GFM-Acadesine: A Phase I-II Trial of Acadesine

Short name Acadesine

NCTNCT01813838Other id2012-003120-21

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Renal toxicity

Overview

Status: Terminated
Phase: Phase 1/2
Enrollment: 5 participants (actual)
Sponsor: Groupe Francophone des Myelodysplasies · Other
Design: Not randomized · Open label (no masking)
Countries: 1 country
France
Start: Jun 2013
Primary completion: Jun 2013
Completion: Jun 2015
First posted: 19 Mar 2013 (estimated)
Last update posted: 8 Nov 2016 (estimated)
Conditions: SMD

Timeline

1 trial · 1 stopped early

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2013201420152016

Ph 1/2
Acadesine
NCT01813838
Jun 2013 to Jun 2015
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

A phase I-II trial of Acadesine in IPSS high and int 2 myelodysplastic syndromes, acute myeloid leukemia with 20-30% marrow blasts and chronic myelomonocytic leukemia type 2 not responding to Azacitidine or Decitabine for at least 6 courses or relapsing after a response: Patients will receive 6 treatment cycles unless disease progression, transformation, or unacceptable toxicity occurs, or the patient refuses to continue participating in the study. Efficacy will be assessed at the end of the 2nd, 4th and 6th cycles. After 6 cycles, patients demonstrating a response (CR, PR, marrow CR, or HI) will be able to continue with cycles of Acadesine (at the same dose as in the preceding cycles, depending on their cohort) until progression.

Interventions

ACADESINE 140mg/kg/dDrug
ACADESINE 210mg/kg/dDrug
ACADESINE 315mg/kg/dDrug

Arms3

Experimental
ACADESINE 140mg/kg/d
3 patients will be included at the initial dose of Acadesine 140mg/kg/d
Experimental
ACADESINE 210mg/kg/d
In absence of toxicity at the dose of 140mg/kg/d. There is a dose escalation of acadesine at the dose of 210mg/kg/d for 3 additionnal patients
Experimental
ACADESINE 315mg/kg/d
In absence of toxicity at the dose of 210mg/kg/d. There is a dose escalation of acadesine at the dose of 315mg/kg/d for 3 additionnal patients

Primary outcomes1

Outcomes the sponsor listed as primary.

Determine the maximal tolerated dose (MTD)
Time frame · 6 month of treatment
Registry description
Phase I: Evaluation after 6 month of treatment. Responders will be treated until progression

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Myelodysplastic syndrome including the following WHO categories: refractory anemia with excess blasts (RAEB), non-proliferative chronic myelomonocytic leukemia (CMML) (leukocytes \< 13 G/L but \> 10% marrow blasts), WHO- AML with 20-30% marrow blasts (RAEB-T according to the FAB classification) * Prior treatment with Azacitidine or Decitabine for at least 6 courses without response (including CR, PR, marrow CR and stable disease with hematological improvement) or relapse after a response * IPSS score \>1 (IPSS: Int-2 or High); * Age ≥ 18 years; * Normal liver function tests, defined by total bilirubin and transaminases less than 1.5 time the upper limit of normal; * Normal renal function, defined by creatinine less than 1.5 time the upper limit of normal, creatinine clearance ≥ 50 mL/min. * Patient ineligible for allogeneic hematopoietic stem cell transplantation; * Written informed consent; * Patient must understand and voluntarily sign consent form; * Patient must be able to adhere to the visit schedule as outlined in the study and follow protocol requirements; * ECOG performance status between 0-2 at the time of screening; * Women of childbearing potential must: Agree to use effective contraception without interruption throughout the study and for a further 1 month after the end of treatment; * Men must: Agree to not conceive during the treatment and to use effective contraception during the treatment period (including periods of dose reduction or temporary suspension) and for a further 1 month after the end of treatment if their partner is of childbearing potential. Exclusion Criteria: * Severe infection or any other uncontrolled severe condition * Significant cardiac disease - NYHA Class III or IV or having suffered a myocardial infarction in the last 6 months * Less than 30 days since prior treatment with growth factors (EPO, G-CSF) * Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea. The patient must have recovered from all acute toxicities from any previous therapy. * Active cancer, or cancer during the year prior to trial entry other than basal cell carcinoma or carcinoma in situ of the cervix or breast; * Patient already enrolled in another therapeutic trial of an investigational drug; * HIV infection or active hepatitis B or C; * Women who are or could become pregnant or who are currently breastfeeding; * Any medical or psychiatric contraindication that would prevent the patient from understanding and signing the informed consent form; * Patient eligible for allotransplantation. * Known allergy to acadesine or any of its excipients * No affiliation to an insurance system

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