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

Solid Tumor Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02449564
• Other study ID #: 2014-10-030
• Status: Completed
• Phase: N/A
• First received: May 14, 2015
• Last updated: January 15, 2018
• Start date: November 24, 2014
• Est. completion date: November 3, 2017

Study information

• Verified date: January 2018
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: November 3, 2017
• Est. primary completion date: September 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Drug:
• sirolimus
sirolimus 1mg daily

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival		24 weeks
Secondary	overall response rate		24 weeks
Secondary	overall survival		24 weeks
Secondary	Time to progressive		24 weeks
Secondary	Number of subjects with Adverse Events as a measure of toxicity profile		24 weeks