoms at baseline.
Arm/Group TitleBrentuximab Vedotin 1.8 mg/kg (HL)Brentuximab Vedotin 1.8 mg/kg (sALCL)
Arm/Group DescriptionBrentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
Measure Participants22
Number (95% Confidence Interval) [percentage of participants]
50.0
166.7%
100.00
1111.1%
10. Secondary Outcome
TitleCmax: Maximum Observed Serum Concentration for Brentuximab Vedotin Antibody-drug Conjugate (ADC)
Description
Time FrameCycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

Outcome Measure Data

Analysis Population Description
Pharmacokinetic (PK)-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist.
Arm/Group TitleBrentuximab Vedotin 1.8 mg/kg
Arm/Group DescriptionBrentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles includes all participants.
Measure Participants39
Cycle 1
36.9504
(9.90360)
Cycle 2
32.4341
(5.83197)
11. Secondary Outcome
TitleCmax: Maximum Observed Serum Concentration for Total Antibody (TAb)
Description
Time FrameCycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

Outcome Measure Data

Analysis Population Description
PK-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist.
Arm/Group TitleBrentuximab Vedotin 1.8 mg/kg
Arm/Group DescriptionBrentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles includes all participants.
Measure Participants39
Cycle 1
38.2293
(7.95483)
Cycle 2
39.9859
(12.43445)
12. Secondary Outcome
TitleCmax: Maximum Observed Plasma Concentration for Monomethyl Auristatin E (MMAE)
Description
Time FrameCycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

Outcome Measure Data

Analysis Population Description
PK-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist.
Arm/Group TitleBrentuximab Vedotin 1.8 mg/kg
Arm/Group DescriptionBrentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles includes all participants.
Measure Participants39
Cycle 1
5.1623
(3.69893)
Cycle 2
3.6218
(2.89331)
13. Secondary Outcome
TitleTmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Brentuximab Vedotin ADC
Description
Time FrameCycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

Outcome Measure Data

Analysis Population Description
PK-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist.
Arm/Group TitleBrentuximab Vedotin 1.8 mg/kg
Arm/Group DescriptionBrentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles includes all participants.
Measure Participants39
Cycle 1
0.0576
Cycle 2
0.0528
14. Secondary Outcome
TitleTmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAb
Description
Time FrameCycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

Outcome Measure Data

Analysis Population Description
PK-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist.
Arm/Group TitleBrentuximab Vedotin 1.8 mg/kg
Arm/Group DescriptionBrentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles includes all participants.
Measure Participants39
Cycle 1
0.0653
Cycle 2
0.0660
15. Secondary Outcome
TitleTmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MMAE
Description
Time FrameCycles (each cycle was of 3 weeks) 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

Outcome Measure Data

Analysis Population Description
PK-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist.
Arm/Group TitleBrentuximab Vedotin 1.8 mg/kg
Arm/Group DescriptionBrentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles includes all participants.
Measure Participants39
Cycle 1
2.0729
Cycle 2
2.9785
16. Secondary Outcome
TitleAUC(0-∞): Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin ADC
Description
Time FrameCycle (each cycle was of 3 weeks) 1: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

Outcome Measure Data

Analysis Population Description
Participants from the PK-evaluable Populations, participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist, with data available for analysis.
Arm/Group TitleBrentuximab Vedotin 1.8 mg/kg
Arm/Group DescriptionBrentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles includes all participants.
Measure Participants38
Mean (Standard Deviation) [day*ug/mL]
79.9951
(19.59116)
17. Secondary Outcome
TitleAUC(0-∞): Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAb
Description
Time FrameCycle (each cycle was of 3 weeks) 1: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

Outcome Measure Data

Analysis Population Description
PK-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist.
Arm/Group TitleBrentuximab Vedotin 1.8 mg/kg
Arm/Group DescriptionBrentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles includes all participants.
Measure Participants39
Mean (Standard Deviation) [day*ug/mL]
168.6618
(41.62840)
18. Secondary Outcome
TitleAUC(0-∞): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MMAE
Description
Time FrameCycle (each cycle was of 3 weeks) 1: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

