Bioequivalence Study of IG-001 Versus Abraxane in Metastatic or Locally Recurrent Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by IgDraSol, Inc.
Sponsor:
Collaborator:
Vector Oncology
Information provided by (Responsible Party):
IgDraSol, Inc.
ClinicalTrials.gov Identifier:
NCT02064829
First received: February 14, 2014
Last updated: June 10, 2014
Last verified: June 2014

February 14, 2014
June 10, 2014
March 2014
April 2015   (final data collection date for primary outcome measure)
  • Maximum observed concentration of paclitaxel (Cmax) [ Time Frame: Periods 1 and 2 - Predose; During infusion: 15 min and 30 min; Post-infusion: 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 4 hr, 6 hr, 8 hr, 24 hr, 48 hr, 72 hr ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve from time zero to infinite time of paclitaxel (AUC 0-inf) [ Time Frame: Periods 1 and 2 - Predose; During infusion: 15 min and 30 min; Post-infusion: 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 4 hr, 6 hr, 8 hr, 24 hr, 48 hr, 72 hr ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve from time zero to time t of paclitaxel (AUC 0-t) [ Time Frame: Periods 1 and 2 - Predose; During infusion: 15 min and 30 min; Post-infusion: 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 4 hr, 6 hr, 8 hr, 24 hr, 48 hr, 72 hr ] [ Designated as safety issue: No ]
Maximum observed concentration of paclitaxel (Cmax) [ Time Frame: Periods 1 and 2 - Predose; During infusion: 15 min and 30 min; Post-infusion: 15 min, 30 min, 1 h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT02064829 on ClinicalTrials.gov Archive Site
Number of participants affected by treatment-emergent adverse events coded using the Medical Dictionary for Regulatory Activities (MedDRA) [ Time Frame: Up to 30 days after the last dose of study drug ] [ Designated as safety issue: Yes ]
  • Area under the concentration-time curve from time zero to time t of paclitaxel (AUC 0-t) [ Time Frame: Periods 1 and 2 - Predose; During infusion: 15 min and 30 min; Post-infusion: 15 min, 30 min, 1 h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve from time zero to infinite time of paclitaxel (AUC 0-inf) [ Time Frame: Periods 1 and 2 - Predose; During infusion: 15 min and 30 min; Post-infusion: 15 min, 30 min, 1 h, 1.5 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h ] [ Designated as safety issue: No ]
  • Number of participants affected by treatment-emergent adverse events coded using the Medical Dictionary for Regulatory Activities (MedDRA) [ Time Frame: Up to 30 days after the last dose of study drug ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Bioequivalence Study of IG-001 Versus Abraxane in Metastatic or Locally Recurrent Breast Cancer
An Open-label, Randomized, Multi-center, Single-Dose, 2-Sequence, 2-Period, Crossover, Comparative Bioequivalence Study of IG-001 260 mg/m2 Versus Abraxane® 260 mg/m2 Administered Intravenously in Patients With Metastatic or Locally Recurrent Breast Cancer

The purpose of this study is to demonstrate bioequivalence of IG-001 versus Abraxane in female patients with metastatic or locally recurrent breast cancer. In addition, the study will compare the safety and tolerance of IG-001 and Abraxane during the bioequivalence 2-period crossover portion of the study. The study will also evaluate the long-term safety of IG-001 over repeated cycles, up to 4 additional cycles of administration.

This study is designed to compare the pharmacokinetics (PK) of IG-001 and Abraxane in patients with metastatic or locally recurrent breast cancer. Patients meeting the eligibility criteria will be randomized to determine which drug is administered first.

  • Patients randomized to Group 1 will receive a single dose of IG-001 (Period 1) followed 3 weeks later by a single dose of Abraxane (Period 2).
  • Patients randomized to Group 2 will receive a single dose of Abraxane (Period 1) followed 3 weeks later by a single dose of IG-001 (Period 2).

Blood samples for PK analysis will be taken at specified times before, during, and after the infusion of each drug in Periods 1 and 2. Following successful completion of Period 1 and Period 2, patients may be eligible for up to 4 additional cycles of treatment with IG-001 in the extension study.

Safety will be monitored throughout the study.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Metastatic Breast Cancer
  • Locally Recurrent Breast Cancer
  • Drug: Abraxane
    260 mg/m2 administered intravenously over 30 minutes on Day 1 every 3 weeks
    Other Names:
    • Paclitaxel albumin-bound particles for injectable suspension
    • nab-paclitaxel
  • Drug: IG-001
    260 mg/m2 administered intravenously over 30 minutes on Day 1 every 3 weeks
    Other Names:
    • Paclitaxel polymeric micelles for injectable suspension
    • Genexol-PM
    • Cynviloq
  • Active Comparator: Reference Drug - Abraxane
    260 mg/m2 administered intravenously over 30 minutes on Day 1
    Intervention: Drug: Abraxane
  • Experimental: Test Drug - IG-001
    260 mg/m2 administered intravenously over 30 minutes on Day 1
    Intervention: Drug: IG-001
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
June 2015
April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Breast cancer patient who

