A Study of ALT-801 in Combination With Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial Cancer
Public ClinicalTrials.gov record NCT01326871. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase Ib/II Trial of ALT-801 in Combination With Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01326871
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 68 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 5, 2011
- Primary completion
- Apr 10, 2016
- Completion
- Apr 10, 2016
- Last update posted
- Jun 24, 2024
2011 – 2016
United States locations
- U.S. sites
- 16
- U.S. states
- 12
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Arizona Cancer Center | Tucson | Arizona | 85724 | — |
| UF Health Center at Orlando Health | Orlando | Florida | 32806 | — |
| Martin Health System | Stuart | Florida | 34994 | — |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Robert Lurie Comprehensive Cancer Center of Northwestern University | Chicago | Illinois | 60611 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| University of Kansas Cancer Center | Fairway | Kansas | 66205 | — |
| Karmanos Cancer Center | Detroit | Michigan | 48201 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| Levine Cancer Institute | Charlotte | North Carolina | 28203 | — |
| University of Oklahoma Health Science Center | Oklahoma City | Oklahoma | 73104 | — |
| St. Luke's Hospital and Health Network | Easton | Pennsylvania | 18045 | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | — |
| UPMC Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01326871, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 24, 2024 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01326871 live on ClinicalTrials.gov.