Clinical trial · Interventional
The Pilot Study Evaluate the Safety and Efficacy of Sirolimus in Patients With PIK3CA Mutation and/or PIK3CA Amplification Refractory Solid Tumors
NCT02449564CI-TRIAL-00031202completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sirolimus | Drug | Sirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- sirolimus
- description
- sirolimus 1mg daily
- interventionNames
- Drug: sirolimus
Primary outcomes (1)
- measure
- progression-free survival
- timeFrame
- 24 weeks
Secondary outcomes (4)
- measure
- overall response rate
- timeFrame
- 24 weeks
- measure
- overall survival
- timeFrame
- 24 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.