Outcome Measure Data

Analysis Population Description
PK-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist.
Arm/Group TitleBrentuximab Vedotin 1.8 mg/kg
Arm/Group DescriptionBrentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles includes all participants.
Measure Participants39
Mean (Standard Deviation) [day*ug/mL]
36.8625
(22.79816)
19. Secondary Outcome
TitleNumber of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing Antitherapeutic Antibodies (nATA) to Brentuximab Vedotin
DescriptionBlood samples were collected to assess the immunogenicity of brentuximab vedotin (ATA development) using a laboratory test to determine ATA titers. Confirmed ATA-positive response was categorized as transient (defined as 1 or 2 post-baseline confirmed ATA-positive responses) and persistent (defined as more than 2 post-baseline confirmed ATA positive responses) and by nATA status. The number of participants in each baseline ATA and post-baseline ATA categories are reported.
Time FrameBaseline, at Cycles (each cycle was of 3 weeks) 2, 4, 7, 10, 13, and 16 during treatment until disease progression, death or end of treatment (approximately 12 months)

Outcome Measure Data

Analysis Population Description
Immunogenicity Population included participants who received at least 1 dose of brentuximab vedotin and had ATA status assessment at baseline, and at least 1 postbaseline sample. Number analyzed is the number of participants with data available.
Arm/Group TitleBrentuximab Vedotin 1.8 mg/kg (HL)Brentuximab Vedotin 1.8 mg/kg (sALCL)
Arm/Group DescriptionBrentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
Measure Participants309
Baseline ATA Negative
29
96.7%
9
100%
Baseline ATA Negative, ATA Negative
21
70%
8
88.9%
Baseline ATA Negative, Transiently ATA Positive
7
23.3%
1
11.1%
Baseline ATA Negative, Persistently ATA Positive
1
3.3%
0
0%
Baseline ATA Negative, nATA Negative
0
0%
0
0%
Baseline ATA Negative, nATA Positive
8
26.7%
1
11.1%
Baseline ATA Positive
1
3.3%
0
0%
Baseline ATA Positive, ATA Negative
0
0%
Baseline ATA Positive, Transiently ATA Positive
0
0%
Baseline ATA Positive, Persistently ATA Positive
1
3.3%
Baseline ATA Positive, nATA Negative
0
0%
Baseline ATA Positive, nATA Positive
1
3.3%

