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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01706835
Recruitment Status : Completed
First Posted : October 15, 2012
Last Update Posted : December 17, 2014
Information provided by (Responsible Party):

Brief Summary:
This is a phase 1 open-label study to investigate the pharmacokinetics of aldoxorubicin administered as a 30 minute infustion every 3 weeks for up to 8 cycles in subjects with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: aldoxorubicin Phase 1

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: Aldoxorubicin
Aldoxorubicin dosages of 230 mg/m2 or 350 mg/m2 will be given as a 30 minute infusion every 3 weeks for 8 cycles.
Drug: aldoxorubicin
Other Name: INNO-206

Primary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: up to 3 months ]
    Blood samples will be obtained for pharmacokinetics. Standard pharmacokinetic parameters, including t1/2, Cmax, AUC, Vd and CL, will be determined.

Secondary Outcome Measures :
  1. Safety [ Time Frame: up to 6 months ]

    All subjects who receive any amount of aldoxorubicin will be included in the safety analyses, which will include the following:

    1. The incidence, severity, duration, causality, seriousness, and type of AEs and changes in the subject's physical examination, vital signs, and clinical laboratory results.
    2. Deaths and other SAEs will be tabulated.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 weeks.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01706835

United States, California
Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Study Director: Dan Levitt, MD CytRx Coorporation

Responsible Party: CytRx Identifier: NCT01706835     History of Changes
Other Study ID Numbers: ALDOXORUBICIN-P1-PK-01
First Posted: October 15, 2012    Key Record Dates
Last Update Posted: December 17, 2014
Last Verified: December 2014

Keywords provided by CytRx:
solid tumor
phase 1

Additional relevant MeSH terms:
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action