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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT# 2006-002498-35 |
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The treatment of cancer often involves the use of more than one drug at the same time. In this study, patients are treated with the already marketed drug paclitaxel (administered every 3 weeks by infusion)and with the investigational drug CHR-2797 (given orally, once daily). The purpose of this study is to evaluate if it is safe to administer these two drugs together, and how well the combination is tolerated by patients. The first patients will receive a 90mg dose of CHR-2797; doses will be increased in subsequent patients, as long as they are adequately tolerated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Once daily oral administration of CHR-2797 ( escalating dose groups) in solid tumour patients receiving paclitaxel infusion every three weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHR-2797 | Drug | Oral once daily administration of capsules of CHR-2797, to determine safety and tolerability in patients being treated with paclitaxel infusion every 3 weeks for up to 18 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety, tolerability, dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of CHR-2797 when administered in combination with paclitaxel. | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetic profile of the combination of CHR-2797 and paclitaxel and identify any pharmacokinetic interaction between the 2 agents. | After 1st and 2nd infusion of paclitaxel | |
| To determine response and response duration, time to progressive disease or treatment failure during combination therapy and in those patients who continued beyond 18 weeks on monotherapy with CHR-2797. |
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Inclusion Criteria:
Exclusion Criteria:
Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 4 weeks prior to first dose of medication in this trial or within a longer period, depending on the defined characteristics of the agent e.g. 6 weeks for nitrosurea or mitomycin. Bisphosphonates for bone disease are permitted provided the doses are stable before and during the trial.
Co-existing active infection or serious concurrent illness.
Significant cardiovascular disease as defined by:
Any co-existing medical condition that in the investigator's judgement will
substantially increase the risk associated with the patient's participation in the study.
Psychiatric disorders or altered mental status precluding understanding of the
informed consent process and/or completion of the necessary studies.
Gastrointestinal disorders that may interfere with absorption of the study drug.
Persistent grade II or greater toxicity from any cause.
Patients with known brain tumours or metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound the evaluation of neurologic and other adverse events.
More than 4 prior chemotherapy regimens.
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| Name | Affiliation | Role |
|---|---|---|
| Carla van Herpen | UMC St Radboud | Principal Investigator |
| Ferry Eskens | Erasmus MC University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMC St Radboud | Nijmegen | 6525 GA | Netherlands | |||
| Erasmus MC University Medical Centre- Location Centrum |
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| Label | URL |
|---|---|
| British Journal of Cancer 103, 1362-1368 (26 October 2010) | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C531970 | tosedostat |
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| Maximum duration of patient treatment ( combination followed by monotherapy) was 9 months |
| Rotterdam |
| 3015 CE |
| Netherlands |