Clinical trial NCT02449538: Study to Evaluate the Safety and Efficacy of Everolimus, in Subjects With PIK3CA Amplification, PTEN Loss and PIK3CA Mutation Refractory Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Solid Tumor
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-05-20
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a single-arm, phase II study of everolimus in patients with PTEN loss ,PIK3CA mutation and PIK3CA amplification Refractory Solid Tumors .

Everolimus 10 mg will be administered orally qd daily.

To investigate the efficacy and safety of everolimus in patients with PTEN loss ,PIK3CA mutantion and PIK3CA amplification Refractory Solid Tumors.


Eligibility criteria: Inclusion Criteria:

1. Provision of fully informed consent prior to any study specific procedures.
2. Patients must be ≥20 years of age.
3. PIK3CA amplification, PTEN loss and PIK3CA mutation Refractory Solid Tumors that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy.
4. ECOG performance status 0-2.
5. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
6. Adequate Organ Function Laboratory Values

   * Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 75 x 109/L
   * bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases)
   * creatinine ≤1.5 x UNL
7. Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.
8. Adequate heart function.

Exclusion Criteria:

1. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
2. Has known active central nervous system (CNS) metastases.
3. Has an active infection requiring systemic therapy.
4. Pregnancy or breast feeding
5. Patients with cardiac problem.
6. KRAS mutation (codon 12 or 13) or BRAF mutation (V600)
7. Any previous treatment with everolimus

Primary outcomes:
measure: overall response rate
timeFrame: 24 weeks
Secondary outcomes:
measure: progression free survival
timeFrame: 24 weeks
measure: overall survival
timeFrame: 24 weeks
measure: Number of subjects with Adverse Events as a measure of toxicity profile
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical center
Study officials:
affiliation: Samsung Medical Center,Seoul,Korea
name: Jee yun Lee, MD,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim ST, Lee J, Park SH, Park JO, Park YS, Kang WK, Lim HY. Prospective phase II trial of everolimus in PIK3CA amplification/mutation and/or PTEN loss patients with advanced solid tumors refractory to standard therapy. BMC Cancer. 2017 Mar 23;17(1):211. doi: 10.1186/s12885-017-3196-6.