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NCT00608907 · REGISTRY CONDITION SEARCH

An Open-Label Study to Assess the Effect of CYP3A4 Induction on the Pharmacokinetics of VELCADE (Bortezomib)

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1
Status at capture
COMPLETED
Registry last update
2012-01-30

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Area Under the Plasma Concentration-time Curve (AUC) 0-72 Hours

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Control arm, bortezomib 1.3 mg/m\^2 on days 1, 4, 8, 11 over a 21-day treatment cycle.
    intervention Names
    1. Drug: bortezomib
    label
    VELCADE
    type
    EXPERIMENTAL
  2. description
    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.
    intervention Names
    1. Drug: bortezomib, rifampicin
    label
    VELCADE + rifampicin
    type
    EXPERIMENTAL
  3. description
    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.
    intervention Names
    1. Drug: bortezomib, dexamethasone
    label
    VELCADE + dexamethasone
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. VELCADE
    description
    1.3 mg/m\^3 on days 1, 4, 8, 11 over a 21-day treatment cycle
    name
    bortezomib
    other Names
    1. VELCADE
    type
    DRUG
  2. arm Group Labels
    1. VELCADE + rifampicin
    description
    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
    name
    bortezomib, rifampicin
    other Names
    1. bortezomib
    2. rifampicin
    type
    DRUG
  3. arm Group Labels
    1. VELCADE + dexamethasone
    description
    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
    name
    bortezomib, dexamethasone
    other Names
    1. bortezomib
    2. dexamethasone
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
61
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Area Under the Plasma Concentration-time Curve (AUC) 0-72 Hours
    time Frame
    Cycle 3 day 14 (72 hours post last dose)
Full 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.
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice