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Trial record 11 of 24 for:    inno-206

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

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
CytRx

Tracking Information
First Submitted Date  ICMJE July 23, 2014
First Posted Date  ICMJE July 25, 2014
Last Update Posted Date August 18, 2016
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2014)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Aldoxorubicin Compared to Topotecan in Subjects With Metastatic Small Cell Lung Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Small Cell Lung Cancer
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Aldoxorubicin
    Intervention: Drug: Aldoxorubicin
  • Active Comparator: Topotecan
    Intervention: Drug: Topotecan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 24, 2014)
132
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2017
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02200757
Other Study ID Numbers  ICMJE ALDOXORUBICIN-P2-SCLC-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CytRx
Study Sponsor  ICMJE CytRx
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CytRx
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP