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A Phase I, Randomized, Open-label, Multi-center, Two Period Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of a Single Oral Dose of RO5185426, Followed by Administration of 960 mg RO5185426 Twice Daily to BRAF V600E Positive Metastatic Melanoma Patients


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Malignant Melanoma

Thank you

Trial Information

A Phase I, Randomized, Open-label, Multi-center, Two Period Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of a Single Oral Dose of RO5185426, Followed by Administration of 960 mg RO5185426 Twice Daily to BRAF V600E Positive Metastatic Melanoma Patients


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- Histologically confirmed metastatic melanoma (Stage IV, American Joint Committee on
Cancer)

- Positive BRAF V600E mutation result determined by Cobas 4800 BRAF V600 Mutation Test

- Previously treated patients must have failed at least one prior treatment regimen; if
patients have received prior systemic treatments for metastatic melanoma, the time
elapsed from previous therapy must be >/= 28 days; patients must have recovered fully
from toxicities of all prior therapy

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Evaluable disease (measurable for disease progression according to RECIST criteria)

- Adequate hematological, renal and liver function

Exclusion Criteria:

- Active CNS lesions

- History of or known spinal cord compression or carcinomatous meningitis

- Anticipated or ongoing administration of anti-cancer therapies other than those
administered in this study

- Previous malignancy within the past 5 years except for basal or squamous cell
carcinoma of the skin, melanoma in-situ and carcinoma in-situ of the cervix

- Previous treatment with BRAF inhibitor (sorafenib allowed) or MEK inhibitor

- Refractory nausea or vomiting, malabsorption, external biliary shunt, or history of
any type of gastrointestinal surgery that would preclude adequate absorption of study
drug

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Effect of food (high fat meal) on the pharmacokinetics of vemurafenib: AUC, C max, C min, T max, t1/2, k el

Outcome Time Frame:

21 days

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

NP25396

NCT ID:

NCT01264380

Start Date:

January 2011

Completion Date:

September 2013

Related Keywords:

  • Malignant Melanoma
  • Melanoma

Name

Location

Bettendorf, Iowa  52722
Fountain Valley, California  92708
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Denver, Colorado  
Baltimore, Maryland  21287
Indianapolis, Indiana  
Charleston, South Carolina  
Lebanon, New Hampshire