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
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: October 11, 2012
Last updated: August 12, 2013
Last verified: August 2013
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.
Advanced Solid Tumors
||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Pharmacokinetics [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
Blood samples will be obtained for pharmacokinetics. Standard pharmacokinetic parameters, including t1/2, Cmax, AUC, Vd and CL, will be determined.
Secondary Outcome Measures:
- Safety [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
All subjects who receive any amount of aldoxorubicin will be included in the safety analyses, which will include the following:
- The incidence, severity, duration, causality, seriousness, and type of AEs and changes in the subject's physical examination, vital signs, and clinical laboratory results.
- Deaths and other SAEs will be tabulated.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2013 (Final data collection date for primary outcome measure)
Aldoxorubicin dosages of 230 mg/m2 or 350 mg/m2 will be given as a 30 minute infusion every 3 weeks for 8 cycles.
Other Name: INNO-206
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706835
|Samuel Oschin Comprehensive Cancer Institute
|Los Angeles, California, United States, 90048 |
||Dan Levitt, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 11, 2012
||August 12, 2013
||United States: Food and Drug Administration
Keywords provided by CytRx:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 17, 2014