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Report for Clinical Trial NCT01551030

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase II Study of Buparlisib in Metastatic Transitional Cell Carcinoma of the Urothelium

The purpose of this study is to learn what effects, good and/or bad, Buparlisib has on advanced urothelial cancer. Buparlisib is a pill that works by shutting down some of the signals in cancer cells that make tumors grow. It is being tested in patients in research studies such as this one. As of 2010, more than 80 patients with various types of cancer have received treatment with Buparlisib in research studies. This clinical research study is divided into two parts. The goal of the first part of this study is to learn if the study drug Buparlisib can shrink or slow the growth of cancer in patients with urothelial tumors. The goal of the second part of this study is to learn if the study drug Buparlisib can shrink or slow the growth of urothelial tumors in patients known to have certain genetic alterations that cause these types of tumors. The study doctor will inform the patient which part of the study is currently enrolling participants. Participants in both parts of the study will receive the same treatment and tests. The safety of this drug will also be studied in both parts. The physical state, changes in the size of the tumor, and laboratory findings taken while on-study will help us decide if Buparlisib is safe and effective.

NCT01551030 Metastatic Transitional Cell Carcinoma of the Urothelium
MeSH: Carcinoma Carcinoma, Transitional Cell
HPO: Carcinoma

1 Interventions

Name: Buparlisib

Description: Buparlisib will be administered at a dose of 100 mg orally once daily (two 50 mg capsules) continuously. Intra-patient dose reduction may be required depending on the type and severity of the individual toxicity encountered. Re-staging imaging studies will be performed after every two cycles of treatment (one cycle = 4 weeks). Patients may continue on study as long as they are tolerating therapy and are free of disease progression.

Type: Drug

Buparlisib


Primary Outcomes

Description: at 2 months for the pan-class I selective PI3K inhibitor Buparlisib in patients with metastatic urothelial cancer that has progressed on prior cytotoxic chemotherapy. Response and progression will be evaluated in this study using the international criteria by the Response Evaluation Criteria in Solid Tumors (RECIST).

Measure: progression free survival (PFS) in the Phase II Cohort

Time: 2 months

Measure: progression free survival (PFS) in the Expansion Cohort

Time: 2 months

Secondary Outcomes

Description: as determined by RECIST v1.1 for Buparlisib in patients with progressive metastatic urothelial cancer who have received prior cytotoxic chemotherapy

Measure: response rate in the Phase II Cohort

Time: 2 months

Description: in patients with an activated PI3K pathway.Response and progression will be evaluated in this study using the international criteria by the Response Evaluation Criteria in Solid Tumors (RECIST).

Measure: overall response rate (ORR) in the Phase II Cohort

Time: 2 months

Description: To establish the safety and toxicity of Buparlisib, the frequency of toxicity will be tabulated according to the NCI Common Toxicity Criteria, version 4.0.

Measure: safety in the Phase II Cohort

Time: 2 years

Description: To establish the safety and toxicity of Buparlisib , the frequency of toxicity will be tabulated according to the NCI Common Toxicity Criteria, version 4.0.

Measure: toxicity in the Phase II Cohort

Time: 2 years

Description: Patient samples will be sequenced for mutations in PTEN and PIK3CA as well as for reduced or absent PTEN expression. Patients will be categorized on the basis of PTEN expression levels into three categories: no expression, low expression, or high expression. PTEN levels and PTEN and PIK3CA mutation status (present/absent) will be correlated with PFS using a log rank test, and with response to treatment (complete response/partial response versus no response) using Fisher's exact test.

Measure: To assess markers of activated PI3K pathway

Time: 2 years

Description: as determined by RECIST v1.1

Measure: response rate in Expansion Cohort

Time: 2 months

Description: To establish the safety and toxicity of Buparlisib, the frequency of toxicity will be tabulated according to the NCI Common Toxicity Criteria, version 4.0.

Measure: safety in Expansion Cohort

Time: 2 years

Description: To establish the safety and toxicity of Buparlisib , the frequency of toxicity will be tabulated according to the NCI Common Toxicity Criteria, version 4.0.

Measure: toxicity in the Expansion Cohort

Time: 2 years

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 P13K

- Life expectancy of ≥ 12 weeks - Adequate bone marrow function as shown by: ANC ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L, - Hemoglobin >9 g/dL - Total calcium (corrected for serum albumin) within normal limits (bisphosphonate use for malignant hypercalcemia control is not allowed) - Corrected Calcium = (0.8 * (Normal Albumin - Pt's Albumin)) + Serum Ca - Potassium and magnesium within normal limits - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within normal range [or ≤ 3.0 x upper limit of normal (ULN) if liver metastases are present] - Serum bilirubin within normal range (or ≤ 1.5 x ULN if liver metastases are present; or total bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range in patients with welldocumented Gilbert syndrome) - Serum creatinine ≤ 1.5 x ULN or 24-hour clearance ≥ 50 mL/min - INR ≤ 2 - Serum amylase and lipase ≤ ULN - Fasting plasma glucose ≤ 120 mg/dL (6.7 mmol/L) - Ability to swallow oral medication Exclusion Criteria: - Patients who have received prior treatment with a P13K inhibitor. --- P13K ---



HPO Nodes


HPO:
Carcinoma
Genes 16
POLE MSH2 DKC1 SMARCA4 NLRP1 POLD1 CDKN1B MLH1 RSPO1 FGFR3 BCL10 APC STK11 PTEN APC KIT