Status:
COMPLETED
Safety and Anti-Disease Activity of CHR-2797 (Tosedostat) in Elderly and/or Treatment Refractory Patients With Acute Myeloid Leukemia (AML) and Multiple Myeloma (MM)
Lead Sponsor:
Chroma Therapeutics
Conditions:
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is an open-label, non-randomised, multi-centre phase I-II study of CHR-2797 administered orally once a day. The study involves two distinct phases: * Phase I: an open-label, dose-escalating phas...
Detailed Description
This is an open-label, non-randomised, multi-centre phase I-II study of CHR-2797 administered orally once a day. The study involves two distinct phases: Phase I: an open-label, dose-escalating phase ...
Eligibility Criteria
Inclusion
- Signed, informed consent.
- Patients with AML, MDS (subtype RAEB-1 or RAEB-2), or MM whose disease has relapsed or is refractory to front line and/ or salvage therapy; elderly patients (≥ 60 years) with AML, MDS, MM who are not candidates for chemotherapy and for whom other therapy is inappropriate.
- Patients should have recovered from the acute adverse effects of prior therapies (excluding alopecia and grade II neuropathy).
- AML, MDS and MM are diseases of the haematopoietic system and can cause myelosuppression. Consequently supportive therapy should be given to ensure adequate values, according to local guidelines.
- A bone marrow aspirate/ biopsy performed within four weeks prior to study entry.
- Adequate bone marrow, hepatic and renal function including the following:
- Patients with high blast counts can be included in the trial, if they can be controlled by the use of hydroxyurea (500-3000 mg daily).
- 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.
- Age ≥ 18 years
- 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 the start of the trial. A woman with reproductive potential is defined as one who is biologically capable of becoming pregnant. Patients who are not surgically sterile or postmenopausal must agree to use a medically acceptable and highly effective method of birth control for the duration of the study and to continue after the end of CHR-2797 treatment for a further 3 months (female patients) or for a further 6 months (for male patients and their partners). A highly effective method of birth control is defined as any method that results in a low failure rate, including implants, injectables, some intra-uterine devices (IUD's), sexual abstinence, and vasectomy/ sterilization. Sexually active males and females using oral contraceptive pills should also use barrier contraception. Although there is no reason to believe that the use of CHR-2797 has an effect on the pharmacokinetics of hormonal contraceptives, this has not yet been proven.
Exclusion
- Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 4 weeks prior to trial entry- except for hydroxyurea (maximum daily dose is 3 g).
- Indolent, smouldering myeloma, monoclonal gammopathy with unknown significance.
- Patients who need a daily dose of hydroxyurea greater than 3 g to control leukocytosis.
- Co-existing active infection or serious concurrent illness.
- 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.
- Patients with platelet count(s) \< 20,000.
- Patients who have had a blood transfusion (platelet support or packed cells) within 7 days prior to study entry.
- Persistent grade II or greater toxicity from any cause (except haematological toxicities and peripheral neuropathy).
- Patients with grade III-IV peripheral neuropathy.
- Pregnant or breast-feeding women.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00689000
Start Date
May 1 2006
End Date
December 1 2007
Last Update
October 22 2010
Active Locations (1)
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1
Nexus Oncology Ltd
Edinburgh, Scotland, United Kingdom, EH25 9PP