An Open-Label Study to Assess the Effect of CYP3A4 Induction on the Pharmacokinetics of VELCADE (Bortezomib)
Study Details
Study Description
Brief Summary
The primary purpose of this Phase I study is to evaluate the effect of the co-administration of CYP3A4 inducers on the pharmacokinetics profile of VELCADE (bortezomib). Rifampicin will be used to assess the effect of a strong CYP3A4 inducer and dexamethasone to assess the effect of a relatively weak inducer. This study is also to evaluate the impact of CYP3A4 inducers on the pharmacodynamics (PD) of VELCADE and the safety profile of VELCADE.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: VELCADE Control arm, bortezomib 1.3 mg/m^2 on days 1, 4, 8, 11 over a 21-day treatment cycle. |
Drug: bortezomib
1.3 mg/m^3 on days 1, 4, 8, 11 over a 21-day treatment cycle
Other Names:
|
| Experimental: VELCADE + rifampicin Treatment Arm, bortezomib 1.3 mg/m^2 on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg once daily days 4 to 10 in cycle 3. |
Drug: bortezomib, rifampicin
bortezomib 1.3 mg/m^2 on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg once daily days 4 to 10 in cycle 3
Other Names:
|
| Experimental: VELCADE + dexamethasone Treatment arm, bortezomib 1.3 mg/m^2 on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg once daily days 1 to 4, and 9 to 12 in cycle 3. |
Drug: bortezomib, dexamethasone
bortezomib 1.3 mg/m^2 on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg once daily days 1 to 4, and 9 to 12 in cycle 3
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Area Under the Plasma Concentration-time Curve (AUC) 0-72 Hours [Cycle 3 day 14 (72 hours post last dose)]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female of at least 18 years of age.
-
Has documented relapsed or refractory multiple myeloma or NHL following prior anti-neoplastic treatment.
-
Female patients must be post menopausal for at least 1 year (must not have had a natural menses for at least 12 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; have a negative serum β-HCG or a negative urine pregnancy test at screening. (an alternative to oral contraceptives should be used if the patient is randomized to Arm B with rifampicin).
-
Male patients must agree to use an acceptable method of contraception (for themselves or female partners as listed above) for the duration of the study.
-
Must be able to swallow capsules/tablets whole (without chewing, crushing, or opening).
-
Agree to refrain from the use of any methylxanthine-containing products, including caffeine (e.g., chocolate bars or beverages, coffee, teas, or colas), on Day 11 of Cycles 2 and 3.
-
Agree to refrain from the use of any products containing nicotine, alcohol, quinine, grapefruit juice, or Seville oranges from 7 days before the first administration of VELCADE through completion of the 72-hour PK blood sample collection (post Day 11 VELCADE dose) in Cycle 3.
Exclusion Criteria:
-
Diagnosis or treatment of a malignancy other than multiple myeloma or NHL within 1 year of randomization, or who have previously been diagnosed with a malignancy other than multiple myeloma or NHL and have any radiographic or biochemical marker evidence of malignancy.
-
History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric, or metabolic disturbances.
-
Known or suspected hypersensitivity or intolerance to rifampicin and/or other antibiotics, corticosteroids, boron or mannitol.
-
Peripheral neuropathy or neuropathic pain Grade 2 or higher.
-
Preplanned surgery or procedures that would interfere with the conduct of the study or major surgery within 2 weeks before randomization.
-
History of disallowed therapies:
-
Prior treatment with VELCADE.
-
Any drugs or agents that inhibit (e.g., cimetidine, erythromycin, fluoxetine, ketoconazole, paroxetine) or induce (e.g., carbamazepine, glucocorticoids, phenobarbital, phenytoin, St. John's Wort) CYP2C19 or CYP3A4 within 28 days before the first administration of VELCADE.
-
Any exposure to rifampicin or corticosteroids within 28 days of screening.
-
Have received an investigational agent or used an investigational medical device within 28 days before the planned start of treatment. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study.
-
Female patient who is pregnant or breastfeeding.
