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: January 6, 2014
Last verified: January 2014
  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:


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: December 2012
Primary Completion Date: December 2012 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: January 6, 2014
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 July 31, 2014