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A Pharmacokinetic and Metabolism Study of 14C-labeled RO5185426 on Patients With Metastatic Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01164891
First received: July 16, 2010
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This open-label, non-randomized study will assess the mass balance, metabolism, routes and rates of elimination as well as efficacy and safety of RO5185426 (RG7204; PLEXXIKON; PLX4032) in previously treated or untreated patients with metastatic melanoma. Patients will receive continuous twice daily oral treatment with RO5185426. On Day 15, a 14C-labeled dose will be administered. Anticipated time on study treatment is until disease progression occurs.


Condition Intervention Phase
Malignant Melanoma
 Drug: RO5185426
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Open-label, Excretion Balance, Pharmacokinetic and Metabolism Study After Single Oral Dose of 14C-labeled RO5185426 in Previously Treated and Untreated Patients With Metastatic Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pharmacokinetics: Mass balance, metabolism, routes and rates of elimination of 14C-labeled RO5185426 [ Time Frame: Day 14 to Day 36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability: Adverse events, laboratory parameters, ECG [ Time Frame: from baseline to disease progression, withdrawal from study or death of any cause ] [ Designated as safety issue: No ]
  • Efficacy: Best Overall Response Rate (ORR): tumor assessments by CT/MRI/bone scan, according to RECIST criteria [ Time Frame: from baseline to disease progression, withdrawal from study or death of any cause ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: from baseline to death of any cause ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: July 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: RO5185426
Continuous oral dosing b.i.d. , on Day 15 a C isotope labeled dose will be administered

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Histologically confirmed metastatic melanoma, surgically incurable and unresectable Stage IIIc or IV (AJCC)
  • Prior treatment for metastatic melanoma allowed; >/= 28 days must be elapsed since previous systemic treatment prior to first administration of study drug
  • Positive BRAF V600E mutation result (by Roche CoDx test)
  • ECOG performance status 0-1
  • Adequate hematologic, renal and liver function
  • Body Mass Index (BMI) 18 to 32 kg/m2 inclusive

Exclusion Criteria:

  • Active CNS lesions
  • History of or known spinal cord compression, or carcinomatous meningitis
  • Anticipated or ongoing administration of any anticancer therapies other than those administered in this study
  • Refractory nausea or vomiting, or other medical conditions that are capable of altering the absorption, metabolism or elimination of the study drug
  • Known clinically significant active infection
  • Known HIV positivity or AIDS-related illness, active HBV, or active HCV
  • 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
  • Clinically significant cardiovascular disease or incident within the 6 months prior to study drug administration
  • Patients who have had at least one dose of study drug (RO5185426 or comparator) in a clinical trial that includes RO5185426
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01164891

Locations
Switzerland
Zürich, Switzerland, 8091
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01164891     History of Changes
Other Study ID Numbers: NP25158
Study First Received: July 16, 2010
Last Updated: May 7, 2013
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on May 22, 2013