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NCT02726997 · ClinicalTrials.gov registry record · Phase 1
Matched Paired Pharmacodynamics and Feasibility Study of Durvalumab in Combination With Chemotherapy in Frontline Ovarian Cancer (N-Dur)
A Phase 1 study of Stage III Fallopian Tube Cancer AJCC v7 and Stage III Ovarian Cancer AJCC v6 and v7, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT02726997: Active Phase 1 study of Stage III Fallopian Tube Cancer AJCC v7 and Stage III Ovarian Cancer AJCC v6 and v7, sponsored by M.D. Anderson Cancer Center.
NCT02726997 is a Phase 1 study of Stage III Fallopian Tube Cancer AJCC v7 and Stage III Ovarian Cancer AJCC v6 and v7 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 18 participants, below the 27-participant average among 3 other Stage III Fallopian Tube Cancer AJCC v7 trials with a reported enrollment target (33% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02726997, a Phase 1 study of Stage III Fallopian Tube Cancer AJCC v7 and Stage III Ovarian Cancer AJCC v6 and v7, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial studies how well durvalumab works when given in combination with carboplatin and paclitaxel in treating patients with stage III-IV ovarian, primary peritoneal, or fallopian tube cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving durvalumab in combination with carboplatin and paclitaxel may be a better treatment for ovarian, primary peritoneal, or fallopian tube cancer.
Primary Outcome
Paired t-test with a 2-sided significance level of 0.05 used to test whether the change in biomarker expression from pre-treatment to post-treatment with Durvalumab is different from 0.
Conditions Studied
Interventions
- DRUG Carboplatin
- BIOLOGICAL Durvalumab
- OTHER Laboratory Biomarker Analysis
- DRUG Paclitaxel
- OTHER Pharmacological Study
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2016-07-06 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What the registry record for NCT02726997 still lists
NCT02726997 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 27-participant average among 3 other Stage III Fallopian Tube Cancer AJCC v7 trials with a reported enrollment target (33% lower).
The record links to 10 conditions, with Stage III Fallopian Tube Cancer AJCC v7 appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT02726997 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02726997 about?
NCT02726997 is a clinical study titled "Matched Paired Pharmacodynamics and Feasibility Study of Durvalumab in Combination With Chemotherapy in Frontline Ovarian Cancer (N-Dur)". This phase I/II trial studies how well durvalumab works when given in combination with carboplatin and paclitaxel in treating patients with stage III-IV ovarian, primary peritoneal, or fallopian tube cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune sys...
What is the current status of trial NCT02726997?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2016-07-06. Estimated completion is 2027-12-31.
What conditions does trial NCT02726997 study?
This clinical trial studies the following conditions: Stage III Fallopian Tube Cancer AJCC v7, Stage III Ovarian Cancer AJCC v6 and v7, Stage III Primary Peritoneal Cancer AJCC v7, Stage IIIA Fallopian Tube Cancer AJCC v7, Stage IIIA Ovarian Cancer AJCC v6 and v7.
What interventions are being tested in trial NCT02726997?
The interventions under investigation include: Carboplatin (DRUG), Durvalumab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Paclitaxel (DRUG), Pharmacological Study (OTHER).
Who is sponsoring clinical trial NCT02726997?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02726997 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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