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A SINGLE ARM, OPEN LABEL, EXPANDED ACCESS STUDY OF RG7204 IN PREVIOUSLY TREATED PATIENTS WITH METASTATIC MELANOMA


Phase 2
18 Years
N/A
Not Enrolling
Both
Malignant Melanoma

Thank you

Trial Information

A SINGLE ARM, OPEN LABEL, EXPANDED ACCESS STUDY OF RG7204 IN PREVIOUSLY TREATED PATIENTS WITH METASTATIC MELANOMA


Inclusion Criteria:



- Histologically confirmed metastatic melanoma with documented BRAF V600E mutation,
determined by the cobas BRAF V600 mutation test

- Patients with clinical evidence of disease progression during or after at least one
prior systemic therapy for metastatic melanoma

- Patients with either measurable or non-measurable disease

- Adequate recovery from most recent systemic or local treatment for metastatic
melanoma

- Adequate organ funcion

- For women of childbearing potential, agreement to the use of two acceptable methods
of contraception, including one barrier method, during the study and for 6 months
after discontinuation of RO5185426

- For men with female partners of childbearing potential, agreement to use a latex
condom, and to advise their female partner to use an additional method of
contraception during the study and for 6 months after discontinuation of RO5185426

- Negative serum or urine pregnancy test within 7 days of commencement of treatment in
premenopausal women. Women who are either surgically sterile or have been
post-menopausal for at least 1 year are eligible to participate in this study

- Agreement not to donate blood or blood products during the study and for at least 6
months after disconinuation of RO5185426; for male patients, agreement not to donate
sperm during the study and for at least 6 months after discontinuation of RO5185426

Exclusion Criteria:

- Evidence of symptomatic CNS lesions as determined by investigator

- Patients with a previous malignancy within the past 2 years are excluded except for
patients with basal or squamous cell carcinoma (SCC) of the skin or carcinoma in-situ
of the cervix. Isolated elevation in PSA in absence of radiographic evidence of
metastatic prostate cancer is allowed

- Pregnant or breast-feeding

- Concurrent anti-tumor therapy

- Any of the following within 6 months prior to study drug administration: myocardial
infarction, severe/unstable angina, symptomatic congestive heart failure,
cerebrovascular accident or transient ischemic attack, pulmonary embolism,
hypertension not adequately controlled by current medications

- Uncontrolled medical illness

Type of Study:

Expanded Access

Study Design:

N/A

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

ML25597

NCT ID:

NCT01248936

Start Date:

December 2010

Completion Date:

Related Keywords:

  • Malignant Melanoma
  • Melanoma

Name

Location

Hinsdale, Illinois  60521
New Britain, Connecticut  06052
Albany, Georgia  31701
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
McLean, Virginia  22101
Denver, Colorado  
Boston, Massachusetts  
Eugene, Oregon  
Charleston, South Carolina  
Tulsa, Oklahoma