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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: Completed Phase 1 study of Locally Advanced Malignant Neoplasm and Malignant Solid Tumour, sponsored by Altor BioScience.
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. According to ClinicalTrials.gov, the official US trial registry.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-05 |
| Est. Completion | 2015-02 |
| Phase | Phase 1 |
What the finished NCT01325558 record still lists
NCT01325558 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 121-participant average among 11 other Locally Advanced Malignant Neoplasm trials with a reported enrollment target (75% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT01325558's enrollment target sits among peer trials
30 9th of 11 higher than 3 of 11 other Locally Advanced Malignant Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Locally Advanced Malignant Neoplasm 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.
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