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NCT01911598 · ClinicalTrials.gov registry record · Phase 1
A Study of MEHD7945A in Combination With Cisplatin and 5-Fluorouracil (5-FU) or Paclitaxel and Carboplatin in Participants With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN)
A Phase 1 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01911598 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 24 participants.
The verdict
NCT01911598, a Phase 1 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This open-label, multicenter study will evaluate the safety, tolerability, and pharmacokinetics of MEHD7945A in combination with chemotherapy (either cisplatin plus 5-FU or carboplatin plus paclitaxel) in participants with previously untreated R/M SCCHN. There are two stages for each arm in this study: a Dose-limiting Toxicity (DLT)-evaluation stage (Stage I) and a cohort-expansion stage (Stage II). In Stage I, DLTs will be assessed during a DLT Assessment Window of 21 days (i.e., Cycle 1 Day 1 through Cycle 1 Day 21) for both arms. In Stage II, participants will be enrolled to further characterize the safety, pharmacokinetics, and anti-tumor activity of MEHD7945A in combination with cisplatin + 5-FU or carboplatin + paclitaxel at the identified recommended Phase II dose.
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Paclitaxel
- DRUG 5-FU
- DRUG MEHD7945A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2013-09-19 |
| Est. Completion | 2017-06-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01911598
The ClinicalTrials.gov registry entry for NCT01911598 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT01911598 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01911598 about?
NCT01911598 is a clinical study titled "A Study of MEHD7945A in Combination With Cisplatin and 5-Fluorouracil (5-FU) or Paclitaxel and Carboplatin in Participants With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN)". This open-label, multicenter study will evaluate the safety, tolerability, and pharmacokinetics of MEHD7945A in combination with chemotherapy (either cisplatin plus 5-FU or carboplatin plus paclitaxel) in participants with previously untreated R/M SCCHN. There are two stages for each arm in this stu...
What is the current status of trial NCT01911598?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2013-09-19. Estimated completion is 2017-06-22.
What interventions are being tested in trial NCT01911598?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Paclitaxel (DRUG), 5-FU (DRUG), MEHD7945A (DRUG).
Who is sponsoring clinical trial NCT01911598?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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