- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00737555
A Study of the Safety and Tolerability of the Addition of CHR-2797 to Paclitaxel in Patients With Advanced or Refractory Tumours
February 14, 2012 updated by: Chroma Therapeutics
A Phase 1b Dose-escalation Study to Evaluate the Safety and Tolerability of the Addition of the Aminopeptidase Inhibitor CHR-2797 to Paclitaxel in Patients With Advanced or Refractory Tumours
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nijmegen, Netherlands, 6525 GA
- UMC St Radboud
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Rotterdam, Netherlands, 3015 CE
- Erasmus MC University Medical Centre- Location Centrum
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 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:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Once daily oral administration of CHR-2797 ( escalating dose groups) in solid tumour patients receiving paclitaxel infusion every three weeks
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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.
Time Frame: 18 weeks
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18 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the pharmacokinetic profile of the combination of CHR-2797 and paclitaxel and identify any pharmacokinetic interaction between the 2 agents.
Time Frame: After 1st and 2nd infusion of paclitaxel
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After 1st and 2nd infusion of paclitaxel
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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.
Time Frame: Maximum duration of patient treatment ( combination followed by monotherapy) was 9 months
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Maximum duration of patient treatment ( combination followed by monotherapy) was 9 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Carla van Herpen, UMC St Radboud
- Principal Investigator: Ferry Eskens, Erasmus MC University Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
March 1, 2008
Study Registration Dates
First Submitted
August 18, 2008
First Submitted That Met QC Criteria
August 18, 2008
First Posted (Estimate)
August 19, 2008
Study Record Updates
Last Update Posted (Estimate)
February 15, 2012
Last Update Submitted That Met QC Criteria
February 14, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHR-2797-003
- EudraCT# 2006-002498-35
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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