-
Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hematology Institute - Davidoff Center - Rabin Medical Center | Petach Tikva | Israel | 49100 | |
| 2 | Divisione di Ematologia - Ospedale S Eugenio - P. le dell'Umanesimo | Rome | Italy | 10001 | |
| 3 | Medical Academy - Dept of Hematology and Transplantology | Gdansk | Poland | 80-952 | |
| 4 | Klinika Nowotworow Ukladu - Chlonnego - Centrum Onkologii - Instytut | Warszawa | Poland | 02-781 | |
| 5 | Hematological Oncology | Parow | Cape Town | South Africa | |
| 6 | Department of Hematology - University of the Free State | Bloemfontein | South Africa | 9300 | |
| 7 | Department of Medical Oncology - Ward 51 - Pretoria Academic Hospital | Pretoria | South Africa | 0001 | |
| 8 | Plymouth Hospitals NHS Trust - Derriford Hospital | Derriford | Plymouth | United Kingdom | PL68DH |
| 9 | Hematology Department Combined Laboratories - Derriford Hospital | Plymouth | United Kingdom | PL6 8DH |
Sponsors and Collaborators
- Millennium Pharmaceuticals, Inc.
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
- Study Director: Medical Monitor, Millennium Pharmaceuticals, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 26866138-CAN-1006
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | VELCADE | VELCADE + Rifampicin | VELCADE + Dexamethasone |
|---|---|---|---|
| Arm/Group Description | Control arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle. | Treatment Arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3. | Treatment arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3. |
| Period Title: Overall Study | |||
| STARTED | 30 | 13 | 18 |
| COMPLETED | 18 | 13 | 17 |
| NOT COMPLETED | 12 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | VELCADE | VELCADE + Rifampicin | VELCADE + Dexamethasone | Total |
|---|---|---|---|---|
| Arm/Group Description | Control arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle. | Treatment Arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3. | Treatment arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3. | Total of all reporting groups |
| Overall Participants | 30 | 13 | 18 | 61 |
| Age (Count of Participants) | ||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
14
46.7%
|
8
61.5%
|
8
44.4%
|
30
49.2%
|
| >=65 years |
16
53.3%
|
5
38.5%
|
10
55.6%
|
31
50.8%
|
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
64.7
(10.86)
|
60.2
(9.97)
|
62.3
(11.72)
|
63.0
(10.91)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
15
50%
|
7
53.8%
|
9
50%
|
31
50.8%
|
| Male |
15
50%
|
6
46.2%
|
9
50%
|
30
49.2%
|
Outcome Measures
| Title | Area Under the Plasma Concentration-time Curve (AUC) 0-72 Hours |
|---|---|
| Description | |
| Time Frame | Cycle 3 day 14 (72 hours post last dose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic (PK) evaluable population, include all subjects completed 3 cycles of treatment and all PK assessments during the first 3 cycles of the study. |
| Arm/Group Title | VELCADE + Rifampicin | VELCADE + Dexamethasone | VELCADE |
|---|---|---|---|
