Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
EMD Serono
With
Sanofi
Age
18–82
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject with advanced solid tumors for which there is no approved therapy:
* Advanced solid tumor with diagnosed alteration in one or more of the following genes (PTEN, BRAF, KRAS, NRAS, PI3KCA, ErbB1, ErbB2, MET, RET, c-KIT, GNAQ, GNA11 and/or
* A histologically or cytologically confirmed diagnosis of one of the following solid tumors: pancreatic, thyroid, colorectal, non-small cell lung, endometrial, renal, breast, ovarian carcinoma and melanoma
Subject with archived tumor tissue available for transfer to the Sponsor
Subject enrolled at lower dose level cohorts and MTD expansion cohorts must have tumor available for biopsy and agree to pre-treatment and on-treatment tumor biopsies
Subject has measurable or evaluable disease by response evaluation criteria in solid tumors (RECIST) v1.1
Subject is aged greater than or equal to (\>=) 18 years
You may not be if
* Relapsed or refractory Kirsten rat sarcoma viral oncogene homolog (KRAS) or neuroblastoma RAS viral oncogene homolog (NRAS) mutated metastatic non-small cell lung cancer (NSCLC) with no approved therapies, or
* Relapsed or refractory metastatic triple negative breast cancer defined as estrogen, progesterone and HER2 negative carcinoma of the breast with no approved therapies, or
* Relapsed or refractory metastatic colorectal cancer (CRC) with dual KRAS and PIK3CA mutation with no approved therapies, or
* BRAF V600E/K mutated unresectable or metastatic melanoma after progression on B-Raf proto-oncogene, serine/threonine kinase (BRAF) inhibitors
Subject has been previously treated with a PI3K inhibitor or a MEK inhibitor and taken off treatment due to treatment related adverse events
Subject has received:
Chemotherapy, immunotherapy, hormonal therapy, biologic therapy, or any other anti-cancer therapy within 28 days of trial drug treatment
Any investigational agent within 28 days of trial drug treatment
Extensive prior radiotherapy on more than 30% bone marrow reserves, or prior bone marrow/stem cell transplantation
Subject has not recovered from toxicity due to prior therapy
Subject has poor organ and marrow function as defined in the protocol
Subject has a history of central nervous system metastases, unless subject has been previously treated for CNS metastases
Subject has a history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease
Subject has a history of recent major surgery or trauma within the last 28 days.
Subject has participated in another clinical trial within the past 30 days
