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NCT01051934 · ClinicalTrials.gov registry record · Phase 1
A Phase I Trial of SS1 (dsFv) PE38 With Paclitaxel, Carboplatin, and Bevacizumab in Subjects With Unresectable Non-Small Cell Lung Adenocarcinoma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT01051934: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01051934 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 2 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01051934, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
Background: * Advanced cases of non-small-cell lung carcinoma (NSCLC) usually are not successfully treated with standard therapies. Even treatments that attempt to specifically target NSCLC cells have not proved effective. * Researchers are interested in determining whether a combination of the chemotherapy drugs SS1 (dsFv) PE38, paclitaxel, carboplatin, and bevacizumab may be effective in shrinking the size of NSCLC tumors. Three of the drugs (paclitaxel, carboplatin, and bevacizumab) are commercially available, while the other is a drug that is currently being tested to determine its usefulness in cancer treatment. This study will help to determine if the combination of all four drugs is more effective and as safe, safer, or less safe than other drug combinations given to treat NSCLC. Objectives: \- To determine a safe and tolerable dose for the combination of SS1 (dsFv) PE38 with paclitaxel, carboplatin, and bevacizumab in patients with advanced mesothelin-expressing lung adenocarcinoma. Eligibility: * Age \> 18 years of age * Newly diagnosed advanced non-small-cell lung carcinoma * No prior chemotherapy for lung cancer * Individuals at least 18 years of age who have advanced non-small-cell lung carcinoma that has not responded to standard treatments. Design: * The study will last for two 21-day cycles of treatment for the four-drug combination, with additional treatment cycles of carboplatin, paclitaxel, and bevacizumab. * Two to three weeks prior to the study, participants will be screened with a full medical history and physical exam, bone marrow biopsy (we do not do bone marrow biopsies) (if one has not been performed in the last 6 months), computed tomography (CT) or ultrasound scan, tumor measurements, and other tests as required by the researchers. Participants will provide blood and urine samples at this time as well. * During the study, participants will receive SS1 (dsFv) PE38, carboplatin, paclitaxel, and bevacizumab for a maximum of two cycles.
Interventions
- DRUG Bevacizumab
- DRUG Carboplatin
- DRUG Paclitaxel
- DRUG SS1 (dsFv) PE38
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2009-12-29 |
| Est. Completion | 2011-09-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01051934
The ClinicalTrials.gov registry entry for NCT01051934 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Bevacizumab is the first listed.
NCT01051934 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01051934 about?
NCT01051934 is a clinical study titled "A Phase I Trial of SS1 (dsFv) PE38 With Paclitaxel, Carboplatin, and Bevacizumab in Subjects With Unresectable Non-Small Cell Lung Adenocarcinoma". Background: * Advanced cases of non-small-cell lung carcinoma (NSCLC) usually are not successfully treated with standard therapies. Even treatments that attempt to specifically target NSCLC cells have not proved effective. * Researchers are interested in determining whether a combination of the che...
What is the current status of trial NCT01051934?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2009-12-29. Estimated completion is 2011-09-28.
What interventions are being tested in trial NCT01051934?
The interventions under investigation include: Bevacizumab (DRUG), Carboplatin (DRUG), Paclitaxel (DRUG), SS1 (dsFv) PE38 (DRUG).
Who is sponsoring clinical trial NCT01051934?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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