COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Phase 1b Study to Investigate the Safety and Maximum Tolerated Dose of Aldoxorubicin (INNO-206) Plus Doxorubicin HCL 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: NCT01673438
Recruitment Status : Completed
First Posted : August 28, 2012
Last Update Posted : April 21, 2014
Information provided by (Responsible Party):

Brief Summary:
This is a phase 1b open-label study to investigate the safety and maximum tolerated dose of aldoxorubicin plus doxorubicin HCl adminstered as infusion every 3 weeks for up to 8 cycles in subjects with advance solid tumors.

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

Detailed Description:
An Open-Label Phase 1b Study to Investigate the Safety and Maximum Tolerated Dose of Aldoxorubicin (INNO-206) Plus Doxorubicin HCl Administered as Infusions Every 3 Weeks in Subjects with Advanced Solid Tumors

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Phase 1b Study to Investigate the Safety and Maximum Tolerated Dose of Aldoxorubicin (INNO-206) Plus Doxorubicin HCL Administered as Infusions Every 3 Weeks in Subjects With Advanced Solid Tumors
Study Start Date : July 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Aldoxorubicin plus doxorubicin
Aldoxorubicin dosages of 175, 240, and 320 (doxorubicin equivalents of 130, 180, and 240 mg/m2) will be administered as a 30 minutes IVI on Day 1 of each cycle. In addition 35 mg/m2 of doxorubicin HCl will be administered as an IVI over > 3 minutes no later than 3 hours, but no more than 6 hours before the start of aldoxorubicin infusion.
Drug: aldoxorubicin
Other Name: INNO-206

Primary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: up to 6 months ]
    The primary objective of this study is to determine the preliminary safety and maximum tolerated dose (MTD) of aldoxorubicin plus doxorubicin HCl in subjects with advanced solid tumors who have failed standard therapies.

Secondary Outcome Measures :
  1. Tumor Response [ Time Frame: up to 6 months ]
    The secondary objective of this study is to evaluate the tumor response to aldoxorubicin plus doxorubicin HCl in this population assessed by radiographic means using the RECIST 1.1 criteria.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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 or no standard chemotherapy exists.
  3. Capable of providing informed consent and complying with trial procedures.
  4. Baseline absolute left ventricular ejection fraction (LVEF) measured scintigraphically (MUGA, myocardial scintigram) or by ultrasound (echocardiogram) ≥ Institutional Lower Limit of Normal.
  5. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
  6. Life expectancy > 12 weeks.
  7. Measurable or evaluable disease according to RECIST 1.1 criteria.15
  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 that ensures that the subject will be able to keep all study-related appointments.

Exclusion Criteria:

  1. Palliative surgery, chemotherapy, immunotherapy and/or radiation treatment < 4 weeks prior to the Screening Visit.
  2. Prior treatment with ≥ 150 mg/m2 doxorubicin HCl or Doxil® cumulative dose, or epirubicin ≥ 150 mg/m2.
  3. Exposure to any investigational agent within 30 days of Randomization.
  4. Evidence of active or uncontrolled central nervous system (CNS) metastasis (negative imaging study performed due to suspicion of CNS metastasis within 4 weeks of Screening Visit).
  5. History of other malignancies except cured basal cell carcinoma, squamous cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix.
  6. Laboratory values: Screening serum creatinine ≥ 2 times the upper limit of normal (ULN), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the ULN if no liver metastases or 5 times the ULN if liver metastases, total bilirubin > 2 times the ULN, white blood cell (WBC) count < 3500/mm3, or absolute neutrophil count (ANC) < 1500/mm3, platelet concentration < 100,000/mm3, hematocrit level < 25% for females or < 27% for males, or coagulation tests (prothrombin time [PT]; partial thromboplastin time [PTT]), International Normalized Ration (INR) > 1.5 times the ULN, serum albumin < 2.0g/dL.
  7. Clinically evident congestive heart failure (CHF) > class II of the New York Heart Association (NYHA) guidelines.
  8. Baseline QTc > 470 msec and/or previous history of QT prolongation while taking other medications. Concomitant use of medications associated with a high incidence of QTc prolongation is not allowed.
  9. Serious clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
  10. History or signs of active coronary artery disease with or without angina pectoris.

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): NCT01673438

Layout table for location information
United States, California
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
Sponsors and Collaborators
Layout table for investigator information
Study Director: Dan Levitt, MD CytRx Coorporation

Layout table for additonal information
Responsible Party: CytRx Identifier: NCT01673438    
Other Study ID Numbers: ALDOXORUBICIN-P1-MTD-02
First Posted: August 28, 2012    Key Record Dates
Last Update Posted: April 21, 2014
Last Verified: April 2014
Keywords provided by CytRx:
solid tumor
phase 1
Additional relevant MeSH terms:
Layout table for MeSH terms
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action