## Protocol Section
### Identification Module
**NCT ID:** NCT00003979

**Brief Title:** CHS 828 in Treating Patients With Solid Tumors

**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

#### Organization Study ID Info
**ID:** EORTC-16985
#### Organization
**Class:** NETWORK
**Full Name:** European Organisation for Research and Treatment of Cancer - EORTC
#### Secondary ID Infos
**ID:** EORTC-16985
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-07-11

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-07-10

**Overall Status:** WITHDRAWN

#### Start Date
**Date:** 1999-04

**Status Verified Date:** 2012-07

#### Study First Post Date
**Date:** 2003-01-27
**Type:** ESTIMATED
**Study First Submit Date:** 1999-11-01
**Study First Submit QC Date:** 2003-01-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** NETWORK

**Name:** European Organisation for Research and Treatment of Cancer - EORTC

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief 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.

**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.

### Conditions Module

**Conditions:**

- Unspecified Adult Solid Tumor, Protocol Specific

**Keywords:**

- unspecified adult solid tumor, protocol specific

### Design Module

#### Design Info

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** CHS 828

**Type:** DRUG

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Innsbruck

**Country:** Austria

**Facility:** Innsbruck Universitaetsklinik

**Zip:** A-6020

**Location 2:**

**City:** Vienna

**Country:** Austria

**Facility:** Kaiser Franz Josef Hospital

**Zip:** A-1100

**Location 3:**

**City:** Brussels

**Country:** Belgium

**Facility:** Institut Jules Bordet

**Zip:** B-1000

**Location 4:**

**City:** Brussels

**Country:** Belgium

**Facility:** Ludwig Institute for Cancer Research

**Zip:** B-1200

**Location 5:**

**City:** Edegem

**Country:** Belgium

**Facility:** Universitair Ziekenhuis Antwerpen

**Zip:** B-2650

**Location 6:**

**City:** Leuven

**Country:** Belgium

**Facility:** U.Z. Gasthuisberg

**Zip:** B-3000

**Location 7:**

**City:** Copenhagen

**Country:** Denmark

**Facility:** Herlev Hospital - University Hospital of Copenhagen

**Zip:** DK-2730

**Location 8:**

**City:** Bordeaux

**Country:** France

**Facility:** Institut Bergonie

**Zip:** 33076

**Location 9:**

**City:** Clermont-Ferrand

**Country:** France

**Facility:** Centre Jean Perrin

**Zip:** 63011

**Location 10:**

**City:** Lyon

**Country:** France

**Facility:** Centre Leon Berard

**Zip:** 69373

**Location 11:**

**City:** Nantes-Saint Herblain

**Country:** France

**Facility:** CRLCC Nantes - Atlantique

**Zip:** 44805

**Location 12:**

**City:** Toulouse

**Country:** France

**Facility:** Institut Claudius Regaud

**Zip:** 31052

**Location 13:**

**City:** Villejuif

**Country:** France

**Facility:** Institut Gustave Roussy

**Zip:** F-94805

**Location 14:**

**City:** Essen

**Country:** Germany

**Facility:** Universitaetsklinik und Strahlenklinik - Essen

**Zip:** D-45122

**Location 15:**

**City:** Nuremberg

**Country:** Germany

**Facility:** Klinikum Nuernberg - Klinikum Nord

**Zip:** 90340

**Location 16:**

**City:** Amsterdam

**Country:** Netherlands

**Facility:** Vrije Universiteit Medisch Centrum

**Zip:** 1001HV

**Location 17:**

**City:** Amsterdam

**Country:** Netherlands

**Facility:** Antoni van Leeuwenhoekhuis

**Zip:** 1066 CX

**Location 18:**

**City:** Groningen

**Country:** Netherlands

**Facility:** Academisch Ziekenhuis Groningen

**Zip:** 9700 RB

**Location 19:**

**City:** Nijmegen

**Country:** Netherlands

**Facility:** University Medical Center Nijmegen

**Zip:** NL-6500 HB

**Location 20:**

**City:** Rotterdam

**Country:** Netherlands

**Facility:** Erasmus Medical Center

**Zip:** 3075 EA

**Location 21:**

**City:** Oslo

**Country:** Norway

**Facility:** Norwegian Radium Hospital

**Zip:** N-0310

**Location 22:**

**City:** Basel

**Country:** Switzerland

**Facility:** University Hospital

**Zip:** CH-4031

**Location 23:**

**City:** Bern

**Country:** Switzerland

**Facility:** Inselspital, Bern

**Zip:** CH-3010

**Location 24:**

**City:** St. Gallen

**Country:** Switzerland

**Facility:** Kantonsspital - St. Gallen

**Zip:** CH-9007

**Location 25:**

**City:** Newcastle Upon Tyne

**Country:** United Kingdom

**Facility:** Newcastle General Hospital

**State:** England

**Zip:** NE4 6BE

**Location 26:**

**City:** Dundee

**Country:** United Kingdom

**Facility:** Ninewells Hospital and Medical School

**State:** Scotland

**Zip:** DD1 9SY

**Location 27:**

**City:** Edinburgh

**Country:** United Kingdom

**Facility:** Western General Hospital

**State:** Scotland

**Zip:** EH4 2XU

**Location 28:**

**City:** Glasgow

**Country:** United Kingdom

**Facility:** C.R.C. Beatson Laboratories

**State:** Scotland

**Zip:** G61 1BD

#### Overall Officials

**Official 1:**

**Affiliation:** Cantonal Hospital of St. Gallen

**Name:** Thomas Cerny, MD

**Role:** STUDY_CHAIR

### References Module

#### References

**Citation:** 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.

**PMID:** 15763645

## Derived Section

### Condition Browse Module - Meshes

- ID: D000009369

- Term: Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
