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NCT01532011 · ClinicalTrials.gov registry record · Phase 1
Erlotinib in Combination With Pralatrexate in Advanced Malignancies
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
NCT01532011: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01532011 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 72 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01532011, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest tolerable dose of the combination of erlotinib and pralatrexate that can be given to patients with advanced cancer. The safety of the drug combination will also be studied. Pralatrexate is designed to block the body's ability to make folic acid, a protein that may help cancer tissue to develop and spread. Erlotinib hydrochloride is designed to block proteins that are thought to cause cancer cells to grow. Erlotinib may help slow the growth of tumors.
Primary Outcome
MTD defined by dose limiting toxicities (DLTs) that occur in the first cycle. DLT defined as any Grade 3 or 4 non-hematologic toxicity as defined in the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0. Grade 4 hematologic toxicity lasting 2 weeks or longer despite supportive care. Grade 4 nausea or vomiting \> 5 days despite maximum anti-nausea regimens, and any other Grade 3 non-hematologic toxicity, including symptoms/signs of vascular leak or cytokine release syndrome; or any se
Interventions
- DRUG Pralatrexate
- DRUG Erlotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2012-03 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
What the finished NCT01532011 record still lists
NCT01532011 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 2 interventions - of which Pralatrexate is the first listed.
NCT01532011 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01532011 about?
NCT01532011 is a clinical study titled "Erlotinib in Combination With Pralatrexate in Advanced Malignancies". The goal of this clinical research study is to find the highest tolerable dose of the combination of erlotinib and pralatrexate that can be given to patients with advanced cancer. The safety of the drug combination will also be studied. Pralatrexate is designed to block the body's ability to make f...
What is the current status of trial NCT01532011?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2012-03. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01532011?
The interventions under investigation include: Pralatrexate (DRUG), Erlotinib (DRUG).
Who is sponsoring clinical trial NCT01532011?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01532011's enrollment target sits among peer trials
72 736th of 2000 higher than 1,254 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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