Status:
COMPLETED
A Study of the Safety and Tolerability of the Addition of CHR-2797 to Paclitaxel in Patients With Advanced or Refractory Tumours
Lead Sponsor:
Chroma Therapeutics
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 infu...
Eligibility Criteria
Inclusion
- Signed, informed consent.
- Age \> 18 years
- Histologically or cytologically documented locally advanced or metastatic solid tumour refractory to standard therapy or for which no standard therapy exists.
- Patients should have recovered from the acute adverse effects of prior therapies (excluding alopecia).
- Adequate bone marrow, hepatic and renal function including the following:
- Hb \> 9g/dl (transfusion independent) or \>10g/dl (transfusion permitted), absolute neutrophil count \> 1.5 x 109/L, platelets ≥ 100 x 109/L;
- Total bilirubin ≤ 1.5 x upper normal limit;
- AST (SGOT), ALT (SGPT) ≤ 2.5 x upper normal limit
- Creatinine ≤1.5 x upper normal limit.
- Performance status (PS) ≤ 2 (ECOG scale).
- Estimated life-expectancy greater than 3 months.
- Female patients with reproductive potential must have a negative serum pregnancy test within 7 days prior to start of trial. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuation of treatment.
Exclusion
- 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:
- history of congestive heart failure requiring therapy;
- history of unstable angina pectoris or myocardial infarction up to 6 months prior to trial entry;
- presence of severe valvular heart disease;
- presence of a ventricular arrhythmia requiring treatment.
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00737555
Start Date
August 1 2006
End Date
March 1 2008
Last Update
February 15 2012
Active Locations (2)
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1
UMC St Radboud
Nijmegen, Netherlands, 6525 GA
2
Erasmus MC University Medical Centre- Location Centrum
Rotterdam, Netherlands, 3015 CE