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NCT01551030 · ClinicalTrials.gov registry record · Phase 2

Buparlisib in Metastatic Transitional Cell Carcinoma of the Urothelium

A Phase 2 study of Metastatic Transitional Cell Carcinoma of the Urothelium, sponsored by Memorial Sloan Kettering Cancer Center.

Completed
Registry status
Phase 2
Development phase
19
Enrollment target
5
Study locations

NCT01551030: Completed Phase 2 study of Metastatic Transitional Cell Carcinoma of the Urothelium, sponsored by Memorial Sloan Kettering Cancer Center.

NCT01551030 is a Phase 2 study of Metastatic Transitional Cell Carcinoma of the Urothelium that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). The trial reports 5 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01551030, a Phase 2 study of Metastatic Transitional Cell Carcinoma of the Urothelium, has completed, sponsored by Memorial Sloan Kettering Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
19 participants
Enrollment target
5
Study locations

Study Summary

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.

Primary Outcome

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).

Interventions

  • DRUG Buparlisib

Study Locations (5)

New York

  • Memorial Sloan-Kettering Cancer Center @ Suffolk - Commack
  • Memorial Sloan Kettering Cancer Center - New York
  • Memorial Sloan-Kettering Cancer Center at Mercy Medical Center - Rockville Centre
  • Memoral Sloan Kettering Cancer Center@Phelps - Sleepy Hollow

New Jersey

  • Memorial Sloan-Kettering at Basking Ridge - Basking Ridge

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2012-03
Est. Completion 2020-09-02
Phase Phase 2
Memorial Sloan Kettering Cancer Center

1,884 total trials

What the finished NCT01551030 record still lists

NCT01551030 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).

The record links to 1 condition, with Metastatic Transitional Cell Carcinoma of the Urothelium appearing as the primary indexed condition, and to 1 intervention - of which Buparlisib is the first listed.

NCT01551030 lists 5 locations in 2 states (New York, New Jersey).

Frequently Asked Questions

What is clinical trial NCT01551030 about?

NCT01551030 is a clinical study titled "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 20...

What is the current status of trial NCT01551030?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2012-03. Estimated completion is 2020-09-02.

What conditions does trial NCT01551030 study?

This clinical trial studies the following conditions: Metastatic Transitional Cell Carcinoma of the Urothelium.

What interventions are being tested in trial NCT01551030?

The interventions under investigation include: Buparlisib (DRUG).

Who is sponsoring clinical trial NCT01551030?

This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01551030 being conducted?

This trial has 5 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT01551030's enrollment target sits among peer trials

19 1894th of 2000 higher than 103 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01551030, the US trial registry maintained by the National Library of Medicine. NCT01551030 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.