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 July 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: July 24, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Metastatic Breast Cancer
Locally Recurrent Breast Cancer
Drug: Abraxane
Drug: IG-001
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by IgDraSol, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: March 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Reference Drug - Abraxane
260 mg/m2 administered intravenously over 30 minutes on Day 1
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
Experimental: Test Drug - IG-001
260 mg/m2 administered intravenously over 30 minutes on Day 1
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02064829

Contacts
Contact: Deborah Brown 479-359-0318 dbrown@vectoroncology.com
Contact: Erica Rhea, CCRP 901-259-3231 erhea@vectoroncology.com

Locations
United States, Arkansas
Highlands Oncology Group Recruiting
Fayetteville, Arkansas, United States, 72703
Contact: Amanda Nickel, RN    479-872-8130    anickel@hogonc.com   
Principal Investigator: J. Thaddeus Beck, MD         
United States, Tennessee
Associates in Oncology and Hematology Recruiting
Chattanooga, Tennessee, United States, 37421
Contact: Roberta Hoffman    423-622-2337    rhoffman@chemodok.com   
Principal Investigator: Jitendra Gandhi, MD         
The West Clinic Recruiting
Memphis, Tennessee, United States, 38120
Contact: Cindy Inman, RN, OCN, CCRP    901-683-0055 ext 1236    cinman@westclinic.com   
Principal Investigator: Lee S. Schwartzberg, MD         
United States, Texas
Texas Oncology - Abilene Not yet recruiting
Abilene, Texas, United States, 79606
Contact: Becky Garcia       Becky.Garcia@usoncology.com   
Principal Investigator: Anton M. Melnyk, Jr., MD         
Texas Oncology - Bedford Not yet recruiting
Bedford, Texas, United States, 76022
Principal Investigator: Thomas C. Anderson, MD         
Texas Oncology - Flower Mound Not yet recruiting
Flower Mound, Texas, United States, 75028
Principal Investigator: Derrick D. Nguyen, MD         
Moldova, Republic of
Oncologic Hospital, ICS ARENSIA Exploratory Medicine Recruiting
Chisinau, Moldova, Republic of
Contact: Maxim Bogus    +373.6821.2123    maxim.bogus@arensia-em.com   
Principal Investigator: Iurie Bulat         
Singapore
National Cancer Centre Singapore Recruiting
Singapore, Singapore, 169610
Contact: Samantha Yip    (65) 64368254    samantha.yip.l.j@nccs.com.sg   
Principal Investigator: Rebecca Dent, MD         
Sponsors and Collaborators
IgDraSol, Inc.
Vector Oncology
Investigators
Study Director: Mike A Royal, MD Sorrento Therapeutics
  More Information

No publications provided

Responsible Party: IgDraSol, Inc.
ClinicalTrials.gov Identifier: NCT02064829     History of Changes
Other Study ID Numbers: STI-102
Study First Received: February 14, 2014
Last Updated: July 24, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Singapore: Health Sciences Authority
Singapore: Institutional Review Board
Moldova: Ministry of Health
Moldova: Medicines Agency
Moldova: National Ethics Committee

Keywords provided by IgDraSol, Inc.:
Metastatic breast cancer
Locally recurrent breast cancer
Bioequivalence
IG-001
Abraxane
Paclitaxel
Pharmacokinetics

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014