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An Open-Lable Phase 1 Study to Investigate the Pharmacolkinetics of Aldoxorubicin (INNO-206;DOXO-EMCH) Administered as a 30 Minute Infusion Every 3 Weeks in Subjects With Advanced Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Advanced Solid Tumors

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Trial Information

An Open-Lable Phase 1 Study to Investigate the Pharmacolkinetics of Aldoxorubicin (INNO-206;DOXO-EMCH) Administered as a 30 Minute Infusion Every 3 Weeks in Subjects With Advanced Solid Tumors

An Open-Label Phase 1 Study to Investigate the Pharmacokinetics of Aldoxorubicin
Administered as a 30 Minute Infusion Every 3 Weeks in Subjects with Advanced Solid Tumors.

Inclusion Criteria:

1. Age ≥18 years, male or female.

2. Histologically or cytologically confirmed malignant solid tumor that has relapsed or
is refractory to standard therapy.

3. Subjects who have received prior radiation therapy with stable central nervous system
(CNS) metastasis with no progression of brain metastasis by CT/MRI scan in last 4

4. Capable of providing informed consent and complying with trial procedures.

5. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.

6. Life expectancy >12 weeks.

7. Measurable or evaluable disease.

8. Women must not be able to become pregnant (e.g. post-menopausal for at least 1 year,
surgically sterile, or practicing adequate birth control methods) for the duration of
the study. [Adequate contraception includes: oral contraception, implanted
contraception, intrauterine device implanted for at least 3 months, or barrier method
in conjunction with spermicide.].

9. Women of child bearing potential must have a negative serum or urine pregnancy test
at the Screening Visit and be non-lactating.

10. Geographic accessibility to the site.

Exclusion Criteria:

1. Palliative surgery, chemotherapy, immunotherapy and/or radiation treatment less than
4 weeks prior to the Screening Visit.

2. Exposure to any investigational agent within 30 days of the Screening Visit.

3. Laboratory values: Screening serum creatinine greater than or equal to 1.5 mg/dL,
alanine aminotransferase (ALT) greater than 3 times the upper limit of normal (ULN)
or 5 times the ULN in liver metastases, total bilirubin greater than 3 times the ULN,
white blood cell (WBC) count <3500/mm3, absolute neutrophil (ANC) count < 2000/mm3,
platelet concentration <100,000/mm3, hematocrit level <25% for females or <28% for
males (transfusion is allowed during screening).

4. Clinically evident congestive heart failure (CHF) > class II of the New York Heart
Association (NYHA) guidelines.

5. Serious, clinically significant cardiac arrhythmias, defined as the existence of an
absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.

6. Recent history (within 6 months) or current signs of active coronary artery disease
with or without angina pectoris.

7. Serious myocardial dysfunction defined scintigraphically (MUGA, myocardial
scintigram) or ultrasound determined absolute left ventricular ejection fraction
(LVEF) <45% of predicted.

8. Known history of HIV infection.

9. Active, clinically significant serious infection requiring treatment with
antibiotics, antivirals or antifungals.

10. Major surgery within 4 weeks prior to treatment.

11. Substance abuse or any condition that might interfere with the subject's
participation in the study or in the evaluation of the study results.

12. Any condition that is unstable and could jeopardize the subject's participation in
the study.

Type of Study:


Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

Blood samples will be obtained for pharmacokinetics. Standard pharmacokinetic parameters, including t1/2, Cmax, AUC, Vd and CL, will be determined.

Outcome Time Frame:

up to 3 months

Safety Issue:


Principal Investigator

Dan Levitt, MD

Investigator Role:

Study Director

Investigator Affiliation:

CytRx Coorporation


United States: Food and Drug Administration

Study ID:




Start Date:

October 2012

Completion Date:

August 2013

Related Keywords:

  • Advanced Solid Tumors
  • solid tumor
  • aldoxorubicin
  • phase 1
  • pharmacokinetic
  • INNO-206
  • Neoplasms



Samuel Oschin Comprehensive Cancer Institute Los Angeles, California  90048