| Arm/Group Description | Treatment Arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3. | Treatment arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3. | Control arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle. |
| Measure Participants | 6 | 7 | 12 |
| Mean (Standard Deviation) [ng*h/mL] |
123
(34.2)
|
170
(64.5)
|
215
(58.4)
|
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | VELCADE | VELCADE + Rifampicin | VELCADE + Dexamethasone | |||
| Arm/Group Description | Control arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle. | Treatment Arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3. | Treatment arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3. | |||
All Cause Mortality |
||||||
| VELCADE | VELCADE + Rifampicin | VELCADE + Dexamethasone | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| VELCADE | VELCADE + Rifampicin | VELCADE + Dexamethasone | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 14/30 (46.7%) | 5/13 (38.5%) | 7/18 (38.9%) | |||
| Blood and lymphatic system disorders | ||||||
| Febrile Neutropenia | 0/30 (0%) | 0/13 (0%) | 1/18 (5.6%) | |||
| Cardiac disorders | ||||||
| Cardiopulmonary Failure | 1/30 (3.3%) | 0/13 (0%) | 0/18 (0%) | |||
| Ventricular Tachycardia | 0/30 (0%) | 0/13 (0%) | 1/18 (5.6%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal Pain | 2/30 (6.7%) | 0/13 (0%) | 0/18 (0%) | |||
| Constipation | 0/30 (0%) | 0/13 (0%) | 1/18 (5.6%) | |||
| Diarrhoea | 1/30 (3.3%) | 1/13 (7.7%) | 2/18 (11.1%) | |||
| Intestinal Obstruction | 1/30 (3.3%) | 0/13 (0%) | 0/18 (0%) | |||
| Stomatitis | 1/30 (3.3%) | 0/13 (0%) | 0/18 (0%) | |||
| Upper Gastrointestinal Haemorrhage | 0/30 (0%) | 1/13 (7.7%) | 0/18 (0%) | |||
| General disorders | ||||||
| Asthenia | 1/30 (3.3%) | 0/13 (0%) | 0/18 (0%) | |||
| Catheter Site Haemorrhage | 0/30 (0%) | 0/13 (0%) | 1/18 (5.6%) | |||
| Death | 0/30 (0%) | 0/13 (0%) | 1/18 (5.6%) | |||
| Disease Progression | 1/30 (3.3%) | 0/13 (0%) | 0/18 (0%) | |||
| Fatigue | 0/30 (0%) | 1/13 (7.7%) | 0/18 (0%) | |||
| Malaise | 1/30 (3.3%) | 0/13 (0%) | 0/18 (0%) | |||
| Pyrexia | 1/30 (3.3%) | 1/13 (7.7%) | 0/18 (0%) | |||
| Thrombosis in Device | 0/30 (0%) | 0/13 (0%) | 1/18 (5.6%) | |||
| Infections and infestations | ||||||
| Bronchitis | 1/30 (3.3%) | 0/13 (0%) | 0/18 (0%) | |||
| Bronchopneumonia | 1/30 (3.3%) | 0/13 (0%) | 0/18 (0%) | |||
| Cellulitis | 0/30 (0%) | 1/13 (7.7%) | 0/18 (0%) | |||
| Device Related Infection | 0/30 (0%) | 1/13 (7.7%) | 1/18 (5.6%) | |||
| Escherichia Bacteraemia | 0/30 (0%) | 0/13 (0%) | 1/18 (5.6%) | |||
| Escherichia Urinary Tract Infection | 1/30 (3.3%) | 0/13 (0%) | 0/18 (0%) | |||
| Gastroenteritis | 1/30 (3.3%) | 0/13 (0%) | 0/18 (0%) | |||
| Infection | 1/30 (3.3%) | 0/13 (0%) | 0/18 (0%) | |||
| Lobar Pneumonia | 1/30 (3.3%) | 0/13 (0%) | 1/18 (5.6%) | |||
| Lower Respiratory Tract Infection | 1/30 (3.3%) | 0/13 (0%) | 0/18 (0%) | |||
| Meningitis Listeria | 1/30 (3.3%) | 0/13 (0%) | 0/18 (0%) | |||
| Pneumonia | 1/30 (3.3%) | 0/13 (0%) | 0/18 (0%) | |||
| Viral Infection | 1/30 (3.3%) | 0/13 (0%) | 0/18 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Femoral Neck Fracture | 0/30 (0%) | 0/13 (0%) | 1/18 (5.6%) | |||
