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NCT01325558 · ClinicalTrials.gov registry record · Phase 1

A Study of ALT-836 in Combination With Gemcitabine for Locally Advanced or Metastatic Solid Tumors

A Phase 1 study of Locally Advanced Malignant Neoplasm and Malignant Solid Tumour, sponsored by Altor BioScience.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target
4
Study locations

NCT01325558 is a Phase 1 study of Locally Advanced Malignant Neoplasm and Malignant Solid Tumour that has completed, run by Altor BioScience. The registered enrollment target is 30 participants, below the 121-participant average among 11 other Locally Advanced Malignant Neoplasm trials with a reported enrollment target (75% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT01325558, a Phase 1 study of Locally Advanced Malignant Neoplasm and Malignant Solid Tumour, has completed, sponsored by Altor BioScience.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target
4
Study locations

Study Summary

This is a Phase I, open-label, multi-center, competitive enrollment and dose-escalation study of ALT-836 in combination with standard of care gemcitabine in participants who have locally advanced or metastatic solid tumors. The purpose of this study is to determine the maximum tolerated dose (MTD), and to assess the safety and pharmacokinetic profile of ALT-836 given with gemcitabine. The clinical benefit, progression-free survival and overall survival of study participants will also be assessed.

Conditions Studied

Locally Advanced Malignant Neoplasm Malignant Solid Tumour

Interventions

  • BIOLOGICAL ALT-836 in combination with gemcitabine

Study Locations (4)

Georgia

  • Emory University, Winship Cancer Institute - Atlanta

Iowa

  • University of Iowa Hospitals and Clinics - Iowa City

New York

  • University of Rochester Medical Center, James P. Wilmot Cancer Center - Rochester

North Carolina

  • Carolinas Hematology-Oncology Associates - Charlotte

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2011-05
Est. Completion 2015-02
Phase Phase 1

Sponsor

Altor BioScience

14 total trials

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What the Registry Record Tells You About NCT01325558

The ClinicalTrials.gov registry entry for NCT01325558 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 121-participant average among 11 other Locally Advanced Malignant Neoplasm trials with a reported enrollment target (75% lower). The listed sponsor is Altor BioScience, which has 14 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Locally Advanced Malignant Neoplasm appearing as the primary indexed condition, and to 1 intervention - of which ALT-836 in combination with gemcitabine is the first listed.

NCT01325558 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Georgia, Iowa, New York.

Frequently Asked Questions

What is clinical trial NCT01325558 about?

NCT01325558 is a clinical study titled "A Study of ALT-836 in Combination With Gemcitabine for Locally Advanced or Metastatic Solid Tumors". This is a Phase I, open-label, multi-center, competitive enrollment and dose-escalation study of ALT-836 in combination with standard of care gemcitabine in participants who have locally advanced or metastatic solid tumors. The purpose of this study is to determine the maximum tolerated dose (MTD), ...

What is the current status of trial NCT01325558?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2011-05. Estimated completion is 2015-02.

What conditions does trial NCT01325558 study?

This clinical trial studies the following conditions: Locally Advanced Malignant Neoplasm, Malignant Solid Tumour.

What interventions are being tested in trial NCT01325558?

The interventions under investigation include: ALT-836 in combination with gemcitabine (BIOLOGICAL).

Who is sponsoring clinical trial NCT01325558?

This trial is sponsored by Altor BioScience, which has 14 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01325558 being conducted?

This trial has 4 study locations across Georgia, Iowa, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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