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NCT01064648 · ClinicalTrials.gov registry record · Phase 1
Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma
A Phase 1 study of Pleural Malignant Mesothelioma and Epithelioid Mesothelioma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 117
- Enrollment target
- 20
- Study locations
NCT01064648: Active Phase 1 study of Pleural Malignant Mesothelioma and Epithelioid Mesothelioma, sponsored by National Cancer Institute (NCI).
NCT01064648 is a Phase 1 study of Pleural Malignant Mesothelioma and Epithelioid Mesothelioma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 117 participants, above the 38-participant average among 4 other Pleural Malignant Mesothelioma trials with a reported enrollment target (208% higher). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01064648, a Phase 1 study of Pleural Malignant Mesothelioma and Epithelioid Mesothelioma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 117 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase I/II trial is studying the side effects and best dose of cediranib maleate when given together with pemetrexed disodium and cisplatin and to see how well it works in treating patients with malignant pleural mesothelioma. Drugs used in chemotherapy, pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving pemetrexed disodium and cisplatin together with cediranib maleate may kill more tumor cells.
Primary Outcome
MTD was determined by testing dose-de-escalation to 20mg PO daily on dose de-escalation cohort 1 to 2 with 3 to 6 patients each. MTD reflects the highest dose of drug that did not cause a Dose-Limiting Toxicity (DLT) in \> 33% of participants. Toxicities will be graded according to the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events. Dose-limiting toxicities (DLT) apply only during Cycle 1 and must be drug-related (i.e. possibly, probably or definitely related to on
Conditions Studied
Interventions
- DRUG Cisplatin
- OTHER Laboratory Biomarker Analysis
- OTHER Placebo Administration
- DRUG Cediranib Maleate
- DRUG Pemetrexed Disodium
Study Locations (20)
California
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Kaiser Permanente-Fremont - Fremont
- Kaiser Permanente-Fresno - Fresno
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Kaiser Permanente-Modesto - Modesto
- Kaiser Permanente-Oakland - Oakland
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- Kaiser Permanente-Redwood City - Redwood City
- Kaiser Permanente-Richmond - Richmond
- Kaiser Permanente-Roseville - Roseville
- University of California Davis Comprehensive Cancer Center - Sacramento
- Kaiser Permanente-South Sacramento - Sacramento
- Kaiser Permanente Sacramento Medical Center - Sacramento
- Kaiser Permanente-San Francisco - San Francisco
- Kaiser Permanente-Santa Teresa-San Jose - San Jose
- Kaiser Permanente San Leandro - San Leandro
- Kaiser Permanente-San Rafael - San Rafael
Arkansas
- Highlands Oncology Group - Rogers - Rogers
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2010-03-15 |
| Est. Completion | 2026-03-19 |
| Phase | Phase 1 |
What the registry record for NCT01064648 still lists
NCT01064648 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, above the 38-participant average among 4 other Pleural Malignant Mesothelioma trials with a reported enrollment target (208% higher).
The record links to 4 conditions, with Pleural Malignant Mesothelioma appearing as the primary indexed condition, and to 5 interventions - of which Cisplatin is the first listed.
NCT01064648 names 20 study sites across 2 states, led by California, Arkansas.
Frequently Asked Questions
What is clinical trial NCT01064648 about?
NCT01064648 is a clinical study titled "Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma". This randomized phase I/II trial is studying the side effects and best dose of cediranib maleate when given together with pemetrexed disodium and cisplatin and to see how well it works in treating patients with malignant pleural mesothelioma. Drugs used in chemotherapy, pemetrexed disodium and cispl...
What is the current status of trial NCT01064648?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 117 participants. The study started on 2010-03-15. Estimated completion is 2026-03-19.
What conditions does trial NCT01064648 study?
This clinical trial studies the following conditions: Pleural Malignant Mesothelioma, Epithelioid Mesothelioma, Recurrent Malignant Mesothelioma, Sarcomatoid Mesothelioma.
What interventions are being tested in trial NCT01064648?
The interventions under investigation include: Cisplatin (DRUG), Laboratory Biomarker Analysis (OTHER), Placebo Administration (OTHER), Cediranib Maleate (DRUG), Pemetrexed Disodium (DRUG).
Who is sponsoring clinical trial NCT01064648?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01064648 being conducted?
This trial has 20 study locations across Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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