| Spinal Compression Fracture | 1/30 (3.3%) | 0/13 (0%) | 0/18 (0%) | |||
| Wrist Fracture | 0/30 (0%) | 0/13 (0%) | 1/18 (5.6%) | |||
| Metabolism and nutrition disorders | ||||||
| Dehydration | 0/30 (0%) | 1/13 (7.7%) | 1/18 (5.6%) | |||
| Hypercalcaemia | 1/30 (3.3%) | 0/13 (0%) | 1/18 (5.6%) | |||
| Tumour Lysis Syndrome | 1/30 (3.3%) | 0/13 (0%) | 0/18 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Musculoskeletal Chest Pain | 1/30 (3.3%) | 0/13 (0%) | 0/18 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Thyroid Cancer | 0/30 (0%) | 0/13 (0%) | 1/18 (5.6%) | |||
| Nervous system disorders | ||||||
| Paralysis | 1/30 (3.3%) | 0/13 (0%) | 0/18 (0%) | |||
| Syncope | 1/30 (3.3%) | 0/13 (0%) | 0/18 (0%) | |||
| Renal and urinary disorders | ||||||
| Renal Failure | 0/30 (0%) | 0/13 (0%) | 3/18 (16.7%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Asthma | 0/30 (0%) | 0/13 (0%) | 1/18 (5.6%) | |||
| Dyspnoea | 2/30 (6.7%) | 1/13 (7.7%) | 0/18 (0%) | |||
| Pulmonary Embolism | 1/30 (3.3%) | 0/13 (0%) | 0/18 (0%) | |||
| Vascular disorders | ||||||
| Circulatory Collapse | 0/30 (0%) | 1/13 (7.7%) | 0/18 (0%) | |||
| Hypotension | 0/30 (0%) | 1/13 (7.7%) | 1/18 (5.6%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| VELCADE | VELCADE + Rifampicin | VELCADE + Dexamethasone | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 28/30 (93.3%) | 13/13 (100%) | 18/18 (100%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 7/30 (23.3%) | 3/13 (23.1%) | 6/18 (33.3%) | |||
| Neutropenia | 7/30 (23.3%) | 6/13 (46.2%) | 10/18 (55.6%) | |||
| Thrombocytopenia | 8/30 (26.7%) | 5/13 (38.5%) | 8/18 (44.4%) | |||
| Eye disorders | ||||||
| Blepharitis | 1/30 (3.3%) | 0/13 (0%) | 2/18 (11.1%) | |||
| Conjunctivitis | 4/30 (13.3%) | 3/13 (23.1%) | 1/18 (5.6%) | |||
| Eye pain | 3/30 (10%) | 0/13 (0%) | 0/18 (0%) | |||
| Visual Acuity Reduced | 0/30 (0%) | 0/13 (0%) | 3/18 (16.7%) | |||
| Dry Eye | 1/30 (3.3%) | 1/13 (7.7%) | 4/18 (22.2%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal Distension | 4/30 (13.3%) | 0/13 (0%) | 2/18 (11.1%) | |||
| Dry mouth | 4/30 (13.3%) | 1/13 (7.7%) | 2/18 (11.1%) | |||
| Dyspepsia | 3/30 (10%) | 0/13 (0%) | 1/18 (5.6%) | |||
| Dysphagia | 2/30 (6.7%) | 1/13 (7.7%) | 0/18 (0%) | |||
| Epigastric discomfort | 1/30 (3.3%) | 1/13 (7.7%) | 1/18 (5.6%) | |||
| Gastritis | 1/30 (3.3%) | 1/13 (7.7%) | 2/18 (11.1%) | |||
| Vomiting | 8/30 (26.7%) | 6/13 (46.2%) | 3/18 (16.7%) | |||
| Nausea | 11/30 (36.7%) | 7/13 (53.8%) | 6/18 (33.3%) | |||
| General disorders | ||||||
| Chills | 4/30 (13.3%) | 2/13 (15.4%) | 1/18 (5.6%) | |||
| Oedema Peripheral | 8/30 (26.7%) | 1/13 (7.7%) | 2/18 (11.1%) | |||
| Hepatobiliary disorders | ||||||
| Hepatic Function Abnormal | 1/30 (3.3%) | 2/13 (15.4%) | 3/18 (16.7%) | |||
| Hyperbilirubinaemia | 1/30 (3.3%) | 0/13 (0%) | 2/18 (11.1%) | |||
| Infections and infestations | ||||||
| Herpes Zoster | 4/30 (13.3%) | 1/13 (7.7%) | 2/18 (11.1%) | |||
| Influenza | 1/30 (3.3%) | 0/13 (0%) | 2/18 (11.1%) | |||
| Nasopharyngitis | 3/30 (10%) | 2/13 (15.4%) | 0/18 (0%) | |||
| Oral Herpes | 1/30 (3.3%) | 0/13 (0%) | 2/18 (11.1%) | |||
