A Phase I Study to Assess the Safety, Pharmacokinetics, and Potential Effects of Amrubicin on the QT/QTc Interval in Cancer Patients With Advanced Solid Tumors.

Inclusion Criteria:

- Patients meeting all of the following criteria will be considered for enrollment into
the study:

1. Males or females, aged 18-65 years;

2. Histological or cytological diagnosis of solid malignancy for which no
acceptable standard therapy exists or for which approved standard therapy has
failed;

3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;

4. Life expectancy greater than 3 months;

5. Nonsmoker or not smoked or used tobacco products for at least 3 months before
the screening visit and agree to abstain from smoking/using tobacco products
throughout the formal study and until the End of Study visit;

6. Capable of giving informed consent, has signed the informed consent form, and is
willing to comply with scheduled visits, dose administration, and other study
procedures;

7. Women of childbearing potential may participate, providing they have a negative
serum pregnancy test (β-HCG) at screening, and a negative urine pregnancy test
prior to dosing on Day 1 of each cycle;

8. Males and females of childbearing potential must agree to the use of at least 2
effective contraceptive methods until at least 28 days following the last dose
of study drug;

9. Serum potassium, magnesium and corrected calcium that is within institutional
normal range at screening;

10. Adequate organ function including the following:

- Adequate bone marrow reserve: absolute neutrophil count (segmented and
bands) (ANC) ≥1.5 x 109/L, platelet count ≥100 x 109/L, and hemoglobin ≥90
g/L,

- Hepatic: bilirubin ≤1.5 x the upper limit of normal (ULN), ALT and AST ≤2.0
x ULN,

- Renal: serum creatinine ≤1.5 x ULN or calculated creatinine clearance >80
mL/min.

Exclusion Criteria:

- Patients meeting any of the following criteria will be excluded from the study:

1. Hypersensitivity to amrubicin or related compounds;

2. Radiotherapy with curative intent to a primary disease complex ≤ 28 days before
first dose; cranial radiotherapy ≤ 21 days before first dose; radiotherapy to
all other areas ≤ 7 days before first dose of amrubicin;

3. History or presence of clinically significant abnormal 12-lead ECG or triplicate
ECGs with a mean QT interval corrected for heart rate (HR) using Fridericia's
method (QTcF) of >450 msec (males) or >470 msec (females), a PR interval >240
msec or a QRS interval >110 msec (within 3 months of screening visit);

4. Left ventricular ejection fraction (LVEF) <50%;

5. Recent history (within 3 months of screening visit) of pericarditis and
pericardial effusion;

6. History within 6 months of the screening visit of one of the following:

- cardiac disease including congenital long-QT syndrome,

- angina, congestive heart failure,

- myocardial ischemia or infarction,

- myocarditis, chest pain or dyspnea on exertion of cardiac origin,,

- idiopathic or hypertrophic cardiomyopathy,

- sarcoidosis,

- syncope,

- epilepsy,

- or other clinically significant cardiac disease;

7. Family history of long QT syndrome;

8. Use of implantable pacemaker or implantable cardioverter defibrillator;

9. Clinically significant bradycardia (<50 beats per minute);

10. Systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg;

11. Previous treatment with an investigational agent or any anticancer therapy
within 4 weeks prior to the 'off-drug' visit;

12. Previous treatment with anticancer therapy and has not fully recovered (Common
Terminology Criteria Adverse Event [CTCAE] Grade 1, except alopecia) from the
toxic effects of that treatment;

13. Treatment with any medication known to produce QT prolongation enzyme-inducing
anticonvulsants, non-prescription medications including topical medications, all
vitamins, minerals, herbs or dietary supplements/remedies (e.g., Saint John's
Wort or Milk Thistle) for at least 7 days before the start of the off-drug
visit;

14. Previous treatment with any anthracycline;

15. Any condition that would put the patient at undue risk or discomfort as a result
of adherence to study procedures;

16. Women who are pregnant or nursing;

17. Uncontrolled intercurrent illness such as myelosuppression, renal impairment,
hepatic impairment, infection and uncontrolled diabetes;

18. Symptomatic central nervous system metastases. Patients with asymptomatic brain
metastases are allowed. The patient must be stable for ≥ 2 weeks after
radiotherapy, if the patient is on corticosteroids, the dose of corticosteroids
must have been stable for ≥ 2 weeks prior to the first dose of study treatment,
or be in the process of being tapered;

19. Suspected, diffuse idiopathic interstitial lung disease or pulmonary fibrosis
not related to prior treatment;

20. History of seropositive HIV or patients who are receiving immunosuppressive or
myelosuppressive medications that would, in the opinion of the investigator,
increase the risk of serious neutropenic complications;

21. Positive urine drug screen for undeclared concomitant medications and/or illegal
drug use at screening.