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NCT01548144 · ClinicalTrials.gov registry record · Phase 1
Pazopanib or Pemetrexed and Crizotinib in Advanced Cancer
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 178
- Enrollment target
NCT01548144: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01548144 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 178 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (197% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01548144, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 178 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest tolerable dose of the combination of Xalkori (crizotinib) either with Votrient (pazopanib) or Alimta (pemetrexed) or of the combination of 3 study drugs that can be given to patients with advanced cancer. The safety of these drug combinations will also be studied. Crizotinib is designed to block a protein called ALK, which is involved in cancer cell growth and survival. Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for tumor growth. This may prevent or slow the growth of cancer cells. Pemetrexed is designed to block proteins that may cause tumors to grow. This is an investigational study. Crizotinib is FDA approved and commercially available for the treatment of locally advanced or metastatic non-small cell lung cancer. Pazopanib is FDA approved and commercially available for treatment of advanced renal cell carcinoma. Pemetrexed is FDA approved and commercially available for the treatment of non-small cell lung cancer. The combination of crizotinib with pazopanib, crizotinib with pemetrexed, pazopanib with pemetrexed, and giving all 3 drugs together to patients with advanced cancer is investigational. Up to 364 patients will take part in this study. All will be enrolled at MD Anderson.
Primary Outcome
If not more than 33% of participants in cohort develop dose limiting toxicity (DLT), this cohort considered MTD. MTD defined by DLTs that occur in first cycle (4 weeks). DLT defined as: Clinically grade 3 or 4 non-hematologic toxicity. Grade 4 hematologic toxicity lasting 3 weeks or longer. Grade 4 nausea or vomiting \> 5 days despite maximum anti-nausea regimens. Grade 3 non-hematologic toxicity including symptoms/signs of vascular leak or cytokine release syndrome; or any severe or life-threat
Interventions
- DRUG Pemetrexed
- DRUG Pazopanib
- DRUG Crizotinib (Xalkori)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 178 participants |
| Start Date | 2012-04 |
| Est. Completion | 2021-08-26 |
| Phase | Phase 1 |
Why NCT01548144 stopped before completion
NCT01548144 is an interventional study that assigns participants to a tested intervention. The registered 178 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (197% higher).
The record links to 0 conditions, and to 3 interventions - of which Pemetrexed is the first listed.
NCT01548144 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01548144 about?
NCT01548144 is a clinical study titled "Pazopanib or Pemetrexed and Crizotinib in Advanced Cancer". The goal of this clinical research study is to find the highest tolerable dose of the combination of Xalkori (crizotinib) either with Votrient (pazopanib) or Alimta (pemetrexed) or of the combination of 3 study drugs that can be given to patients with advanced cancer. The safety of these drug combin...
What is the current status of trial NCT01548144?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 178 participants. The study started on 2012-04. Estimated completion is 2021-08-26.
What interventions are being tested in trial NCT01548144?
The interventions under investigation include: Pemetrexed (DRUG), Pazopanib (DRUG), Crizotinib (Xalkori) (DRUG).
Who is sponsoring clinical trial NCT01548144?
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 NCT01548144's enrollment target sits among peer trials
178 311th of 2000 higher than 1,688 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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