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

NCT ID: NCT02449564

Last Updated: 2018-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-24
• Study Completion Date: 2017-11-03

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.

Conditions

Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

sirolimus

sirolimus 1mg daily

Group Type: EXPERIMENTAL

sirolimus

Intervention Type: DRUG

sirolimus 1mg daily

Interventions

sirolimus

sirolimus 1mg daily

Intervention Type: DRUG

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 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jeeyun Lee

MD,PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jee yun Lee, MD,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center,Seoul,Korea

Locations

Samsung Medical center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2014-10-030

Identifier Type: -

Identifier Source: org_study_id