Trial of MEK Inhibitor and PI3K/mTOR Inhibitor in Subjects With Locally Advanced or Metastatic Solid Tumors
This research trial is testing a combination of two experimental drugs, MSC1936369B (Mitogen-activated protein extracellular signal-regulated kinase (MEK) Inhibitor) and SAR245409 (Phosphatidylinositol 3-kinase (Pi3K)/Mammalian Target of Rapamycin (mTOR) inhibitor), in the treatment of locally advanced or metastatic solid tumors. The primary purpose of the study is to determine the maximum tolerated dose of the drug combination.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 2 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Mar 7, 2017 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- EMD Serono
- Interventions being studied
- Drug: MSC1936369B (pimasertib); Drug: SAR245409 (PI3K and mTOR inhibitor); Drug: MSC1936369B (pimasertib); Drug: SAR245409 (PI3K and mTOR inhibitor)
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- Subjects enrolled in disease specific expansion cohorts must fulfill all the inclusion/
- listed above with the following restriction to the Inclusion Criterion number 1:
- 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
- Other protocol-defined inclusion criteria could apply
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Pinnacle Oncology HematologyScottsdale, Arizona
- Cedars Sinai Medical CenterLos Angeles, California
- Massachusetts General HospitalBoston, Massachusetts
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Sarah Cannon Research InstituteNashville, Tennessee
- Cancer Therapy and Research CenterSan Antonio, Texas
- Merck Serono Research SiteMilan
- Merck Serono Research SiteMadrid
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 7, 2017. Always confirm current availability with the study team.