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NCT03093909 · ClinicalTrials.gov registry record · Phase 1
Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases
A Phase 1 study of Malignant Neoplasms of Female Genital Organs and Malignant Neoplasms of Independent (Primary) Multiple Sites, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT03093909: Recruiting Phase 1 study of Malignant Neoplasms of Female Genital Organs and Malignant Neoplasms of Independent (Primary) Multiple Sites, sponsored by M.D. Anderson Cancer Center.
NCT03093909 is a Phase 1 study of Malignant Neoplasms of Female Genital Organs and Malignant Neoplasms of Independent (Primary) Multiple Sites that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 44 participants, above the 35-participant average among 5 other Malignant Neoplasms of Female Genital Organs trials with a reported enrollment target (26% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03093909, a Phase 1 study of Malignant Neoplasms of Female Genital Organs and Malignant Neoplasms of Independent (Primary) Multiple Sites, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
Study Summary
Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to find the highest tolerable dose of gemcitabine that can be given by inhalation (breathing it as a mist) to patients with solid tumors that have spread to the lungs from other parts of the body. The safety and side effects of this drug will also be studied. This is an investigational study. Gemcitabine is FDA approved and commercially available for the treatment of pancreatic and lung cancer, and other solid tumors. Its administration by inhalation is investigational. The study doctor can explain how the study drug is designed to work. Up to 44 participants will be enrolled in this study. All will take part at MD Anderson.
Primary Outcome
MTD is defined as highest dose level with six patients with at most 1 dose limiting toxicity (DLT) occurring during cycle 1. Dose levels will continue to be increased until 1 participant experiences DLT. If only 1 of 3 participants experiences DLT, 3 additional patients will be entered. Dose escalation conducted via accelerated titration method for first 2 dose levels followed by 3+3 method for remaining dose levels. Cohorts of 1 participant per dose level for first 2 dose levels. If at any tim
Conditions Studied
Interventions
- DRUG Gemcitabine
Study Locations (1)
Texas
- The University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2017-11-22 |
| Est. Completion | 2027-11-30 |
| Phase | Phase 1 |
What NCT03093909 shows while recruiting
NCT03093909 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, above the 35-participant average among 5 other Malignant Neoplasms of Female Genital Organs trials with a reported enrollment target (26% higher).
The record links to 10 conditions, with Malignant Neoplasms of Female Genital Organs appearing as the primary indexed condition, and to 1 intervention - of which Gemcitabine is the first listed.
NCT03093909 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03093909 about?
NCT03093909 is a clinical study titled "Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases". Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to find the highest tolerable dose of gemcitabine that can be given by inhalation (breathing it as a mist) to patients with solid tumors that have sp...
What is the current status of trial NCT03093909?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2017-11-22. Estimated completion is 2027-11-30.
What conditions does trial NCT03093909 study?
This clinical trial studies the following conditions: Malignant Neoplasms of Female Genital Organs, Malignant Neoplasms of Independent (Primary) Multiple Sites, Malignant Neoplasms of Lip Oral Cavity and Pharynx, Melanoma and Other Malignant Neoplasms of Skin, Malignant Neoplasms of Mesothelial and Soft Tissue.
What interventions are being tested in trial NCT03093909?
The interventions under investigation include: Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT03093909?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03093909 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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