    1. Has histologically confirmed diagnosis of breast cancer.
    2. Has stage IV or locally recurrent breast cancer per the American Joint Committee on Cancer Staging Manual (7th edition).
    3. Has failed any single agent or combination chemotherapy for metastatic or locally recurrent disease. Prior therapy should have included an anthracycline unless clinically contraindicated.
    4. Has agreed to participate in the study and signed the informed consent form prior to participation in any study activities.
  2. Sex and Age: Female > or = 30 years of age.
  3. Body surface area (BSA) that is within 1.5 to 2.2 m2, calculated using the Mosteller or DuBois Formula.
  4. Eastern Cooperative Oncology Group (ECOG) performance status < or = 1.
  5. Sitting blood pressure (BP): systolic BP between 90-160 mmHg, inclusive, and diastolic BP between 50-100 mmHg, inclusive, and radial pulse rate: 50-100 beats per minute, inclusive.
  6. Hematology/chemistry: adequate hematological, renal, and hepatic function within 7 days prior to randomization.
  7. All other clinical laboratory values deemed normal or not clinically significant by the Principal Investigator/Sub-Investigator.
  8. Patients must be non-pregnant.
  9. Patients must be non-lactating.
  10. If sexually active, women of childbearing potential must agree to use contraception considered adequate and appropriate by the Investigator (hormonal or barrier method, abstinence) throughout the study and for 30 days after the last dose of study drug.
  11. Able and willing to adhere to all protocol requirements and study procedures throughout the study.
  12. Ability to comprehend and be informed of the nature of the study, as assessed by study clinic staff.

Exclusion Criteria:

  1. Patients with a history of other malignancies, except for adequately treated non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or breast, or other solid tumors curatively treated with no evidence of disease for > or = 5 years.
  2. Patients who have previously received Abraxane or IG-001.
  3. Patients who received a taxane within the last 6 months prior to randomization.
  4. Patients who have not completely recovered from any toxicities from previous chemotherapy, hormone therapy, immunotherapy, or radiotherapy > or = Grade 1 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, with the exception of alopecia.
  5. Prior chemotherapy must be completed at least 30 days pror to randomization (42 days for mitomycin C or nitrosoureas). Prior immunotherapy, prior anti-tumor hormonal therapy, and prior radiotherapy must be completed at least 14 days prior to randomization. Radiotherapy is not allowed during the study. Administration of other chemotherapy, immunotherapy, or anti-tumor hormonal therapy during the study is not allowed.
  6. Patient had major surgery within 30 days prior to randomization, or patient has not recovered from prior major surgery.
  7. Sensory / Peripheral neuropathy of > Grade 1 per NCI CTCAE version 4.0 at Screening.
  8. Patients with known brain metastases, with the exception of patients who have completed surgery and/or radiotherapy at least 3 months prior to randomization, have completed any steroids at least 3 months prior to randomization, and are currently asymptomatic.
  9. Known history or presence of any clinically significant disease or condition other than cancer unless determined as not clinically significant by the Principal Investigator/Sub-Investigator.
  10. History of difficulty with donating blood or difficulty in accessibility of central line.
  11. Known history or presence of:

    1. HIV, Hepatitis B, or Hepatitis C
    2. Alcohol abuse or dependence within one year prior to randomization
    3. Drug abuse or dependence within one year prior to randomization (marijuana, amphetamines, barbiturates, cocaine, opiates and benzodiazepines)
    4. Hypersensitivity or idiosyncratic reaction to paclitaxel, its excipients, and/or related substances, including, albumin and PEG
    5. Severe allergic reactions (e.g., anaphylactic reactions, angioedema)
  12. Patients may not participate in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or the use of investigational devices with therapeutic intent within 30 days prior to randomization and while enrolled in this study.
  13. Use of any strong inhibitors of cytochrome P450 (CYP) enzymes (e.g., fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (e.g., barbiturates (phenobarbital), carbamazepine, phenytoin and rifampin), in the previous 14 days before randomization until the last blood draw in the final study period.
  14. Acute active infection requiring antibiotics, antiviral agents, or antifungal agents within 14 days prior to randomization.
  15. Alcohol of any kind, grapefruit, and grapefruit juice within 48 hours prior to the 1st dose of study drug in each period until after the last blood draw in each period (i.e., Day 4 of Cycle 1 and 2).
  16. Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.
Female
30 Years and older
No
Contact: Deborah Brown 479-359-0318 dbrown@vectoroncology.com
Contact: Erica Rhea, CCRP 901-259-3231 erhea@vectoroncology.com
United States,   Moldova, Republic of,   Singapore
 
NCT02064829
STI-102
No
IgDraSol, Inc.
IgDraSol, Inc.
Vector Oncology
Study Director: Mike A Royal, MD Sorrento Therapeutics
IgDraSol, Inc.
June 2014

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