Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Participants With Previously Treated Solid Tumors



Status:Recruiting
Conditions:Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 30
Updated:3/6/2019
Start Date:May 20, 2016
End Date:February 21, 2023
Contact:Reference Study ID Number: GO29665 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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A Phase I/II, Multicenter, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Cobimetinib In Pediatric and Young Adult Patients With Previously Treated Solid Tumors

This open-label, dose-escalation study is designed to evaluate the safety, tolerability,
pharmacokinetics, and preliminary efficacy of cobimetinib in pediatric and young adult
participants with solid tumors with known or potential kinase pathway activation for which
standard therapy has proven to be ineffective or intolerable or for which no curative
standard-of-care treatment options exist. The study will be conducted in two stages: a
dose-escalation stage and an expansion stage at the recommended dose.


Inclusion Criteria:

- For dose-escalation stage (tablets): age at study entry >= 6 years to < 18 years

- For dose-escalation stage (suspension): age at study entry >= 6 months to < 18 years.
Participants <1 year of age will not be enrolled until >= 6 participants >= 1 year to
< 18 years of age have received at least one cycle of therapy with suspension and
until safety and pharmacokinetic assessment of these participants have been conducted.

- For expansion stage: age at study entry to be >= 6 months (>=6 years if suspension is
not available) to < 30 years. Participants >= 6 months to < 1 year of age may not be
enrolled until >= 6 participants >= 1 year to < 18 years of age have received at least
one cycle of therapy with suspension in the dose-escalation phase and until safety and
pharmacokinetic assessment of these participants have been conducted.

- Tumor for which prior treatment has proven to be ineffective or intolerable or for
which no standard therapy exists

- Tumor with known or expected RAS/RAF/MEK/ERK pathway involvement. Diagnosis must be
one of the following tumor types:

Central nervous system gliomas, including high- and low-grade gliomas, and diffuse
intrinsic pontine glioma (DIPG) Embryonal rhabdomyosarcoma and other non-rhabdomyosarcoma
soft tissue sarcomas Neuroblastoma Melanoma Malignant peripheral nerve sheath tumor
Rhabdoid tumors, including atypical teratoid/rhabdoid tumor (ATRT) NF1-associated tumor
(including plexiform neurofibroma), schwannoma, or RASopathy-associated tumor that in the
judgment of the investigator is life threatening, results in severe symptoms (including
severe pain), or is in close proximity to vital structures

- Measurable disease as defined by mINRC, RANO, RECIST v1.1, or evaluable by nuclear
medicine techniques, immunocytochemistry, tumor markers, or other reliable measures

- Availability of tumor tissue at study enrollment

- Lansky performance status or Karnofsky performance status of >= 50 percent

- Life expectancy >= 3 months

- Adequate hematologic, cardiac, and end-organ function

- Body weight must be >= 20 kilograms (kg) if suspension is not available

Exclusion Criteria:

- Pregnant or lactating women

- Close proximity in time to treatment with high-dose chemotherapy, stem-cell rescue,
differentiation therapy, immunotherapy, thoracic or mediastinal radiotherapy, hormonal
therapy, biologic therapy, herbal cancer therapy, hematopoietic growth factor,
investigational therapy, or St. John's wort according to protocol-defined criteria
prior to initiation of study drug

- Inability to swallow oral medications

- Impaired gastrointestinal absorption

- History or evidence of retinal pathology according to protocol-defined criteria,
including serous retinopathy

- History of Grade >= 2 central nervous system (CNS) hemorrhage

- History of CNS hemorrhage within 28 days of study entry. This criterion may be waived
at the investigator's request if the CNS hemorrhage was asymptomatic, with approval of
the Medical Monitor

- Known active infection (excluding fungal infection of the nail beds) within 28 days
prior to initiation of study drug that has not completely resolved

- Major surgical procedure or significant traumatic injury within 4 weeks prior to
initiation of study drug, or anticipation of need for major surgical procedure during
the course of the study

- Prior allogenic bone marrow transplantation or prior solid organ transplantation
We found this trial at
10
sites
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Calgary, Alberta
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Hershey, PA
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Houston, Texas 77030
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1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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Little Rock, AR
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Orlando, Florida 32806
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Palo Alto, CA
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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Phoenix, AZ
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