Status:
COMPLETED
Study to Investigate the Safety and Activity of Aldoxorubicin Plus Gemcitabine in Subjects With Metastatic Solid Tumors
Lead Sponsor:
ImmunityBio, Inc.
Conditions:
Metastatic Solid Tumors
Eligibility:
All Genders
15-80 years
Phase:
PHASE1
Brief Summary
This is a Phase 1 study to investigate the safety and activity of aldoxorubicin plus gemcitabine in Subjects with solid tumors.
Detailed Description
An open-label Phase 1b study to investigate the preliminary safety and activity of aldoxorubicin plus gemcitabine in subjects with metastatic solid tumors administered at doses of 170, 250 or 350 mg/m...
Eligibility Criteria
Inclusion
- Age between 15-80 years, male or female.
- Advanced, unresectable, metastatic solid tumor that has either relapsed or was refractory to treatment with at least 1 prior chemotherapy or immunotherapy regimen and for which no standard approved therapy exists.
- Progressive disease (PD) \< 6 months prior to enrollment.
- Capable of providing informed consent and complying with trial procedures.
- ECOG PS 0-2 (Appendix B).
- Life expectancy \>12 weeks.
- Measurable tumor lesions according to RECIST 1.1 criteria.
- Women must not be able to become pregnant (eg 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.)
- Males and their female partner(s) of child-bearing potential must use 2 forms of effective contraception (see Inclusion 8 plus condom or vasectomy for males) from the last menstrual period of the female partner during the study treatment and for 6 months after the final dose of study treatment.
- 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 the subject will be able to keep all study-related appointments.
Exclusion
- Prior exposure to \>5 cycles or 375 mg/m2 of either doxorubicin or Doxil®.
- Chemotherapy, palliative surgery and/or radiation treatment less than 30 days prior to enrollment.
- Exposure to any investigational agent within 30 days of enrollment.
- CNS metastases that are symptomatic.
- History of other malignancies except cured basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix unless documented free of cancer for ≥5 years.
- Laboratory values: Screening serum creatinine \>1.5×ULN, ALT \>3×ULN, or \>5×ULN if liver metastases are present, total bilirubin \>3×ULN, ANC \<1,500/mm3, platelet concentration \<100,000/mm3, hematocrit level \<25% for females or \<27% for males, coagulation tests (PT, PTT, INR) \>1.5×ULN, and albumin \<2.0 g/dL.
- Clinically evident CHF \> class II of the NYHA guidelines (Appendix D).
- Current serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V (Appendix F).
- 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 QT prolongation is not allowed (Appendix G).
- History or signs of active coronary artery disease with or without angina pectoris.
- Serious myocardial dysfunction defined scintigraphically (eg MUGA, myocardial scintigram) or ultrasound determined absolute LVEF \<45% of predicted.
- History of HIV infection.
- Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals.
- Major surgery within 21 days prior to enrollment.
- 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.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02235688
Start Date
August 1 2014
End Date
January 1 2017
Last Update
February 10 2022
Active Locations (2)
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1
Virginia G. Piper Cancer Center
Scottsdale, Arizona, United States, 85258
2
Sarcoma Oncology Center
Santa Monica, California, United States, 90403