Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Stage IV Melanoma

Stopped early · Phase 2

Conditions studied: Acral Lentiginous Malignant Melanoma, Lentigo Maligna Malignant Melanoma, Nodular Malignant Melanoma, Recurrent Melanoma, Solar Radiation-related Skin Melanoma, Stage IV Melanoma, Superficial Spreading Malignant Melanoma

In brief

This phase II trial is studying how well gamma-secretase/Notch signalling pathway inhibitor RO4929097 works in treating patients with stage IV melanoma. Gamma-secretase/Notch signalling pathway inhibitor RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID: NCT01120275
Run by: National Cancer Institute (NCI)
People needed: 36
Starts: 2010-10-01
Expected to finish: 2015-08-01
Last updated by the study team: 2016-06-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have histologically confirmed melanoma of cutaneous or unknown origin (ocular primary and mucosal primary excluded); patients must have Stage IV disease
All patients must undergo a computed tomography (CT) or magnetic resonance imaging (MRI) of the brain within 42 days prior to registration that is negative for brain metastases; patients with a history of brain metastases are ineligible
Patients must have measurable disease; all measurable lesions must be assessed (by physical examination, CT, or MRI scan) within 28 days prior to registration; tests to assess non-measurable disease must be performed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation Criteria In Solid Tumors [RECIST] 1.1); the CT from a combined positron emission tomography (PET)/CT must not be used to document measurable disease unless it is of diagnostic quality
Sites must offer all patients participation in translational medicine studies and banking of paraffin embedded tissue and whole blood
Patients must not have received any prior systemic therapy for Stage IV disease except for noncytotoxic biologic agents (e.g., vaccines, cytokines, cell therapies that do not require cytotoxic agents); patients may have received prior treatment with up to two prior biological therapies - no cytotoxics or kinase inhibitors - for advanced disease
Patients may have had prior adjuvant immunotherapy with biological response modifiers (examples include but are not limited to interferon, vaccines, GM-CSF, and CTLA-4 blocking antibodies); prior adjuvant immunotherapy must have been completed at least 28 days prior to registration
Adjuvant therapy containing cytotoxic agents is allowed if completed >= 180 days prior to registration
Patients may have received prior radiation therapy; any side effects the patients had due to prior radiation therapy must have resolved to =< Grade 1 prior to registration; prior radiation therapy must have completed at least 28 days prior to registration
Patients must have Zubrod performance status of 0-1
Leukocytes >= 3,000/mcL
Absolute neutrophil count (ANC) >= 1,500/mcL
Platelets >= 100,000/mcL
Hemoglobin >= 9 g/dL
Total bilirubin =< institutional upper limit of normal (IULN)
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 x IULN
Serum creatinine =< IULN OR measured or calculated creatinine clearance >= 60 mL/min
Patients must have the following serum electrolytes within the institutional ranges of normal: potassium, sodium, magnesium, phosphorous, chloride and calcium (corrected for serum albumin); these tests must be performed within 28 days prior to registration; patient must not require parenteral replacement therapy
Patients must not have a history of allergic reaction attributed to compounds of similar chemical or biologic composition to RO4929097
Patients must be able to swallow tablets
Patients must not have malabsorption syndrome or other condition that would interfere with intestinal absorption of the agent
Patients taking medications with narrow therapeutic indices that are metabolized by cytochrome P450 (CYP450), including warfarin sodium (Coumadin), are ineligible
Patients must not be taking strong inducers or strong inhibitors of CYP3A4 at the time of registration
Patients must not be known to be serologically positive for Hepatitis A, B, or C, or have a history of liver disease, other forms of hepatitis, or cirrhosis
Patients must have an ECG within 28 days prior to registration. Patients must not have a QTcF > 450 msec (males) or QTcF > 470 msec (females)
Patients must not have symptomatic congestive heart failure or unstable angina pectoris

Where it is running

Fairbanks Memorial Hospital — Fairbanks, Alaska, United States
University of Arizona Health Sciences Center — Tucson, Arizona, United States
Saint Edward Mercy Medical Center — Fort Smith, Arkansas, United States
University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
Loma Linda University Medical Center — Loma Linda, California, United States
Fremont - Rideout Cancer Center — Marysville, California, United States
University of California Medical Center At Irvine-Orange Campus — Orange, California, United States
University of California at Davis Cancer Center — Sacramento, California, United States
Tahoe Forest Cancer Center — Truckee, California, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion — Aurora, Colorado, United States
Denver Veterans Administration Medical Center — Denver, Colorado, United States
Poudre Valley Hospital — Fort Collins, Colorado, United States
Saint Mary's Hospital and Regional Medical Center — Grand Junction, Colorado, United States
Saint Francis Hospital and Medical Center — Hartford, Connecticut, United States
Northeast Georgia Medical Center — Gainesville, Georgia, United States
Oncare Hawaii Inc-POB II — Honolulu, Hawaii, United States
Queen's Medical Center — Honolulu, Hawaii, United States
Straub Clinic and Hospital — Honolulu, Hawaii, United States
University of Hawaii — Honolulu, Hawaii, United States
Oncare Hawaii Inc-Kuakini — Honolulu, Hawaii, United States
The Cancer Center of Hawaii-Liliha — Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children — Honolulu, Hawaii, United States
Castle Medical Center — Kailua, Hawaii, United States
Wilcox Memorial Hospital and Kauai Medical Clinic — Lihue, Hawaii, United States
Providence Hospital — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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