| Sinusitis | 1/30 (3.3%) | 2/13 (15.4%) | 1/18 (5.6%) | |||
| Upper Respiratory Tract Infection | 7/30 (23.3%) | 2/13 (15.4%) | 7/18 (38.9%) | |||
| Injury, poisoning and procedural complications | ||||||
| Rib Fracture | 2/30 (6.7%) | 0/13 (0%) | 1/18 (5.6%) | |||
| Investigations | ||||||
| Weight Decreased | 2/30 (6.7%) | 1/13 (7.7%) | 0/18 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Decreased Appetite | 4/30 (13.3%) | 1/13 (7.7%) | 0/18 (0%) | |||
| Enzyme Abnormality | 1/30 (3.3%) | 1/13 (7.7%) | 2/18 (11.1%) | |||
| Hyperglycaemia | 2/30 (6.7%) | 1/13 (7.7%) | 0/18 (0%) | |||
| Hypertriglyceridaemia | 1/30 (3.3%) | 1/13 (7.7%) | 1/18 (5.6%) | |||
| Hyperuricaemia | 3/30 (10%) | 2/13 (15.4%) | 2/18 (11.1%) | |||
| Hypoalbuminaemia | 1/30 (3.3%) | 1/13 (7.7%) | 1/18 (5.6%) | |||
| Hypocalcaemia | 0/30 (0%) | 0/13 (0%) | 5/18 (27.8%) | |||
| Hypokalaemia | 3/30 (10%) | 2/13 (15.4%) | 2/18 (11.1%) | |||
| Hypomagnesaemia | 0/30 (0%) | 1/13 (7.7%) | 3/18 (16.7%) | |||
| Hyponatraemia | 3/30 (10%) | 0/13 (0%) | 0/18 (0%) | |||
| Hypophosphataemia | 2/30 (6.7%) | 0/13 (0%) | 3/18 (16.7%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 2/30 (6.7%) | 2/13 (15.4%) | 2/18 (11.1%) | |||
| Back Pain | 2/30 (6.7%) | 3/13 (23.1%) | 3/18 (16.7%) | |||
| Bone Pain | 4/30 (13.3%) | 3/13 (23.1%) | 5/18 (27.8%) | |||
| Muscle Spasms | 3/30 (10%) | 3/13 (23.1%) | 4/18 (22.2%) | |||
| Myalgia | 3/30 (10%) | 1/13 (7.7%) | 3/18 (16.7%) | |||
| Pain in Extremity | 6/30 (20%) | 5/13 (38.5%) | 4/18 (22.2%) | |||
| Nervous system disorders | ||||||
| Dizziness | 5/30 (16.7%) | 5/13 (38.5%) | 2/18 (11.1%) | |||
| Dysgeusia | 1/30 (3.3%) | 1/13 (7.7%) | 1/18 (5.6%) | |||
| Headache | 11/30 (36.7%) | 3/13 (23.1%) | 4/18 (22.2%) | |||
| Neuralgia | 3/30 (10%) | 3/13 (23.1%) | 6/18 (33.3%) | |||
| Neuropathy Peripheral | 1/30 (3.3%) | 0/13 (0%) | 2/18 (11.1%) | |||
| Paraesthesia | 1/30 (3.3%) | 2/13 (15.4%) | 3/18 (16.7%) | |||
| Peripheral Sensory Neuropathy | 7/30 (23.3%) | 6/13 (46.2%) | 10/18 (55.6%) | |||
| Psychiatric disorders | ||||||
| Dysthymic Disorder | 3/30 (10%) | 0/13 (0%) | 0/18 (0%) | |||
| Insomnia | 6/30 (20%) | 1/13 (7.7%) | 2/18 (11.1%) | |||
| Nightmare | 2/30 (6.7%) | 0/13 (0%) | 1/18 (5.6%) | |||
| Renal and urinary disorders | ||||||
| Renal Impairment | 3/30 (10%) | 2/13 (15.4%) | 2/18 (11.1%) | |||
| Reproductive system and breast disorders | ||||||
| Testicular Pain | 2/30 (6.7%) | 1/13 (7.7%) | 0/18 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 6/30 (20%) | 5/13 (38.5%) | 1/18 (5.6%) | |||
| Epistaxis | 2/30 (6.7%) | 2/13 (15.4%) | 1/18 (5.6%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Dry Skin | 1/30 (3.3%) | 1/13 (7.7%) | 1/18 (5.6%) | |||
| Rash | 5/30 (16.7%) | 2/13 (15.4%) | 4/18 (22.2%) | |||
| Rash Generalised | 1/30 (3.3%) | 1/13 (7.7%) | 2/18 (11.1%) | |||
| Vascular disorders | ||||||
| Hypertension | 1/30 (3.3%) | 1/13 (7.7%) | 3/18 (16.7%) | |||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Helgi van de Velde, MD, PhD |
|---|---|
| Organization | Johnson & Johnson Pharmaceutical Research & Development |
| Phone | |
| HVDVELDE@ITS.JNJ.COM |
- 26866138-CAN-1006