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Topotecan Liposomes Injection for Small Cell Lung Cancer (SCLC), Ovarian Cancer and Other Advanced Solid Tumors

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.
 
ClinicalTrials.gov Identifier: NCT00765973
Recruitment Status : Unknown
Verified October 2017 by Spectrum Pharmaceuticals, Inc.
Recruitment status was:  Active, not recruiting
First Posted : October 3, 2008
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc

Tracking Information
First Submitted Date  ICMJE October 1, 2008
First Posted Date  ICMJE October 3, 2008
Last Update Posted Date October 18, 2017
Study Start Date  ICMJE September 2008
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2008)
Evaluate the safety, tolerability and maximum tolerated dose of 2 different dosing schedules of TLI administered intravenously [ Time Frame: 21 days following initial dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2008)
Assess the pharmacokinetic profile of TLI [ Time Frame: 21 Day Cycle ]
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 Topotecan Liposomes Injection for Small Cell Lung Cancer (SCLC), Ovarian Cancer and Other Advanced Solid Tumors
Official Title  ICMJE A Phase 1 Study of Topotecan Liposomes Injection (TLI) in Subjects With Small Cell Lung Cancer (SCLC), Ovarian Cancer and Other Advanced Solid Tumors
Brief Summary

A multi-center, open-label, two-arm, dose-escalation study to establish the safety, tolerability, MTD, and schedule of TLI administered intravenously as a 30 minute infusion in adult subjects with advanced solid tumors that have relapsed, are refractory to standard therapy, or for whom there is no standard therapy available.

The two dosing regimens to be evaluated are:

  • Arm A: TLI dose on Days 1 and 8 of a 21-day treatment cycle (Starting dose: 1 mg/m2)
  • Arm B: TLI dose on Day 1 of a 21-day treatment cycle (Starting dose: 2 mg/m2)

When one of the two arms reaches MTD, all future subjects will then be enrolled in the remaining study arm until MTD of that arm is reached.

Detailed Description

The study will utilize an accelerated design with small initial cohort sizes that allow fewer subjects to be enrolled at sub-therapeutic doses such as the very low starting doses in both arms of the study. Initial cohorts will include only one subject and dose escalations will be in 100% increments until a single Grade 2 toxicity related to study drug or DLT occurs in Cycle 1. Dose escalation will proceed until the MTD is exceeded. MTD is defined as average of the highest dose level for which 2 out of 6 subjects experience a DLT and the previous dose level, provided no additional DLTs occur. Subjects who discontinue TLI treatment before completion of Cycle 1 for reasons other than toxicity will not be evaluable for the determination of MTD and will be replaced.

The study will consist of a screening period, treatment period, and a post-treatment period. Subjects will be followed for 30 days after their last TLI dose. Safety and tolerability parameters include clinical laboratory assessments, vital signs, physical examinations, and adverse events (AEs).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Small Cell Lung Cancer
  • Ovarian Cancer
  • Solid Tumors
Intervention  ICMJE
  • Drug: Topotecan Liposomes Injection (TLI)
    TLI dose on Days 1 and 8 of a 21-day treatment cycle (Starting dose: 1 mg/m2)
  • Drug: Topotecan Liposomes Injection (TLI)
    TLI dose on Day 1 of a 21-day treatment cycle (Starting dose: 2 mg/m2)
Study Arms  ICMJE
  • Experimental: A
    Arm A: TLI dose on Days 1 and 8 of a 21-day treatment cycle (Starting dose: 1 mg/m2)
    Intervention: Drug: Topotecan Liposomes Injection (TLI)
  • Experimental: B
    Arm B: TLI dose on Day 1 of a 21-day treatment cycle (Starting dose: 2 mg/m2)
    Intervention: Drug: Topotecan Liposomes Injection (TLI)
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: October 2, 2008)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Histologically or cytologically confirmed advanced solid tumor that has relapsed, is refractory to standard treatment, or for whom there is no standard therapy available.
  3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  4. Normal organ and marrow function as defined below within 14 days of study entry

    1. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    2. Platelet count ≥100 x 109/L
    3. Hemoglobin ≥ 9 g/dL
    4. Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
    5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN), or 5 x ULN for subjects with liver metastases
    6. Serum creatinine ≤ 1.5 x ULN or calculated estimated creatinine clearance ≥ 50 mL/min/1.73m2 for subjects with creatinine levels above institutional normal based on the Cockcroft and Gault formula.
  5. Never received prior TLI or topotecan HCl (Hycamtin®)
  6. At least 4 weeks must have elapsed from the last dose of chemotherapy.
  7. Life expectancy ≥ 3 months
  8. Women of childbearing potential must have a negative urine or blood pregnancy test within 7 days prior to initiation of treatment.
  9. If female, subject is post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (e.g., hormonal contraceptive, intra-uterine device (IUD), diaphragm with spermicide, condom with spermicide or abstinence) from the screening visit through the duration of study participation.
  10. If male, subject agrees to use an acceptable barrier method for contraception from the screening visit though the duration of study participation.
  11. Before enrollment, the subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign a written informed consent according to ICH/GCP, and national/local regulations.

Exclusion Criteria:

  1. Use of any investigational drugs, biologics, or devices within 28 days prior to study treatment or planned use during the course of the study.
  2. Primary tumors of central nervous system (CNS). Symptomatic brain metastases (unless subject is stable without requirement of steroids and/or antiseizure medications for at least three months) or leptomeningeal tumor involvement. Imaging studies are not required to rule this out unless there is a clinical suspicion of CNS disease.
  3. Prior chemotherapy or radiotherapy within 4 weeks of Day 1 of study (6 weeks for nitrosureas or mitomycin C).
  4. Planned concurrent systemic therapy (cytotoxic and/or cytostatic) and/or radiotherapy during study treatment.
  5. Less than 4 weeks have elapsed from the time of major surgery.
  6. Subjects with a history of allergic reactions or sensitivity attributed to compounds of similar chemical or biologic composition to TLI, including known allergies to the ingredients comprising the liposome (e.g., cholesterol and/or sphingomyelin), which in the Investigator's opinion may put the subject at risk for significant reaction to the study drug.
  7. Subjects who are pregnant or lactating.
  8. Subjects known to be positive for human immunodeficiency virus (HIV), hepatitis C antibody, or hepatitis B surface antigen.
  9. Prophylactic hematologic growth factors administered ≤ 2 weeks prior to start of treatment with TLI (excluding darbepoetin alfa and epoetin alfa).
  10. Active infection or any serious underlying medical condition, which would impair the ability of the subject to receive protocol treatment.
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00765973
Other Study ID Numbers  ICMJE HBS601
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Spectrum Pharmaceuticals, Inc
Study Sponsor  ICMJE Spectrum Pharmaceuticals, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Spectrum Pharmaceuticals, Inc
Verification Date October 2017

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