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A Study of ALT-836 in Combination With Gemcitabine for Locally Advanced or Metastatic Solid Tumors
NCT01325558 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01325558
The ClinicalTrials.gov registry entry for NCT01325558 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Altor BioScience, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01325558 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Georgia, Iowa, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01325558?
The interventions under investigation include: ALT-836 in combination with gemcitabine (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01325558?
This trial is sponsored by Altor BioScience, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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