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Efficacy and Safety of Aldoxorubicin Compared to Topotecan in Subjects With Metastatic Small Cell Lung Cancer

Sponsor
CytRx (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02200757
Collaborator
(none)
132
Enrollment
37
Locations
2
Arms
34
Duration (Months)
3.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of aldoxorubicin compared to topotecan in subjects with metastatic small cell lung cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
132 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Topotecan in Subjects With Metastatic Small Cell Lung Cancer Who Either Relapsed or Were Refractory to Prior Chemotherapy
Study Start Date :
Sep 1, 2014
Anticipated Primary Completion Date :
Sep 1, 2016
Anticipated Study Completion Date :
Jul 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Aldoxorubicin

Drug: Aldoxorubicin
230 mg/m2 (170 mg/m2 doxorubicin equivalent) intravenously on Day 1 of each 21-day cycle. Number of cycles: until tumor progression or unacceptable toxicity occurs.
Other Names:
  • INNO-206

    		•
    Active Comparator: Topotecan

    Drug: Topotecan
    1.5 mg/m2/day intravenously for 5 consecutive days on Day 1 of each 21-day cycle OR 4 mg/m2 intravenously on Days 1, 8 and 15 of each 28-day cycle. Number of cycles: until tumor progression or unacceptable toxicity occurs
    Other Names:
  • Hycamtin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression-Free Survival (PFS) [24 months]

      PFS is defined as the time from the date of randomization to first documentation of objective tumor progression or to death due to any cause in the absence of previous documentation of objective tumor progression.

    Secondary Outcome Measures

    1. Overall Survival (OS) [36 months]

      Overall survival is defined as the time from randomization to date of death. In the absence of confirmation of death, survival time will be censored at the last date the subject is known to be alive.

    2. Safety Measures [24 months]

      The safety of aldoxorubicin compared to topotecan in this population assessed by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, vital signs, echocardiogram (ECHO) evaluations, electrocardiogram (ECG) results, and weight, as well as disease control rate and tumor response.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age ≥18 years male or female.

    2. Histological confirmation of SCLC.

    3. Relapsed or refractory to no more than 1 course of a systemic therapy regimen and is incurable by either surgery or radiation.

    4. Capable of providing informed consent and complying with trial procedures.

    5. ECOG PS 0-2.

    6. Life expectancy >8 weeks.

    7. Measurable tumor lesions according to RECIST 1.1 criteria.[22]

    8. 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.)

    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. Accessibility to the site that ensures the subject will be able to keep all study-related appointments.

    Exclusion Criteria:

    1. Prior exposure to >375 mg/m2 of doxorubicin or liposomal doxorubicin.

    2. Prior treatment with topotecan.

    3. Palliative surgery and/or radiation treatment < 21 days prior to date of randomization.

    4. Exposure to any investigational agent within 30 days of date of randomization.

    5. Exposure to any systemic chemotherapy within 21 days of date of randomization.

    6. Active (symptomatic) central nervous system (CNS) metastasis.

    7. History of other malignancies except cured basal cell carcinoma, cutaneous squamous cell carcinoma, melanoma in situ, superficial bladder cancer or carcinoma in situ of the cervix unless documented free of cancer for ≥3 years.

    8. Laboratory values: Screening serum creatinine >1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) >3×ULN or >5×ULN if liver metastases are present, total bilirubin >2×ULN, absolute neutrophil count (ANC) <1,500/mm3, platelet concentration <100,000/mm3, hemoglobin <9 g/dL, albumin <2 gm/dL.

    9. Anion gap > 16 meq/L or arterial blood pH < 7.30.

    10. Clinically evident congestive heart failure (CHF) > class II of the New York Heart Association (NYHA) guidelines (Appendix D).

    11. 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).

    12. Baseline QTc >470 msec measured by Fridericia's formula (QTcF) 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.