Adverse Events

Time FrameAll-Cause Mortality: up to 3.2 years; Serious and Other Adverse Events: First dose of study drug up to 30 days post last dose of study drug (up to 12 months)
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Arm/Group TitleBrentuximab Vedotin 1.8 mg/kg (HL)Brentuximab Vedotin 1.8 mg/kg (sALCL)
Arm/Group DescriptionBrentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL).Brentuximab vedotin 1.8 mg/kg, IV, infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles in participants with Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma (sALCL).
All Cause Mortality
Brentuximab Vedotin 1.8 mg/kg (HL)Brentuximab Vedotin 1.8 mg/kg (sALCL)
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total4/30 (13.3%) 3/9 (33.3%)
Serious Adverse Events
Brentuximab Vedotin 1.8 mg/kg (HL)Brentuximab Vedotin 1.8 mg/kg (sALCL)
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total1/30 (3.3%) 1/9 (11.1%)
Gastrointestinal disorders
Large intestine polyp0/30 (0%) 1/9 (11.1%)
Infections and infestations
Lung infection1/30 (3.3%) 0/9 (0%)
Other (Not Including Serious) Adverse Events
Brentuximab Vedotin 1.8 mg/kg (HL)Brentuximab Vedotin 1.8 mg/kg (sALCL)
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total30/30 (100%) 9/9 (100%)
Blood and lymphatic system disorders
Leukopenia15/30 (50%) 2/9 (22.2%)
Anaemia12/30 (40%) 3/9 (33.3%)
Neutropenia19/30 (63.3%) 5/9 (55.6%)
Monocytosis0/30 (0%) 1/9 (11.1%)
Lymphadenopathy0/30 (0%) 1/9 (11.1%)
Cardiac disorders
Palpitations2/30 (6.7%) 0/9 (0%)
Gastrointestinal disorders
Diarrhoea8/30 (26.7%) 3/9 (33.3%)
Nausea8/30 (26.7%) 0/9 (0%)
Vomiting4/30 (13.3%) 1/9 (11.1%)
Retching0/30 (0%) 1/9 (11.1%)
Abdominal distension4/30 (13.3%) 0/9 (0%)
Flatulence3/30 (10%) 0/9 (0%)
Dyspepsia4/30 (13.3%) 0/9 (0%)
Abdominal pain upper3/30 (10%) 0/9 (0%)
Gastrooesophageal reflux disease3/30 (10%) 0/9 (0%)
Abdominal discomfort1/30 (3.3%) 1/9 (11.1%)
Gingival bleeding0/30 (0%) 1/9 (11.1%)
General disorders
Malaise6/30 (20%) 1/9 (11.1%)
Asthenia4/30 (13.3%) 0/9 (0%)
Pyrexia6/30 (20%) 4/9 (44.4%)
Pain3/30 (10%) 0/9 (0%)
Chest discomfort1/30 (3.3%) 1/9 (11.1%)
Infections and infestations
Upper respiratory tract infection9/30 (30%) 2/9 (22.2%)
Nasopharyngitis1/30 (3.3%) 1/9 (11.1%)
Tonsillitis0/30 (0%) 1/9 (11.1%)
Herpes zoster2/30 (6.7%) 1/9 (11.1%)
Nail infection0/30 (0%) 1/9 (11.1%)
Gastroenteritis0/30 (0%) 1/9 (11.1%)
Investigations
Alanine aminotransferase increased18/30 (60%) 6/9 (66.7%)
Aspartate aminotransferase increased17/30 (56.7%) 6/9 (66.7%)
Gamma-glutamyltransferase increased3/30 (10%) 4/9 (44.4%)
Blood bilirubin increased0/30 (0%) 2/9 (22.2%)
Reticulocyte count decreased9/30 (30%) 2/9 (22.2%)
Reticulocyte count increased6/30 (20%) 1/9 (11.1%)
Haemoglobin decreased1/30 (3.3%) 1/9 (11.1%)
White blood cell count decreased4/30 (13.3%) 3/9 (33.3%)
Lymphocyte count decreased5/30 (16.7%) 0/9 (0%)
Lymphocyte percentage decreased2/30 (6.7%) 0/9 (0%)
Lymphocyte count increased0/30 (0%) 1/9 (11.1%)
Lymphocyte percentage increased0/30 (0%) 1/9 (11.1%)
Monocyte count increased0/30 (0%) 1/9 (11.1%)
