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NCT01611857 · ClinicalTrials.gov registry record · Phase 1

Phase I/II Trial of Tivantinib With FOLFOX for the Treatment of Advanced Solid Tumors and Previously Untreated Metastatic Adenocarcinoma of the Distal Esophagus, Gastroesophageal Junction or Stomach

A Phase 1 study of GastroEsophageal Cancer and Malignant Solid Tumour, sponsored by SCRI Development Innovations.

Completed
Registry status
Phase 1
Development phase
49
Enrollment target
9
Study locations

NCT01611857 is a Phase 1 study of GastroEsophageal Cancer and Malignant Solid Tumour that has completed, run by SCRI Development Innovations. The registered enrollment target is 49 participants, below the 495-participant average among 23 other GastroEsophageal Cancer trials with a reported enrollment target (90% lower). The trial reports 9 study locations across 6 states.

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The verdict

NCT01611857, a Phase 1 study of GastroEsophageal Cancer and Malignant Solid Tumour, has completed, sponsored by SCRI Development Innovations.

COMPLETED
Registry status
Phase 1
Development phase
49 participants
Enrollment target
9
Study locations

Study Summary

This study is a Phase I/II trial of Tivantinib plus FOLFOX for the treatment of patients with advanced solid tumors. In Phase I the Maximum Tolerated Dose (MTD) will be determined; in Phase II patients with first-line metastatic GE cancer will be treated at the MTD. It is hypothesized that the response rate (RR) will be improved from 45% to at least 65% under this regimen.

Conditions Studied

GastroEsophageal Cancer Malignant Solid Tumour

Interventions

  • DRUG FOLFOX
  • DRUG Tivantinib

Study Locations (9)

Florida

  • Florida Cancer Specialists-South - Fort Myers
  • Florida Cancer Specialists-Sarasota - Sarasota
  • Florida Cancer Specialists-North - St. Petersburg

Tennessee

  • Tennessee Oncology - Chattanooga - Chattanooga
  • Tennessee Oncology, PLLC - Nashville

Connecticut

  • Yale University School of Medicine - New Haven

Oklahoma

  • Oklahoma University - Oklahoma City

South Carolina

  • South Carolina Oncology Associates - Columbia

Texas

  • Center for Cancer and Blood Disorders - Fort Worth

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2012-07
Est. Completion 2015-08
Phase Phase 1

Sponsor

SCRI Development Innovations

146 total trials

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What the Registry Record Tells You About NCT01611857

The ClinicalTrials.gov registry entry for NCT01611857 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 495-participant average among 23 other GastroEsophageal Cancer trials with a reported enrollment target (90% lower). The listed sponsor is SCRI Development Innovations, which has 146 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with GastroEsophageal Cancer appearing as the primary indexed condition, and to 2 interventions - of which FOLFOX is the first listed.

NCT01611857 reports 9 study locations spanning 6 distinct geographic areas - top geographies include Florida, Tennessee, Connecticut.

Frequently Asked Questions

What is clinical trial NCT01611857 about?

NCT01611857 is a clinical study titled "Phase I/II Trial of Tivantinib With FOLFOX for the Treatment of Advanced Solid Tumors and Previously Untreated Metastatic Adenocarcinoma of the Distal Esophagus, Gastroesophageal Junction or Stomach". This study is a Phase I/II trial of Tivantinib plus FOLFOX for the treatment of patients with advanced solid tumors. In Phase I the Maximum Tolerated Dose (MTD) will be determined; in Phase II patients with first-line metastatic GE cancer will be treated at the MTD. It is hypothesized that the respo...

What is the current status of trial NCT01611857?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2012-07. Estimated completion is 2015-08.

What conditions does trial NCT01611857 study?

This clinical trial studies the following conditions: GastroEsophageal Cancer, Malignant Solid Tumour.

What interventions are being tested in trial NCT01611857?

The interventions under investigation include: FOLFOX (DRUG), Tivantinib (DRUG).

Who is sponsoring clinical trial NCT01611857?

This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01611857 being conducted?

This trial has 9 study locations across Connecticut, Florida, Oklahoma, South Carolina, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.