Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00003979
CHS 828 in Treating Patients With Solid Tumors
A Phase 1 study testing CHS 828 in people with Unspecified Adult Solid Tumor, Protocol Specific, run by European Organisation for Research and Treatment of Cancer - EORTC at 28 sites in 9 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of CHS 828 in treating patients who have solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- CHS 828
- How many people
- 0 participants
- Where
- 28 sitesin 9 countries
- Study dates
- Apr 1999to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed solid tumor not amenable to standard therapy
- No symptomatic brain or leptomeningeal involvement
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- WHO 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- WBC at least 4,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin less than 1.5 mg/dL
- Other liver function tests no greater than 2 times upper limit of normal (unless related to liver metastases)
Renal:
- Creatinine no greater than 1.4 mg/dL
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No active bacterial infection
- No other nonmalignant disease
- No alcoholism, drug addiction, or psychiatric disorders
- Able to take oral medication
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunotherapy
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas)
- No other concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since prior radiotherapy (6 weeks since extensive radiotherapy)
- No concurrent radiotherapy (except palliative radiotherapy)
Surgery:
- Not specified
Other:
- No other concurrent investigational drugs
- No other concurrent antitumor drugs
Trial locations and contacts
28 sites in 9 countries.
28 sites in 9 countries
France6 sites
Institut Bergonie
Bordeaux, 33076
Centre Jean Perrin
Clermont-Ferrand, 63011
Centre Leon Berard
Lyon, 69373
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, 44805
Institut Claudius Regaud
Toulouse, 31052
Institut Gustave Roussy
Villejuif, F-94805
Netherlands5 sites
Vrije Universiteit Medisch Centrum
Amsterdam, 1001HV
Antoni van Leeuwenhoekhuis
Amsterdam, 1066 CX
Academisch Ziekenhuis Groningen
Groningen, 9700 RB
University Medical Center Nijmegen
Nijmegen, NL-6500 HB
Erasmus Medical Center
Rotterdam, 3075 EA
Belgium4 sites
Institut Jules Bordet
Brussels, B-1000
Ludwig Institute for Cancer Research
Brussels, B-1200
Universitair Ziekenhuis Antwerpen
Edegem, B-2650
U.Z. Gasthuisberg
Leuven, B-3000
United Kingdom4 sites
Ninewells Hospital and Medical School
Dundee, Scotland, DD1 9SY
Western General Hospital
Edinburgh, Scotland, EH4 2XU
C.R.C. Beatson Laboratories
Glasgow, Scotland, G61 1BD
Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
Switzerland3 sites
University Hospital
Basel, CH-4031
Inselspital, Bern
Bern, CH-3010
Kantonsspital - St. Gallen
Sankt Gallen, CH-9007
Austria2 sites
Innsbruck Universitaetsklinik
Innsbruck, A-6020
Kaiser Franz Josef Hospital
Vienna, A-1100
Germany2 sites
Universitaetsklinik und Strahlenklinik - Essen
Essen, D-45122
Klinikum Nuernberg - Klinikum Nord
Nuremberg, 90340
Denmark1 site
Herlev Hospital - University Hospital of Copenhagen
Copenhagen, DK-2730
About this study
Official title: Phase I and Pharmacokinetics Study to Determine the Safety of CHS 828 in Patients With a Solid Tumor on a Single Oral Dose Repeated Every 3 Weeks
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of CHS 828 in treating patients who have solid tumors.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of oral CHS 828 in patients with solid tumors.
- Determine the qualitative and quantitative toxic effects of this regimen in these patients.
- Determine a safe dose of this regimen for phase II evaluation.
- Determine the pharmacokinetic profile of this regimen in these patients.
- Determine any antitumor activity in these patients.
OUTLINE: Patients receive oral CHS 828 every 3 weeks. Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of CHS 828 until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity.
Patients are followed for up to 4 weeks.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12 months.
- Being tested
- CHS 828
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHS 828Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startApr 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Thomas Cerny, MD, Study chair, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003979
- Sponsor's protocol ID
- EORTC-16985
- Other IDs
- EORTC-16985
- Status last verified
- Jul 2012
- First submitted
- 1 Nov 1999
- Last updated
- 11 Jul 2012
- Results posted
- No
Publications
Ravaud A, Cerny T, Terret C, Wanders J, Bui BN, Hess D, Droz JP, Fumoleau P, Twelves C. Phase I study and pharmacokinetic of CHS-828, a guanidino-containing compound, administered orally as a single dose every 3 weeks in solid tumours: an ECSG/EORTC study. Eur J Cancer. 2005 Mar;41(5):702-7. doi: 10.1016/j.ejca.2004.12.023.
PubMed 15763645
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I and Pharmacokinetics Study to Determine the Safety of CHS 828 in Patients With a Solid Tumor on a Single Oral Dose Repeated Every 3 Weeks
- ClinicalTrials.gov ID
- NCT00003979
- Acronym / sponsor ID
- EORTC-16985
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Apr 1999
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of CHS 828 in treating patients who have solid tumors.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of oral CHS 828 in patients with solid tumors.
- Determine the qualitative and quantitative toxic effects of this regimen in these patients.
- Determine a safe dose of this regimen for phase II evaluation.
- Determine the pharmacokinetic profile of this regimen in these patients.
- Determine any antitumor activity in these patients.
OUTLINE: Patients receive oral CHS 828 every 3 weeks. Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of CHS 828 until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity.
Patients are followed for up to 4 weeks.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHS 828 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2012.
- Results publication: PubMed 15763645Ravaud A, Cerny T, Terret C, Wanders J, Bui BN, Hess D, Droz JP, Fumoleau P, Twelves C. Phase I study and pharmacokinetic of CHS-828, a guanidino-containing compound, administered orally as a single dose every 3 weeks in solid tumours: an ECSG/EORTC study. Eur J Cancer. 2005 Mar;41(5):702-7. doi: 10.1016/j.ejca.2004.12.023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Cerny, MD study chair
Cantonal Hospital of St. Gallen
28 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CHS 828 in people with Unspecified Adult Solid Tumor, Protocol Specific, run by European Organisation for Research and Treatment of Cancer - EORTC at 28 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in France, Netherlands, Belgium, United Kingdom, Switzerland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003979, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2012.