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

Not Applicable

Completed

• Conditions: Solid Tumor
• Interventions: Drug: sirolimus

• Registration Number: NCT02449564
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-24
• Study First Submitted: 2015-05-14
• Study First Submitted QC: 2015-05-19
• Study First Posted: 2015-05-20
• Primary Completion: 2017-09-27
• Study Completion: 2017-11-03
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-15
• Last Update Posted: 2018-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sirolimus	sirolimus	sirolimus 1mg daily

Primary Outcome Measures

Name	Time	Method
progression-free survival	24 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Samsung Medical center; 🇰🇷 Seoul, Korea, Republic of