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

NCT01706835 | Completed Phase 1

• 1 other identifier: ALDOXORUBICIN-P1-PK-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Keywords

solid tumor; aldoxorubicin; phase 1; pharmacokinetic; INNO-206

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics

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

  up to 3 months

Secondary Outcomes (1)

• Safety

  up to 6 months

Study Arms (1)

Aldoxorubicin

EXPERIMENTAL

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

Interventions

aldoxorubicin DRUG

Also known as: INNO-206

Aldoxorubicin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years, male or female.
• Histologically or cytologically confirmed malignant solid tumor that has relapsed or is refractory to standard therapy.
• 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.
• Capable of providing informed consent and complying with trial procedures.
• Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
• Life expectancy \>12 weeks.
• Measurable or evaluable disease.
• 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. \[Adequate contraception includes: oral contraception, implanted contraception, intrauterine device implanted for at least 3 months, or barrier method in conjunction with spermicide.\].
• Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
• Geographic accessibility to the site.

You may not qualify if:

• Palliative surgery, chemotherapy, immunotherapy and/or radiation treatment less than 4 weeks prior to the Screening Visit.
• Exposure to any investigational agent within 30 days of the Screening Visit.
• 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).
• Clinically evident congestive heart failure (CHF) \> class II of the New York Heart Association (NYHA) guidelines.
• Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
• Recent history (within 6 months) or current signs of active coronary artery disease with or without angina pectoris.
• Serious myocardial dysfunction defined scintigraphically (MUGA, myocardial scintigram) or ultrasound determined absolute left ventricular ejection fraction (LVEF) \<45% of predicted.
• Known history of HIV infection.
• Active, clinically significant serious infection requiring treatment with antibiotics, antivirals or antifungals.
• Major surgery within 4 weeks prior to treatment.
• Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.
• Any condition that is unstable and could jeopardize the subject's participation in the study.

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

Study Sites (1)

Samuel Oschin Comprehensive Cancer Institute

Los Angeles, California, 90048, United States

Location

MeSH Terms

Interventions

DOXO-EMCH

Study Officials

• Dan Levitt, MD

  CytRx Coorporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2012
• First Posted: October 15, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 10, 2022

Record last verified: 2014-12

Locations

US (1)