Phase 1b Study to Investigate the Safety and Maximum Tolerated Dose of Aldoxorubicin (INNO-206) Plus Doxorubicin HCL in Subjects With Advanced Solid Tumors

Sponsor

ImmunityBio, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01673438

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

N/A

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 :

Jul 1, 2012

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Apr 1, 2014

Arms and Interventions

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 Names: INNO-206

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 Names:

INNO-206

Outcome Measures

Primary Outcome Measures

Safety and Tolerability [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

Tumor Response [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18 years, male or female.
Histologically or cytologically confirmed malignant solid tumor that has relapsed or is refractory to standard therapy or no standard chemotherapy exists.
Capable of providing informed consent and complying with trial procedures.
Baseline absolute left ventricular ejection fraction (LVEF) measured scintigraphically (MUGA, myocardial scintigram) or by ultrasound (echocardiogram) ≥ Institutional Lower Limit of Normal.
Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
Life expectancy > 12 weeks.
Measurable or evaluable disease according to RECIST 1.1 criteria.15
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 that ensures that the subject will be able to keep all study-related appointments.

Exclusion Criteria:

Palliative surgery, chemotherapy, immunotherapy and/or radiation treatment < 4 weeks prior to the Screening Visit.
Prior treatment with ≥ 150 mg/m2 doxorubicin HCl or Doxil® cumulative dose, or epirubicin ≥ 150 mg/m2.
Exposure to any investigational agent within 30 days of Randomization.
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).
History of other malignancies except cured basal cell carcinoma, squamous cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix.
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.

Clinically evident congestive heart failure (CHF) > class II of the New York Heart Association (NYHA) guidelines.
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.
Serious clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
History or signs of active coronary artery disease with or without angina pectoris.