Pilot Study of Sonidegib and Buparlisib in Treating Patients With Advanced or Metastatic Basal Ce… (NCT02303041) | Clinical Trial Compass
TerminatedPhase 2
Pilot Study of Sonidegib and Buparlisib in Treating Patients With Advanced or Metastatic Basal Cell Carcinoma
Stopped: Business Decision
United States10 participantsStarted 2015-02
Plain-language summary
This pilot trial studies how well sonidegib and buparlisib work in treating patients with basal cell carcinoma that has spread to other places in the body. Sonidegib and buparlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
INCLUSION CRITERIA:
* Able to understand and sign informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Metastatic BCC, histologic confirmation of distant BCC metastasis
* Metastatic disease, target lesion must be measurable using computed tomography (CT) or magnetic resonance imaging (MRI)
* Locally advanced BCC are required to have disease that is considered inoperable due to significant functional compromise or to have a medical contraindication to surgery
* Nevoid BCC syndrome (Gorlin syndrome) may enroll in this study but must meet the criteria for locally advanced or metastatic disease listed above
* COHORT 2 ONLY: A Smoothened inhibitor must have been previously administered as monotherapy
* Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
* Platelets ≥ 80 x10\^9/L
* Hemoglobin (Hb) \> 9 g/dL or values ≥ lower limit of normal (LLN) for site-specific lab
* Total calcium (corrected for serum albumin) within normal limits (biphosphonate use for malignant hypercalcemia control is not allowed)
* Magnesium ≥ the lower limit of normal
* Potassium within normal limits for the institution
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within normal range \[or ≤ 3.0 x upper limit of normal (ULN) if liver metastases are present\]
* Serum bilirubin within normal range (or ≤ 1.5 x ULN if liver metastases are present; or total bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range in patients with well-documented Gilber…