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

Samsung Medical Center

Status: Completed

Conditions: Solid Tumor

Treatments: Drug: sirolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT02449564

2014-10-030

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

5 participants in 1 patient group

sirolimus

Experimental group

Description:

sirolimus 1mg daily

Treatment:

Drug: sirolimus