Phase
Condition
Neoplasms
Non-small Cell Lung Cancer
Pancreatic Disorders
Treatment
DCC-3084
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
General Inclusion Criteria ModA Part 1 and 2:
Able to take oral medication
If a female is of childbearing potential, must have a negative pregnancy test priorto enrollment and all participants agree to follow the contraception requirements
Adequate organ function and electrolytes
Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of 0 to 1 atScreening
Has a life expectancy of more than 6 months
In addition to these general inclusion criteria, participants must meet all themodule cohort-specific inclusion criteria
Inclusion Criteria ModA Part 1 Cohort Specific:
Pathologically confirmed diagnosis of solid cancer and documentation of Kirsten ratsarcoma (KRAS), Harvey rat sarcoma virus (HRAS), neuroblastoma ras viral oncogenehomolog (NRAS), v-raf murine sarcoma viral oncogene homolog B1 (BRAF), v-raf murinesarcoma viral oncogene homolog C1(CRAF), and/or neurofibromatosis 1 (NF1) mutation
Have exhausted all available standard of care therapies that are known to providebenefit for the participant's condition, as judged by the Investigator
Inclusion Criteria ModA Part 2 Cohort Specific:
Documented BRAF gene mutation
Pathologically confirmed diagnosis with PD after at least one prior line of therapyin the advanced or metastatic setting
Exclusion
Exclusion Criteria:
General Exclusion Criteria ModA Part 1 and 2:
Prior treatment with certain BRAF dimer inhibitors
Female participant is pregnant or lactating
Received any prior or concurrent medications or therapies known to be prohibitedwith DCC-3084 within 14 days
Received any prior antitumor therapy or any investigational therapy within aspecified timeframe prior to first dose of DCC-3084
Known allergy or hypersensitivity to any component of the study drug
Invasive malignancy within 2 years prior to the first dose of study drug other thanthe study indication or specific types of cancer treated with curative intent
Have not recovered from all clinically relevant toxicities from prior therapy
Impaired cardiac function
History of recent thrombotic or embolic events
Malabsorption syndrome or other illness that could affect oral absorption
Major surgery within 28 days of the first dose of study drug
In addition to the general exclusion criteria, participants will also be excludedbased on the cohort-specific exclusion criteria
Exclusion Criteria: Module A Part 2 Cohort Specific:
• Has known co-occurring mutation of KRAS, HRAS, NRAS, NF1, epidermal growth factor receptor, Phosphoinositide-3-kinase, catalytic, alpha polypeptide (PI3KCA), or Phosphatase and TENsin homolog deleted on chromosome 10 (PTEN)
Study Design
Connect with a study center
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California 90033
United StatesSite Not Available
University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
San Francisco, California 94158
United StatesSite Not Available
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles 5368361, California 5332921 90033
United StatesSite Not Available
University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
San Francisco 5391959, California 5332921 94158
United StatesSite Not Available
SCRI HealthONE
Denver, Colorado 80218
United StatesSite Not Available
SCRI HealthONE
Denver 5419384, Colorado 5417618 80218
United StatesSite Not Available
SCRI Florida Cancer Specialists
Orlando, Florida 32827
United StatesSite Not Available
SCRI Florida Cancer Specialists
Orlando 4167147, Florida 4155751 32827
United StatesSite Not Available
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United StatesSite Not Available
Dana-Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215
United StatesSite Not Available
Roswell Park Comprehensive Cancer Center
Buffalo, New York 14263
United StatesSite Not Available
Roswell Park Comprehensive Cancer Center
Buffalo 5110629, New York 5128638 14263
United StatesSite Not Available
SCRI Oncology Partners
Nashville, Tennessee 37203
United StatesSite Not Available
SCRI Oncology Partners
Nashville 4644585, Tennessee 4662168 37203
United StatesSite Not Available
NEXT Oncology
San Antonio, Texas 78229
United StatesSite Not Available
NEXT Oncology
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available
NEXT Oncology Virginia
Fairfax, Virginia 22031
United StatesSite Not Available
NEXT Oncology Virginia
Fairfax 4758023, Virginia 6254928 22031
United StatesSite Not Available

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