The Pilot Study Evaluate the Safety and Efficacy of Sirolimus in Patients With PIK3CA Mutation and/or PIK3CA Amplification Refractory Solid Tumors

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02449564

Enrollment

Registered

2015-05-20

Start date

2014-11-24

Completion date

2017-11-03

Last updated

2018-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor

Brief summary

This study is a single-arm, phase II study of sirolimus in patient with PIK3CA mutation and PIK3CA amplication Refractory solid tumors. sirolimus 1mg will be administered orally qd daily. To investigate the efficacy of sirolimus in patients with PIK3CA mutation and PIK3CA amplication Refractory solid tumors.

Interventions

DRUGsirolimus

sirolimus 1mg daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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 and/or PIK3CA mutation Refractory Solid Tumors. 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 ≥ 100 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.

Design outcomes

Primary

Measure	Time frame
progression-free survival	24 weeks

Secondary

Measure	Time frame
overall response rate	24 weeks
overall survival	24 weeks
Time to progressive	24 weeks
Number of subjects with Adverse Events as a measure of toxicity profile	24 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026