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NCT03308396 · ClinicalTrials.gov registry record · Phase 1
Study of Durvalumab and Guadecitabine in Advanced Kidney Cancer
A Phase 1 study of Kidney Cancer and Clear Cell Renal Cell Carcinoma, sponsored by Ajjai Alva, MD.
- Active
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
- 5
- Study locations
NCT03308396: Active Phase 1 study of Kidney Cancer and Clear Cell Renal Cell Carcinoma, sponsored by Ajjai Alva, MD.
NCT03308396 is a Phase 1 study of Kidney Cancer and Clear Cell Renal Cell Carcinoma that is active but no longer recruiting, run by Ajjai Alva, MD. The registered enrollment target is 57 participants, below the 879-participant average among 60 other Kidney Cancer trials with a reported enrollment target (94% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03308396, a Phase 1 study of Kidney Cancer and Clear Cell Renal Cell Carcinoma, is active but no longer recruiting, sponsored by Ajjai Alva, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
- 5
- Study locations
Study Summary
This is a single arm, multi-centre (via Big Ten Cancer Research Consortium) phase Ib/II study of patients treated with durvalumab 1500 mg IV q 4 weeks in combination with guadecitabine at the recommended phase 2 dose subcutaneously for 5 consecutive days. Eligible patients will have metastatic RCC with a clear cell component, ECOG performance status of 0-1, have received 0-1 prior therapy but no prior anti-PD-1/PD-L1/CTLA4 (Cohort 1, 36 subjects). Study treatment could potentially continue for up to 13 cycles (52 weeks).
Primary Outcome
Number of patients with dose-limiting toxicity (DLT) of the combination of durvalumab and guadecitabine
Conditions Studied
Interventions
- DRUG Durvalumab
- DRUG Guadecitabine
Study Locations (5)
Illinois
- Univerisity of Illinois Cancer Center - Chicago
Iowa
- University of Iowa Hosptials and Clinics - Iowa City
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
Pennsylvania
- Penn State Cancer Institute - Hershey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2017-12-19 |
| Est. Completion | 2023-12 |
| Phase | Phase 1 |
What the registry record for NCT03308396 still lists
NCT03308396 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 879-participant average among 60 other Kidney Cancer trials with a reported enrollment target (94% lower).
The record links to 3 conditions, with Kidney Cancer appearing as the primary indexed condition, and to 2 interventions - of which Durvalumab is the first listed.
NCT03308396 lists 5 locations in 5 states (Illinois, Iowa, Michigan).
Frequently Asked Questions
What is clinical trial NCT03308396 about?
NCT03308396 is a clinical study titled "Study of Durvalumab and Guadecitabine in Advanced Kidney Cancer". This is a single arm, multi-centre (via Big Ten Cancer Research Consortium) phase Ib/II study of patients treated with durvalumab 1500 mg IV q 4 weeks in combination with guadecitabine at the recommended phase 2 dose subcutaneously for 5 consecutive days. Eligible patients will have metastatic RCC w...
What is the current status of trial NCT03308396?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2017-12-19. Estimated completion is 2023-12.
What conditions does trial NCT03308396 study?
This clinical trial studies the following conditions: Kidney Cancer, Clear Cell Renal Cell Carcinoma, Advanced Kidney Cancer.
What interventions are being tested in trial NCT03308396?
The interventions under investigation include: Durvalumab (DRUG), Guadecitabine (DRUG).
Who is sponsoring clinical trial NCT03308396?
This trial is sponsored by Ajjai Alva, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03308396 being conducted?
This trial has 5 study locations across Illinois, Iowa, Michigan, New Jersey, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03308396's enrollment target sits among peer trials
57 33rd of 60 higher than 28 of 60 other Kidney Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Cancer 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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