    13. History or signs of active coronary artery disease with angina pectoris within the last 6 months.

    14. Serious myocardial dysfunction defined by ECHO as absolute left ventricular ejection fraction (LVEF) below the institution's lower limit of predicted normal.

    15. Known history of HIV infection.

    16. Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals.

    17. Treatment with p-glycoprotein inhibitors such as cyclosporine A, elacridar, ketoconazole, ritonavir, saquinavir.

    18. Major surgery within 30 days prior to date of randomization.

    19. Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.

    20. Any condition that is unstable and could jeopardize the subject's participation in the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cedars-Sinai Medical Center Los Angeles California United States 90048
    2 City of Hope Medical Group Pasadena California United States 91030
    3 University of Colorado Cancer Center Aurora Colorado United States 80045
    4 Lynn Cancer Institute Boca Raton Florida United States 33486
    5 Cancer Specialists of North Florida-Fleming Island Fleming Island Florida United States
    6 Hematoloy Oncology Associates Port St. Lucie Florida United States 34982
    7 Northwest Georgia Oncology Centers, P.C. Marietta Georgia United States 30060
    8 James Graham Brown Cancer Center Louisville Kentucky United States 40202
    9 West Jefferson Medical Center, Cancer Center Marrero Louisiana United States 70072
    10 Bay Hematology Oncology Easton Maryland United States 21601
    11 Washington University School of Medicine, Department of Internal Medicine St. Louis Missouri United States 63110
    12 Montefiore Medical Center Bronx New York United States 10467
    13 Oncology Hermatology Care, Inc. Cincinnati Ohio United States 45242
    14 Northwest CCOP Kaiser Permanente Portland Oregon United States 97227
    15 Penn State Hershey Cancer Institute Hershey Pennsylvania United States 17033
    16 Tennessee Oncology Cattanooga Tennessee United States 37404
    17 Tennessee Cancer Specialists Knoxville Tennessee United States 37909
    18 Sarah Cannon Research Institute Nashville Tennessee United States 37203
    19 Sarah Cannon Research Institute Nashville Tennessee United States 37203
    20 Koranyi National Institute of TBC and Pulmonologyhhy Budapest Hungary
    21 Koranyi National Institute of TBC and Pulmonology Budapest Hungary
    22 University of Debrecen, Medical and Health Science Center, Department of Pulmonology Debrecen Hungary
    23 Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital, Department of Pulmonology Nyiregyhaza Hungary
    24 Medical Center of the University of Pecs, 1st Department of Internal Medicine Pecs Hungary
    25 Hetenyi Geza Hospital Szolnok, Jasz-Nagykun-Szolnok Hungary
    26 Hospital General Universitario de Alicante Alicante Spain
    27 Hospital Clinic i Provincial de Barcelona Barcelona Spain
    28 Hospital Universitario Quiron-Dexeus (IOR) Barcelona Spain
    29 University Hospital Vall d'Hebron Barcelona Spain
    30 Hospital Universitario Lucus Augusti Lugo Spain
    31 General University Hospital Gregorio Maranon Madrid Spain
    32 Hospital Puerta de Hierro Madrid Spain
    33 University Hospital Foundation Jimenez Diaz Madrid Spain
    34 University Hospital La Paz Madrid Spain
    35 Hospital Regional Universitario Malaga Spain
    36 University Hospital Virgen de Valme Sevilla Spain
    37 CHU Xeral Vigo Spain

    Sponsors and Collaborators

    • CytRx

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CytRx
    ClinicalTrials.gov Identifier:
    NCT02200757
    Other Study ID Numbers:
    • ALDOXORUBICIN-P2-SCLC-01
    First Posted:
    Jul 25, 2014
    Last Update Posted:
    Aug 18, 2016
    Last Verified:
    Jan 1, 2016
    Additional relevant MeSH terms:
    Lung Neoplasms
    Small Cell Lung Carcinoma
    Topotecan

    Study Results

    No Results Posted as of Aug 18, 2016