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

Tracking Information
First Submitted Date ICMJE	October 11, 2012
First Posted Date ICMJE	October 15, 2012
Last Update Posted Date	December 17, 2014
Study Start Date ICMJE	October 2012
Actual Primary Completion Date	December 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: October 12, 2012)	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.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01706835 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: October 12, 2012)	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: 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.
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	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
Official Title ICMJE	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
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.
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 ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Advanced Solid Tumors
Intervention ICMJE	Drug: aldoxorubicin; Other Name: INNO-206
Study Arms	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.; Intervention: Drug: aldoxorubicin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: December 15, 2014)	18
Original Estimated Enrollment ICMJE; (submitted: October 12, 2012)	12
Actual Study Completion Date	December 2014
Actual Primary Completion Date	December 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: 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. Exclusion Criteria: 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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01706835
Other Study ID Numbers ICMJE	ALDOXORUBICIN-P1-PK-01
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	CytRx
Study Sponsor ICMJE	CytRx
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Dan Levitt, MD CytRx Coorporation
PRS Account	CytRx
Verification Date	December 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP