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

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ClinicalTrials.gov Identifier: NCT02235688
Recruitment Status : Completed
First Posted : September 10, 2014
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
CytRx

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

Condition or disease Intervention/treatment Phase
Metastatic Solid Tumors Drug: aldoxorubicin Drug: gemcitabine Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Phase 1b Study to Investigate the Preliminary Safety and Activity of Aldoxorubicin Plus Gemcitabine in Subjects With Metastatic Solid Tumors
Study Start Date : August 2014
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: aldoxorubicin Drug: aldoxorubicin
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.
Other Name: INNO-206

Drug: aldoxorubicin
administered at 250 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.
Other Name: INNO-206

Drug: aldoxorubicin
administered at 350 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.
Other Name: INNO-206

Drug: gemcitabine



Primary Outcome Measures :
  1. Safety Measures [ Time Frame: 14 months ]
    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.


Secondary Outcome Measures :
  1. Tumor Response [ Time Frame: 17 months ]
    The secondary objective of this study is to evaluate the activity of aldoxorubicin in combination with gemcitabine in this population, assessed by overall response rate (ORR) and progression-free survival (PFS).



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 15-80 years, male or female.
  2. 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.
  3. Progressive disease (PD) < 6 months prior to enrollment.
  4. Capable of providing informed consent and complying with trial procedures.
  5. ECOG PS 0-2 (Appendix B).
  6. Life expectancy >12 weeks.
  7. Measurable tumor lesions according to RECIST 1.1 criteria.
  8. 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.)
  9. 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.
  10. Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
  11. Geographic accessibility to the site that ensures the subject will be able to keep all study-related appointments.

Exclusion Criteria:

  1. Prior exposure to >5 cycles or 375 mg/m2 of either doxorubicin or Doxil®.
  2. Chemotherapy, palliative surgery and/or radiation treatment less than 30 days prior to enrollment.
  3. Exposure to any investigational agent within 30 days of enrollment.
  4. CNS metastases that are symptomatic.
  5. 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.
  6. 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.
  7. Clinically evident CHF > class II of the NYHA guidelines (Appendix D).
  8. 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).
  9. 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).
  10. History or signs of active coronary artery disease with or without angina pectoris.
  11. Serious myocardial dysfunction defined scintigraphically (eg MUGA, myocardial scintigram) or ultrasound determined absolute LVEF <45% of predicted.
  12. History of HIV infection.
  13. Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals.
  14. Major surgery within 21 days prior to enrollment.
  15. Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.
  16. Any condition that is unstable and could jeopardize the subject's participation in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02235688


Locations
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United States, Arizona
Virginia G. Piper Cancer Center
Scottsdale, Arizona, United States, 85258
United States, California
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
Sponsors and Collaborators
CytRx
Investigators
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Study Director: Dan Levitt, M.D. CytRx Coporation
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Responsible Party: CytRx
ClinicalTrials.gov Identifier: NCT02235688    
Other Study ID Numbers: ALDOXORUBICIN-P1-MTD-03
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017
Keywords provided by CytRx:
aldoxorubicin
INNO-206
solid tumors
gemcitabine
phase 1
Additional relevant MeSH terms:
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Neoplasms
Gemcitabine
Doxorubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors