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NCT00942825 · ClinicalTrials.gov registry record · Phase 2
Triplet Combination First Line Treatment in Non Small Cell Lung Cancer (NSCLC)
A Phase 2 study, sponsored by CanBas Co..
- Completed
- Registry status
- Phase 2
- Development phase
- 195
- Enrollment target
NCT00942825 is a Phase 2 study that has completed, run by CanBas Co.. The registered enrollment target is 195 participants.
The verdict
NCT00942825, a Phase 2 study, has completed, sponsored by CanBas Co..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 195 participants
- Enrollment target
Study Summary
This is a randomized, open-label, multicenter, phase II study to compare a triplet combination of CBP501, pemetrexed and cisplatin with pemetrexed/cisplatin when administered to patients with locally advanced (stage IIIB with malignant pleural effusion or pericardial effusion) or metastatic (stage IV) non-squamous NSCLC as consecutive i.v. infusions according to a once-every-3-weeks schedule. The protocol will evaluate full-dose cisplatin and pemetrexed with or without CBP501. Patients will be randomized in a 1:1 ratio to pemetrexed, cisplatin and CBP501 (Arm A) or pemetrexed and cisplatin (Arm B). Randomization will be stratified according to whether or not patients are eligible for bevacizumab therapy. Preclinical and clinical findings that support this protocol are: * CBP501 has exhibited interesting preclinical activity in various lung cancer cell lines. * Synergism was documented with CBP501/cisplatin in the preclinical studies with lung cancer cell lines. * The dose-limiting toxicity (DLT) of CBP501 was rapid onset allergic reaction, as was suggested by preclinical toxicology. Other toxicities were quite limited. No evidence of potentiation of either CBP501 or cisplatin toxicity was found in the combination phase I trial, and the toxicity of the combination, primarily related to cisplatin, is manageable. It is expected that CBP501 and pemetrexed will display non-overlapping toxicity profiles in combination, given that hematological toxicity and gastrointestinal toxicity are the principal toxicity types of the latter. * Given the acceptable safety of the cisplatin/ pemetrexed combination, it is anticipated that the addition of CBP501 to this combination can be evaluated without excessive risk in the phase II programs. * The phase I study of CBP501 in combination with pemetrexed/cisplatin (phase I part of the mesothelioma program) did not show DLTs or evidence of enhancement of toxicities with the triplet combination. The RD of CBP501 25 mg/m², cisplatin 75 m
Interventions
- DRUG CBP501 + Cisplatin + Pemetrexed
- DRUG Cisplatin + Pemetrexed
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2009-04 |
| Est. Completion | 2013-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00942825
The ClinicalTrials.gov registry entry for NCT00942825 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CanBas Co., which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which CBP501 + Cisplatin + Pemetrexed is the first listed.
NCT00942825 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00942825 about?
NCT00942825 is a clinical study titled "Triplet Combination First Line Treatment in Non Small Cell Lung Cancer (NSCLC)". This is a randomized, open-label, multicenter, phase II study to compare a triplet combination of CBP501, pemetrexed and cisplatin with pemetrexed/cisplatin when administered to patients with locally advanced (stage IIIB with malignant pleural effusion or pericardial effusion) or metastatic (stage I...
What is the current status of trial NCT00942825?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 195 participants. The study started on 2009-04. Estimated completion is 2013-07.
What interventions are being tested in trial NCT00942825?
The interventions under investigation include: CBP501 + Cisplatin + Pemetrexed (DRUG), Cisplatin + Pemetrexed (DRUG).
Who is sponsoring clinical trial NCT00942825?
This trial is sponsored by CanBas Co., which has 5 total clinical trials registered on ClinicalTrials.gov.
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