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NCT01326871 · ClinicalTrials.gov registry record · Phase 1
A Study of ALT-801 in Combination With Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial Cancer
A Phase 1 study, sponsored by Altor BioScience.
- Completed
- Registry status
- Phase 1
- Development phase
- 68
- Enrollment target
NCT01326871 is a Phase 1 study that has completed, run by Altor BioScience. The registered enrollment target is 68 participants.
The verdict
NCT01326871, a Phase 1 study, has completed, sponsored by Altor BioScience.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 68 participants
- Enrollment target
Study Summary
This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose-escalation study of ALT-801 in a biochemotherapy regimen either containing cisplatin and gemcitabine or containing gemcitabine alone in patients who have muscle invasive or metastatic urothelial cancer of bladder, renal pelvis, ureters and urethra. The purpose of this study is to evaluate the safety, determine the maximum tolerated dose (MTD) and the recommended dose (RD), and assess the anti-tumor response of ALT-801 in combination with cisplatin and gemcitabine or ALT-801 in combination with gemcitabine alone. The pharmacokinetic profile of ALT-801 in combination with cisplatin and gemcitabine will also be assessed. The study includes a dose escalation phase (Phase Ib) and a dose expansion phase (Phase II). Phase II has two treatment groups, Expansion Group 1 and Expansion Group 2. Expansion Group 2 is for platinum-refractory patients, consisting of two treatment arms based on the patient's renal function. Patients will enroll to Expansion Group 2 after stage 1 of the Group 1 expansion is complete.
Interventions
- DRUG Cisplatin
- DRUG Gemcitabine
- BIOLOGICAL ALT-801
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2011-09-06 |
| Est. Completion | 2016-04-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01326871
The ClinicalTrials.gov registry entry for NCT01326871 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Altor BioScience, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.
NCT01326871 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01326871 about?
NCT01326871 is a clinical study titled "A Study of ALT-801 in Combination With Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial Cancer". This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose-escalation study of ALT-801 in a biochemotherapy regimen either containing cisplatin and gemcitabine or containing gemcitabine alone in patients who have muscle invasive or metastatic urothelial cancer of bladder, renal...
What is the current status of trial NCT01326871?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2011-09-06. Estimated completion is 2016-04-11.
What interventions are being tested in trial NCT01326871?
The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), ALT-801 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01326871?
This trial is sponsored by Altor BioScience, which has 14 total clinical trials registered on ClinicalTrials.gov.
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