Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01765556
Other study ID # GO28054
Secondary ID 2012-003143-29
Status Withdrawn
Phase Phase 1
First received January 9, 2013
Last updated November 1, 2016
Start date October 2013
Est. completion date October 2013

Study information

Verified date November 2016
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This open-label, multi-center, three-period, one sequence study will investigate the effect of ketoconazole on the pharmacokinetics of vemurafenib in patients with unresectable BRAFV600-mutation positive metastatic melanoma or other malignant tumor type that harbors a V600-activating mutation of BRAF without acceptable standard treatment options. Patients will receive a single dose of vemurafenib in Periods A and C and multiple doses of ketoconazole in Periods B and C. Eligible patients will have the option to continue treatment with vemurafenib as part of an extension study (NCT01739764). The anticipated time on study treatment is approximately 19 days.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Male or female patients >= 18 years old

- Patients with either unresectable Stage IIIc or Stage IV metastatic melanoma positive for the BRAFV600 mutation or other malignant tumor type that harbors a V600-activating mutation of BRAF, as determined by results of cobasĀ® 4800 BRAF V600 mutation test or a DNA sequencing method, and who have no acceptable standard treatment options

- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

- Life expectancy >= 12 weeks

- Full recovery from the effects of any major surgery or significant traumatic injury within 14 days prior to the first dose of study treatment

- Adequate hematologic and end organ function

- Female patients of childbearing potential and male patients with partners of childbearing potential must agree to always use two effective methods of contraception

- Negative serum pregnancy test within 7 days prior to commencement of dosing in women of childbearing potential

Exclusion Criteria:

- Prior treatment with vemurafenib or other BRAF inhibitor within 42 days of first dose of study drug

- Requirement for immediate or urgent treatment with daily vemurafenib and for whom the intermittent schedule of vemurafenib employed during the 19-day period for this trial is not clinically acceptable

- Allergy or hypersensitivity to components of the vemurafenib formulation

- Experimental therapy within 4 weeks prior to first dose of study drug

- Major surgical procedure or significant traumatic injury within 14 days prior to first dose of study drug or anticipation of the need for major surgery during study treatment

- Prior anti-cancer therapy within 28 days before the first dose of study drug

- History of clinically significant cardiac or pulmonary dysfunction

- History of symptomatic congestive heart failure of any New York Heart Association class or serious cardiac arrhythmia requiring treatment

- History of myocardial infarction within 6 months prior to first dose of study drug

- Current dyspnea at rest, owing to complications of advanced malignancy or any requirement for supplemental oxygen to perform activities of daily living

- History of congenital long QT syndrome or QTc > 450 ms

- Active central nervous system lesions

- Uncontrolled or poorly controlled diabetes

- Current severe, uncontrolled systemic disease

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
ketoconazole
multiple doses of ketoconazole in Period B and C
vemurafenib
single dose of vemurafenib in Period A and C

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Outcome

Type Measure Description Time frame Safety issue
Primary Pharmacokinetics: Area under the concentration time curve Approximately 19 days No
Primary Pharmacokinetics: Maximum plasma concentration Approximately 19 days No
Primary Pharmacokinetics: Time to maximum plasma concentration Approximately 19 days No
Primary Pharmacokinetics: Terminal half-life Approximately 19 days No
Primary Pharmacokinetics: Apparent clearance Approximately 19 days No
Secondary Safety: Incidence of adverse events Approximately 19 days No
See also
  Status Clinical Trial Phase
Completed NCT01849666 - A Study of the Effect of Vemurafenib on the Pharmacokinetics of Phenprocoumon in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy Phase 1
Completed NCT01844674 - A Study on the Effect of Vemurafenib on the Pharmacokinetics of a Single Dose of Tizanidine in Patients With BRAFV600 Mutation-Positive Metastatic Malignancies Phase 1
Completed NCT01765569 - A Pharmacokinetics Study to Investigate the Effect of Vemurafenib on Digoxin in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma Phase 1
Completed NCT01765543 - A Pharmacokinetics Study to Investigate the Effect of Rifampin on Vemurafenib in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy Phase 1
Completed NCT01851824 - A Study of the Effect of Vemurafenib on the Pharmacokinetics of Acenocoumarol in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy Phase 1