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NCT01009346 · ClinicalTrials.gov registry record · Phase 1
RAD001 in Combination With Cetuximab and Cisplatin in Recurrent and Metastatic SCCHN
A Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01009346: Clinical Trial Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT01009346 is a Phase 1 study that was terminated before completion, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01009346, a Phase 1 study, was terminated before completion, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
1.Phase I: To estimate the Maximum Tolerated Dose (MTD) of RAD001 in combination with cetuximab and cisplatin for treatment of metastatic squamous cell cancer of the head and neck (SCCHN). Secondary Objectives 1.To assess the toxicity of RAD001 in combination with weekly cetuximab and cisplatin on days 1 and 8 of each 28 day cycle in patients with recurrent or metastatic SCCHN,
Primary Outcome
MTD will be defined as a) the dose of RAD001 producing DLT in 0-1 out of 6 patients, or b) the dose level below the dose which produced DLT in \<2 out of 6 patients, or c) the dose of 10mg po qd with less than 33% rate of DLT
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Cetuximab
- DRUG RAD001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2009-10 |
| Est. Completion | 2011-03 |
| Phase | Phase 1 |
Why NCT01009346 stopped before completion
NCT01009346 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.
NCT01009346 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01009346 about?
NCT01009346 is a clinical study titled "RAD001 in Combination With Cetuximab and Cisplatin in Recurrent and Metastatic SCCHN". 1.Phase I: To estimate the Maximum Tolerated Dose (MTD) of RAD001 in combination with cetuximab and cisplatin for treatment of metastatic squamous cell cancer of the head and neck (SCCHN). Secondary Objectives 1.To assess the toxicity of RAD001 in combination with weekly cetuximab and cisplatin on...
What is the current status of trial NCT01009346?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2009-10. Estimated completion is 2011-03.
What interventions are being tested in trial NCT01009346?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Cetuximab (DRUG), RAD001 (DRUG).
Who is sponsoring clinical trial NCT01009346?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01009346's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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