Status:
COMPLETED
A Phase I Clinical Study of Oral CP-4126 in Patients With Advanced Solid Tumour
Lead Sponsor:
Clavis Pharma
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
At step 1, patients with advanced solid tumors will receive CP-4126 capsules following a dose escalation schedule until the maximum tolerated dose is reached. At step 2, 20 patients will be randomized...
Detailed Description
This is a multicentre clinical study conducted in Belgium and in The Netherlands. The study is a phase I divided in 2 steps: The first step is a dose escalation to define the RD. At the second step th...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed solid tumour diagnosis
- Locally advanced or metastatic disease, for which there is no known effective treatment
- Performance Status 0 - 2 according to ECOG (Eastern Cooperative Oncology Group) Performance Status
- Age 18 years or more
- Life expectancy \> 3 months
- Adequate hematological and biological functions:
- Signed informed consent
Exclusion
- Symptomatic brain metastases
- Current peripheral neuropathy of grade \> 1 according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
- Radiotherapy
- to more than 30 % of bone marrow
- single dose up to 8 Gy
- less than one week prior to the study treatment
- of the upper GI tract
- Mucositis of the upper digestive tract, including stomatitis
- Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
- Previous anticancer therapy (chemotherapy, hormone therapy or immunotherapy) within 30 days prior to the first dose of oral CP-4126 \[6 weeks for mitomycin C and BCNU (= carmustine) and CCNU (=lomustine)\]
- Requirement of concomitant treatment with a non-permitted medication including alternative drugs and high doses of vitamins
- History of allergic reactions to gemcitabine
- Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection)
- Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance
- Pregnant or breast feeding women
- Absence of adequate contraception for both male and female fertile patients for the duration of the study; and also for six months after last treatment
- Known positive status for HIV and/or hepatitis B or C
- Any reason why, in the investigator's opinion, the patient should not participate
- Condition that impairs ability to swallow pills
- Coeliac disease or any other lipid malabsorption syndrome
- Drug and/or alcohol abuse
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00778128
Start Date
October 1 2008
End Date
April 1 2010
Last Update
September 6 2010
Active Locations (3)
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1
Institute Jules Bordet
Brussels, Belgium, 1000
2
The Netherlands Cancer Institute
Amsterdam, Netherlands
3
University Medical Centre Utrecht
Utrecht, Netherlands