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NCT06115499 · ClinicalTrials.gov registry record · Phase 2
The PLATINUM Trial: Optimizing Chemotherapy for the Second-Line Treatment of Metastatic BRCA1/2 or PALB2-Associated Metastatic Pancreatic Cancer
A Phase 2 study of Pancreatic Ductal Adenocarcinoma and Pancreatic Adenocarcinoma, sponsored by Alliance for Clinical Trials in Oncology.
- Active
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 20
- Study locations
NCT06115499: Active Phase 2 study of Pancreatic Ductal Adenocarcinoma and Pancreatic Adenocarcinoma, sponsored by Alliance for Clinical Trials in Oncology.
NCT06115499 is a Phase 2 study of Pancreatic Ductal Adenocarcinoma and Pancreatic Adenocarcinoma that is active but no longer recruiting, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 10 participants, below the 601-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06115499, a Phase 2 study of Pancreatic Ductal Adenocarcinoma and Pancreatic Adenocarcinoma, is active but no longer recruiting, sponsored by Alliance for Clinical Trials in Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II/III trial compares the effect of the 3-drug chemotherapy combination of nab-paclitaxel, gemcitabine, plus cisplatin versus the 2-drug chemotherapy combination of nab-paclitaxel plus gemcitabine for the treatment of patients with pancreatic cancer that has spread to other places in the body (metastatic) and a known genetic mutation in the BRCA1, BRCA2, or PALB2 gene.
Primary Outcome
Will be assessed by the proportion of patients who achieve complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) during the protocol treatment. Fisher's exact test will be conducted based on the first 32 patients in each arm who meet PP population criteria.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- DRUG Cisplatin
- PROCEDURE Magnetic Resonance Imaging
- DRUG Gemcitabine
- DRUG Nab paclitaxel
Study Locations (20)
California
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Mercy Cancer Center - Carmichael - Carmichael
- Mercy San Juan Medical Center - Carmichael
- Mercy Cancer Center - Elk Grove - Elk Grove
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- UC San Diego Moores Cancer Center - La Jolla
- UCI Health Laguna Hills - Laguna Hills
- Mercy Cancer Center - Merced
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
Arizona
- CTCA at Western Regional Medical Center - Goodyear
- Cancer Center at Saint Joseph's - Phoenix
Arkansas
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2024-08-13 |
| Est. Completion | 2029-12-09 |
| Phase | Phase 2 |
What the registry record for NCT06115499 still lists
NCT06115499 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 601-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (98% lower).
The record links to 7 conditions, with Pancreatic Ductal Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT06115499 names 20 study sites across 4 states, led by California, Alaska, Arizona.
Frequently Asked Questions
What is clinical trial NCT06115499 about?
NCT06115499 is a clinical study titled "The PLATINUM Trial: Optimizing Chemotherapy for the Second-Line Treatment of Metastatic BRCA1/2 or PALB2-Associated Metastatic Pancreatic Cancer". This phase II/III trial compares the effect of the 3-drug chemotherapy combination of nab-paclitaxel, gemcitabine, plus cisplatin versus the 2-drug chemotherapy combination of nab-paclitaxel plus gemcitabine for the treatment of patients with pancreatic cancer that has spread to other places in the ...
What is the current status of trial NCT06115499?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2024-08-13. Estimated completion is 2029-12-09.
What conditions does trial NCT06115499 study?
This clinical trial studies the following conditions: Pancreatic Ductal Adenocarcinoma, Pancreatic Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v8, Pancreatic Carcinoma, Pancreatic Acinar Cell Carcinoma.
What interventions are being tested in trial NCT06115499?
The interventions under investigation include: Computed Tomography (PROCEDURE), Cisplatin (DRUG), Magnetic Resonance Imaging (PROCEDURE), Gemcitabine (DRUG), Nab paclitaxel (DRUG).
Who is sponsoring clinical trial NCT06115499?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06115499 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06115499's enrollment target sits among peer trials
10 83rd of 84 higher than 1 of 84 other Pancreatic Ductal Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Ductal Adenocarcinoma 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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