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A Study to Investigate the Effect of Itraconazole and Rifampin on Pharmacokinetics (PK) of Vemurafenib at Steady State

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ClinicalTrials.gov Identifier: NCT02608034
Recruitment Status : Completed
First Posted : November 18, 2015
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This is a two-part, Phase 1, open-label, multicenter, two-period, one-sequence study to investigate the effect of itraconazole and rifampin on the PK of vemurafenib following multiple 960 milligrams (mg) twice daily (BID) dosing in adult participants with unresectable Stage IIIC or Stage IV metastatic melanoma positive for the BRAF V600 mutation, or other malignant tumor types that harbor a V600-activating mutation of BRAF where the participant has no acceptable standard treatment options.

Condition or disease Intervention/treatment Phase
Metastatic Melanoma, BRAF V600 Mutation Positive Drug: Itraconazole Drug: Rifampin Drug: Vemurafenib Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Two-part, Phase I, Open-label, Multicenter, Two-period, One-sequence Study to Investigate the Effect of Itraconazole and Rifampin on the PK of Vemurafenib at Steady State
Actual Study Start Date : May 26, 2016
Actual Primary Completion Date : September 10, 2018
Actual Study Completion Date : September 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Part 1: Vemurafenib+Itraconazole
Part 1: Participants will receive vemurafenib orally BID up to Day 20 (Period A) followed by vemurafenib orally BID along with itraconazole orally once in the morning from Days 21 to 40 (Period B).\nPart 2: Participants will receive vemurafenib orally BID up to Day 20 (Period A) followed by vemurafenib orally BID along with rifampin orally once in the morning from Days 21 to 40 (Period B).
Drug: Itraconazole
Itraconazole will be administered as a 200 mg oral solution QD during Part 1 only for 20 consecutive days.

Drug: Rifampin
Rifampin will be administered as a 600 mg oral solution QD during Part 2 only for 20 consecutive days.

Drug: Vemurafenib
Vemurafenib will be administered in both Part 1 and Part 2 at a dose of 960 mg BID for at least 40 conseutive days.




Primary Outcome Measures :
  1. Area under the concentration-time curve From Time 0 to 12 Hours Postdose (AUC0-12) [ Time Frame: Period A and B: Pre-morning dose on Day 18, 19, and 20 and 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose on Day 20 ]
  2. Maximum observed concentration (Cmax) [ Time Frame: Period A and B: Pre-morning dose on Day 18, 19, and 20 and 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose on Day 20 ]
  3. Time to maximum concentration (Tmax) [ Time Frame: Period A and B: Pre-morning dose on Day 18, 19, and 20 and 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose on Day 20 ]

Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: 28 days after last dose of study treatment (last dose = Day 40) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with age greater than or equal to (>=) 18 years with either unresectable Stage IIIC or Stage IV metastatic melanoma positive for the BRAF V600 mutation, or other malignant tumor types that harbor a V600-activating mutation of BRAF
  • Eastern Cooperative Oncology Group Performance Status 0 to 2
  • Life expectancy >=12 weeks
  • Adequate hematologic and end organ function obtained within 2 weeks prior to first dose of study drug
  • Female participants of childbearing potential and male participants with partners of childbearing potential must agree to always use two effective methods of contraception including at least one method with a failure rate of <1% per year during the course of the study and for at least 6 months after completion of study treatment
  • Negative serum pregnancy test within 7 days prior to commencement of dosing in women of childbearing potential
  • Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Exclusion Criteria:

  • Prior treatment with vemurafenib or other BRAF inhibitor within 42 days of Study Day 1 of Period A
  • Allergy or hypersensitivity to components of the vemurafenib formulation
  • Experimental therapy within 4 weeks prior to first dose of study drug treatment on Study Day 1 of Period A
  • Major surgical procedure or significant traumatic injury within 14 days prior to first dose of study drug treatment on Study Day 1 of Period A, or anticipation of the need for major surgery during study treatment
  • Prior anti-cancer therapy (e.g., biologic or other targeted therapy, chemotherapy) within 28 days (6 weeks for nitrosoureas or mitomycin C, and 14 days for hormonal therapy or kinase inhibitors) before the first dose of study treatment on Study Day 1 of Period A.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608034


Locations
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United States, Kansas
University of Kansas Cancer Center and Medical Pavilion
Westwood, Kansas, United States, 66205
United States, Texas
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75230
Israel
Rambam Health Care Campus; Oncology
Haifa, Israel, 3109601
Hadassah Ein Karem Hospital; Oncology Dept
Jerusalem, Israel, 9112001
Tel Aviv Sourasky Medical Center; Pharmacy
Tel Aviv, Israel, 64239
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Samsung Medical Center; Gastroenterology
Seoul, Korea, Republic of, 135-710
Asan Medical Center; Division of Oncology
Seoul, Korea, Republic of, 138-736
Severance Hospital - Yonsei Uni ; Obstetrics & Gynaecology Dept.
Seoul, Korea, Republic of
Russian Federation
Republican Clinical Oncologic Dispensary of Republic Of Tatarstan
Kazan, Russian Federation, 420029
FSBSI "N. N. Blokhin Russian Cancer Research Center"
Moscow, Russian Federation, 115478
St. Petersburg Oncology Hospital
St Petersburg, Russian Federation, 198255
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02608034     History of Changes
Other Study ID Numbers: GO29475
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Itraconazole
Hydroxyitraconazole
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Rifampin
Vemurafenib
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers