A Phase I-II Study to Evaluate the Safety, Tolerability and Anti-Disease Activity of the Aminopeptidase Inhibitor, CHR-2797, in Elderly and/or Treatment Refractory Patients with Acute Myeloid Leukaemia or Multiple Myeloma

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 70

Inclusion Criteria

1.Signed, informed consent.
2.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*.
3.Patients should have recovered from the acute adverse effects of prior therapies (excluding alopecia and grade II neuropathy).
4.AML, MDS and MM are diseases of the haematopoetic and can cause myelosuppression; consequently supportive therapy should be given to ensure adequate values, according to local guidelines.
5.A bone marrow biopsy performed within four weeks prior to study entry.
6.Adequate bone marrow, hepatic and renal function including the following:
a.High blast counts are not an exclusion criteria and can be controlled by the use of hydroxyurea (500-3000 mg daily).
b.Total bilirubin = 1.5 x upper normal limit.
c.AST (SGOT), ALT (SGPT) = 2.5 x upper normal limit (or 5 x ULN in the presence of liver metastases).
d.Creatinine =1.5 x upper normal limit.
7.Age = 18 years
8.Performance status (PS) = 2 (ECOG scale).
9.Estimated life-expectancy greater than 3 months.
10.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. Acceptable methods of contraception include IUD, oral contraceptive, subdermal implant and double barrier (condom with a contraceptive sponge or contraceptive suppository).
* There will be a clinical conference after completion of phase I to decide on patient population for phase II: AML/MDS or MM or both.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.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).
2.Indolent, smouldering myeloma, monoclonal gammopathy with unknown
significance.
3.Patients who need a daily dose of hydroxyurea greater than 3 g to control leukocytosis.
4.Co-existing active infection or serious concurrent illness.
5.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.
6.Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies.
7.Gastrointestinal disorders that may interfere with absorption of the study drug.
8.Patients with platetlet count(s) < 20x10^9/L
9.Persistent grade II or greater toxicity from any cause (except haematological toxicities and peripheral neuropathy).
11.Patients with grade III–IV peripheral neuropathy.
12.Pregnant or breast-feeding women.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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