Study to Investigate the Safety and Activity of Aldoxorubicin Plus Gemcitabine in Subjects With Metastatic Solid Tumors

NCT02235688 | Completed Phase 1

• 1 other identifier: ALDOXORUBICIN-P1-MTD-03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase 1 study to investigate the safety and activity of aldoxorubicin plus gemcitabine in Subjects with solid tumors.

Conditions

Metastatic Solid Tumors

Keywords

aldoxorubicin; INNO-206; solid tumors; gemcitabine; phase 1

Outcome Measures

Primary Outcomes (1)

• Safety Measures

  The primary objective of this study is to determine the preliminary safety of administration of aldoxorubicin in combination with gemcitabine in subjects with metastatic solid tumors as measured by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, vital signs, echocardiograms (ECHO) or multiple-gated acquisition (MUGA) scans, electrocardiogram (ECG) results, and weight.

  14 months

Secondary Outcomes (1)

• Tumor Response

  17 months

Study Arms (1)

aldoxorubicin

EXPERIMENTAL

Drug: aldoxorubicin; Drug: gemcitabine

Interventions

aldoxorubicin DRUG

administered at 170 mg/m2 by intravenous infusion (IVI) on Day 1 every 21 days plus 900 mg/m2 gemcitabine on Days 1 and 8 every 21 days.

Also known as: INNO-206

aldoxorubicin

gemcitabine DRUG

aldoxorubicin

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

Study Sites (2)

Virginia G. Piper Cancer Center

Scottsdale, Arizona, 85258, United States

Location

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

Location

MeSH Terms

Interventions

DOXO-EMCH; Gemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Dan Levitt, M.D.

  CytRx Coporation

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 15, 2014
• First Posted: September 10, 2014
• Study Start: August 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: February 10, 2022

Record last verified: 2017-06

Locations

US (2)