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A Dose Escalation Safety and Pharmacokinetic Study of SAR103168 Administered as a Single Agent by Intravenous Infusion, Once Daily for 5 Consecutive Days to Patients With Refractory/ Relapsed Acute Leukemias or High-risk Myelodysplastic Syndromes.


Phase 1
18 Years
N/A
Not Enrolling
Both
Acute Myelogenous Leukemia

Thank you

Trial Information

A Dose Escalation Safety and Pharmacokinetic Study of SAR103168 Administered as a Single Agent by Intravenous Infusion, Once Daily for 5 Consecutive Days to Patients With Refractory/ Relapsed Acute Leukemias or High-risk Myelodysplastic Syndromes.


Patients will receive the study drug until unacceptable toxicity, clinically significant
disease progression, withdrawal of consent or investigator's decision, and for a maximum of
1 year.


Inclusion Criteria:



- Patients with refractory/relapsed acute leukemias or high-risk myelodysplastic
syndromes with no curative option available including any of the following:

- Patients with de novo or secondary acute myelogenous leukemia (AML) (except
acute promyelocytic leukemia), meeting one of the following conditions:

- Refractory or relapsed AML; In case of first relapse the CR duration should be
less than 12 months. If the relapse failed at least one prior salvage attempt,
the CR duration may be more than 12 months.

- Into the expanded cohort at the MTD, previously untreated AML patients over age
60 with poor- risk cytogenetics who are not eligible for or do not accept
induction chemotherapy may also be included.

- Patients with refractory/relapsed acute lymphoblastic leukemia (ALL)

- Patients with high-risk myelodysplastic syndrome (MDS) as defined by the
International Prognostic Scoring System

- Patients with chronic myeloid leukemia in blast phase (CML-BP)

Exclusion Criteria:

- performance status > 2

- Active uncontrolled central nervous system leukemia

- Cytotoxic therapy within 2 weeks prior to the first dose of SAR103168. For the non
cytotoxic agents/investigational drugs this washout period should be at least 2 weeks
or at least 5 half-lives whichever is longer. Hydroxyurea must be stopped at least 24
hours prior to the first dose of SAR103168

- Lack of recovery from toxicities from prior therapies to grade < 1

- White blood cells > 30 x 10^9/L prior to the first dose of SAR103168

- Prior allogeneic stem cell transplantation or donor lymphocytes infusion within 3
months preceding the first dose of SAR103168

- Any of the following within 6 months prior to the first dose of SAR103168:

- Myocardial infarction, congestive heart failure, documented angina pectoris,
arrhythmia requiring medication (in particular atrial fibrillation or flutter),
severe conduction disorder (second or third atrio-ventricular block, pacemaker),
coronary/peripheral artery bypass graft surgery

- Arterial or venous thromboembolism, deep venous thrombosis

- Left ventricular ejection fraction < 50% by echocardiography or multiple gated
acquisition scan

- Cardiac ischemia on 12-lead ECG

- Baseline QTc-interval > 500 msec

- Hypertension uncontrolled with appropriate therapy

- Active infection (viral, bacterial or fungal) uncontrolled with appropriate therapy

- Major surgery within 6 weeks prior to the first dose of SAR103168

- Poor organ function defined by one of the following:

- Total bilirubin > 1.5 x upper limit of normal (ULN) unless related to leukemia
(i.e. hemolysis) or Gilbert's syndrome

- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 2.5 x ULN

- Serum creatinine > 1.5 x ULN or calculated creatinine clearance < 50 mL/min

- Patients under treatment with potent inhibitors of CYP3A4 unless these treatments may
be stopped at least 3 days prior to the first dose of SAR103168

- Patients under treatment with CYP3A4 or CYP2C9 inducers, unless these treatments may
be stopped at least 3 days prior to the first dose of SAR103168

- Pregnant or breast-feeding women or refusal to use adequate contraceptive method,
when applicable.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of DLTs during the initial 4-week period of treatment

Outcome Time Frame:

4 weeks

Safety Issue:

Yes

Principal Investigator

Farhad Ravandi-Kashani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center, Houston, Texas

Authority:

United States: Food and Drug Administration

Study ID:

TED10416

NCT ID:

NCT00981240

Start Date:

September 2009

Completion Date:

February 2012

Related Keywords:

  • Acute Myelogenous Leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Sanofi-Aventis Investigational Site Number 840003Atlanta, Georgia  30322
Sanofi-Aventis Investigational Site Number 840002New York, New York  10021
Sanofi-Aventis Investigational Site Number 840001Houston, Texas  77030