Study of CBP501 + Pemetrexed + Cisplatin on MPM (Phase I/II)
Public ClinicalTrials.gov record NCT00700336. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase I/II Study of a Triplet Combination of CBP501, Pemetrexed and Cisplatin in Patients With Advanced Solid Tumors and in Chemotherapy-naïve Patients With Malignant Pleural Mesothelioma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The phase I part of the study is a dose-finding study of escalating doses of CBP501 combined with full-dose cisplatin and pemetrexed in patients with histologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective or would otherwise be eligible for cisplatin and pemetrexed as first-line therapy. The maximum tolerated dose (MTD) will be determined based on DLTs occurring during the first treatment cycle. Pharmacokinetics of the triplet combination will be assessed during the phase I part of the trial. The phase II part will evaluate full-dose cisplatin and pemetrexed combined with CBP501 (at the MTD determined in the phase I part) in previously untreated, unresectable malignant pleural mesothelioma patients. Patients will be randomized in a 2 : 1 ratio to pemetrexed, cisplatin and CBP501 (Arm A) or to pemetrexed and cisplatin (Arm B); randomization will be stratified according to histology and performance status.
Study identification
- NCT ID
- NCT00700336
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 69 participants
Conditions and interventions
Conditions
Interventions
- pemetrexed, cisplatin and CBP501 Drug
- pemetrexed and cisplatin Drug
- pemetrexed, cisplatin and CBP501, dose finding Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2008
- Primary completion
- Jun 30, 2012
- Completion
- Oct 31, 2012
- Last update posted
- Jul 19, 2021
2008 – 2012
United States locations
- U.S. sites
- 12
- U.S. states
- 11
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | 85259 | — |
| Arizona Cancer Center | Tucson | Arizona | 85719-1454 | — |
| City of Hope | Duarte | California | 91010 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Karmanos Cancer Institute/Wayne State University | Detroit | Michigan | 48201 | — |
| Nevada Cancer Institute | Las Vegas | Nevada | 89135 | — |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87131 | — |
| Memorial-Sloan Kettering Cancer Center | New York | New York | 10022 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Penn State Milton S. Hershey Medical Ctr. | Hershey | Pennsylvania | 17033 | — |
| Cancer Therapy & Research Center | San Antonio | Texas | 78229 | — |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00700336, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 19, 2021 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00700336 live on ClinicalTrials.gov.