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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02200757
Recruitment Status : Unknown
Verified January 2016 by CytRx.
Recruitment status was:  Recruiting
First Posted : July 25, 2014
Last Update Posted : August 18, 2016
Information provided by (Responsible Party):

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
Metastatic Small Cell Lung Cancer Drug: Aldoxorubicin Drug: Topotecan Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : July 2017

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 Name: 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 Name: Hycamtin

Primary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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 identifier (NCT number): NCT02200757

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Sponsors and Collaborators
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Responsible Party: CytRx Identifier: NCT02200757    
Other Study ID Numbers: ALDOXORUBICIN-P2-SCLC-01
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: August 18, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents