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Effect of 14-day Repeated Oral Doses of SAR302503 on Ventricular Repolarization, Compared to 1-day Placebo in Adult Patients With Refractory Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Neoplasm Malignant

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Trial Information

Effect of 14-day Repeated Oral Doses of SAR302503 on Ventricular Repolarization, Compared to 1-day Placebo in Adult Patients With Refractory Solid Tumors

Total 7-10 weeks if not progressing to Segment 2. Segment 2 will be additional in 28-day

Inclusion Criteria

Inclusion criteria :

- Histologically or cytologically confirmed advanced solid malignancy that is metastatic
or unresectable, and for which standard curative measures do not exist

Exclusion criteria:

- Prior history of torsades de pointe, or congenital long QT syndrome.

- Conditions with screening ECG in which repolarization is difficult to interpret, or
showing significant abnormalities. This includes, but is not limited to: High degree
atrioventricular (AV) block, pacemaker, atrial fibrillation or flutter

- Screening ECG with QTc B or QTc F ≥480 msec (within 8 days of Day-1)

- Significant hypokalemia at screening (K+ <3.5 mmol/L) (within 8 days of Day-1)

- Significant hypomagnesemia at screening and inclusion (Mg++ <0.7 mmol/L) (within 8
days of Day -1)

- Patient receives (and cannot discontinue), or is scheduled to receive, a concomitant
treatment known to carry a risk of both QT prolongation and torsade de pointe for 2
weeks before Day 1 and for the duration of Segment 1

- Absence of completion of all prior chemotherapy, biological therapy, hormonal
therapy, targeted non-cytotoxic therapy ≥3 weeks; and radiotherapy ≥2 weeks prior to

- Patients with uncontrolled brain metastases or primary brain tumor. Patients with
brain metastasis are considered eligible if the patient has not received radiation
therapy for brain metastasis within 2 weeks of enrollment and has been on a stable
dose of steroids for ≥ 2 weeks.

- Participation in any study of an investigational agent (drug, biologic, device)
within 30 days prior to initiation of study drug, unless during non-treatment phase.

- Anticipation of need for a major surgical procedure or radiation therapy during the
study treatment.

- Concurrent treatment in another clinical trial or with any other cancer therapy
including chemotherapy, biological therapy, hormonal therapy, radiotherapy,
chemoembolization, cryotherapy, targeted non-cytotoxic therapy or patients planning
to receive these treatments during the study.

- Inadequate organ function as defined by:

- Absolute neutrophil count (ANC) <1.5 X 10^9/L

- Platelet count <100 X 10^9/L

- Hemoglobin: <9 g/dL

- Serum creatinine >1.5 x the upper limit of normal (ULN)

- Serum amylase or lipase >1.5 x ULN

- Total bilirubin >1.5 x ULN

- Aspartate aminotransferase or alanine aminotransferase ≥2.5 x ULN

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) >2 at study entry.

- Uncontrolled congestive heart failure (New York Heart Association Classification 3 or
4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral
artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within
3 months prior to initiation of study drug.

- Ongoing or recent history (within 3 months of Day 1 Segment 1) of clinically
significant dysrrhythmia.

- Patients taking a beta blocker within 7 days to Day 1 Segment 1 and during Segment 1

- Other concurrent serious illness or medical condition, including active infection or
HIV disease.

- Patients with known active (acute or chronic) Hepatitis A, B, C, and hepatitis B and
or C carriers. Prior history of chronic liver disease.

- Patients with history of partial or total gastrectomy, or, if in the opinion of the
investigator, have any other disorder that would inhibit absorption of oral

- Any severe acute or chronic medical, neurological, or psychiatric condition or
laboratory abnormality that may increase the risk associated with study participation
or study drug administration, may interfere with the informed consent process and/or
with compliance with the requirements of the study, or may interfere with
interpretation of study results and, in the Investigator's opinion, would make the
patient inappropriate for entry into this study.

- Contra-indications for palonosetron.

- Use of drugs or herbal agents known to be at least moderate inhibitors or inducers of
CYP3A4, sensitive CYP3A4 substrate, or CYP3A4 substrate with narrow therapeutic
index, within 2 weeks of Day 1 and during study.

- Concomitant treatment with H2-blockers is not allowed within 7 days prior to Day 1
Segment 1 and during entire study.

- Known hypersensitivity to any excipients in IMP formulations.

- Pregnant or lactating females

- Women of childbearing potential, unless using effective contraception (other than
oral contraceptives) while on study drug. Men who partner with a woman of
childbearing potential, unless they agree to use effective contraception while on
study drug

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

QTc Friderica (QTcF) parameter

Outcome Time Frame:

16 days

Safety Issue:


Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2013

Completion Date:

April 2014

Related Keywords:

  • Neoplasm Malignant
  • Neoplasms



Investigational Site Number 840003San Diego, California  92123
Investigational Site Number 840001St Louis, Missouri  63110
Investigational Site Number 840006San Antonio, Texas  78229
Investigational Site Number 840008San Antonio, Texas  78229