Neutrophil count increased0/30 (0%) 1/9 (11.1%)
White blood cell count increased0/30 (0%) 1/9 (11.1%)
Weight increased4/30 (13.3%) 2/9 (22.2%)
Weight decreased1/30 (3.3%) 2/9 (22.2%)
Platelet count decreased2/30 (6.7%) 2/9 (22.2%)
Blood uric acid increased2/30 (6.7%) 1/9 (11.1%)
Retinol binding protein increased0/30 (0%) 1/9 (11.1%)
Blood glucose increased1/30 (3.3%) 1/9 (11.1%)
Blood albumin decreased0/30 (0%) 1/9 (11.1%)
Protein total decreased0/30 (0%) 1/9 (11.1%)
Blood creatinine increased1/30 (3.3%) 1/9 (11.1%)
Blood urea decreased0/30 (0%) 1/9 (11.1%)
Blood urea increased0/30 (0%) 1/9 (11.1%)
Blood creatine phosphokinase increased1/30 (3.3%) 1/9 (11.1%)
Alpha hydroxybutyrate dehydrogenase increased0/30 (0%) 1/9 (11.1%)
Blood lactate dehydrogenase increased0/30 (0%) 2/9 (22.2%)
Blood alkaline phosphatase increased0/30 (0%) 1/9 (11.1%)
Blood cholesterol increased0/30 (0%) 1/9 (11.1%)
High density lipoprotein decreased0/30 (0%) 1/9 (11.1%)
Lipoprotein (a) increased0/30 (0%) 1/9 (11.1%)
Low density lipoprotein increased0/30 (0%) 1/9 (11.1%)
Electrocardiogram abnormal0/30 (0%) 1/9 (11.1%)
Blood calcium decreased0/30 (0%) 1/9 (11.1%)
Blood calcium increased0/30 (0%) 1/9 (11.1%)
Blood chloride decreased0/30 (0%) 1/9 (11.1%)
Blood magnesium decreased0/30 (0%) 1/9 (11.1%)
Blood phosphorus decreased0/30 (0%) 1/9 (11.1%)
Blood potassium decreased0/30 (0%) 1/9 (11.1%)
Blood triglycerides increased0/30 (0%) 1/9 (11.1%)
Metabolism and nutrition disorders
Hyperuricaemia4/30 (13.3%) 2/9 (22.2%)
Hypertriglyceridaemia2/30 (6.7%) 2/9 (22.2%)
Hypokalaemia3/30 (10%) 0/9 (0%)
Hypercalcaemia0/30 (0%) 1/9 (11.1%)
Hypocalcaemia0/30 (0%) 1/9 (11.1%)
Hypoalbuminaemia0/30 (0%) 1/9 (11.1%)
Musculoskeletal and connective tissue disorders
Back pain1/30 (3.3%) 1/9 (11.1%)
Muscle spasms2/30 (6.7%) 0/9 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain0/30 (0%) 1/9 (11.1%)
Nervous system disorders
Peripheral sensory neuropathy9/30 (30%) 2/9 (22.2%)
Neuropathy peripheral0/30 (0%) 2/9 (22.2%)
Headache8/30 (26.7%) 0/9 (0%)
Hypoaesthesia4/30 (13.3%) 2/9 (22.2%)
Dizziness5/30 (16.7%) 1/9 (11.1%)
Psychiatric disorders
Insomnia2/30 (6.7%) 0/9 (0%)
Respiratory, thoracic and mediastinal disorders
Cough3/30 (10%) 2/9 (22.2%)
Interstitial lung disease1/30 (3.3%) 1/9 (11.1%)
Epistaxis1/30 (3.3%) 1/9 (11.1%)
Oropharyngeal pain1/30 (3.3%) 1/9 (11.1%)
Skin and subcutaneous tissue disorders
Alopecia8/30 (26.7%) 1/9 (11.1%)
Rash3/30 (10%) 2/9 (22.2%)
Night sweats3/30 (10%) 0/9 (0%)
Hyperhidrosis0/30 (0%) 1/9 (11.1%)
Dermatitis allergic2/30 (6.7%) 1/9 (11.1%)
Urticaria2/30 (6.7%) 1/9 (11.1%)
Pruritus2/30 (6.7%) 0/9 (0%)
Papule0/30 (0%) 1/9 (11.1%)
Psoriasis0/30 (0%) 1/9 (11.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application

Results Point of Contact

Name/TitleMedical Director
OrganizationTakeda
Phone+1-877-825-3327
Emailtrialdisclosures@takeda.com
Responsible Party:
Takeda
ClinicalTrials.gov Identifier:
NCT02939014
Other Study ID Numbers:
  • C25010
  • U1111-1184-1838
First Posted:
Oct 19, 2016
Last Update Posted:
Feb 24, 2021
Last Verified:
Feb 1, 2021