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

Overview[ - collapse ][ - ]

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.
ConditionMetastatic Breast Cancer
Locally Recurrent Breast Cancer
InterventionDrug: Abraxane
Drug: IG-001
PhasePhase 1
SponsorIgDraSol, Inc.
Responsible PartyIgDraSol, Inc.
ClinicalTrials.gov IdentifierNCT02064829
First ReceivedFebruary 14, 2014
Last UpdatedApril 15, 2014
Last verifiedApril 2014

Tracking Information[ + expand ][ + ]

First Received DateFebruary 14, 2014
Last Updated DateApril 15, 2014
Start DateMarch 2014
Estimated Primary Completion DateApril 2015
Current 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, 12 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, 12 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, 12 hr, 24 hr, 48 hr, 72 hr] [Designated as safety issue: No]
Current Secondary Outcome MeasuresNumber 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]

Descriptive Information[ + expand ][ + ]

Brief TitleBioequivalence Study of IG-001 Versus Abraxane in Metastatic or Locally Recurrent Breast Cancer
Official TitleAn 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
Brief Summary
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.
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.
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition
  • Metastatic Breast Cancer
  • Locally Recurrent Breast Cancer
InterventionDrug: 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
Study Arm (s)
  • Active Comparator: Reference Drug - Abraxane
    260 mg/m2 administered intravenously over 30 minutes on Day 1
  • Experimental: Test Drug - IG-001
    260 mg/m2 administered intravenously over 30 minutes on Day 1

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment100
Estimated Completion DateApril 2015
Estimated Primary Completion DateJanuary 2015
Eligibility 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 2.0 m2, calculated using the Mosteller
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 14days 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.
GenderFemale
Ages30 Years
Accepts Healthy VolunteersNo
ContactsContact: Deborah Brown
479-359-0318
dbrown@acornresearch.net
Location CountriesUnited States, Singapore

Administrative Information[ + expand ][ + ]

NCT Number NCT02064829
Other Study ID NumbersSTI-102
Has Data Monitoring CommitteeNo
Information Provided ByIgDraSol, Inc.
Study SponsorIgDraSol, Inc.
CollaboratorsACORN Research, LLC
Investigators Study Director: Vuong Trieu, PhD IgDraSol, Inc.
Verification DateApril 2014

Locations[ + expand ][ + ]

Associates in Oncology and Hematology
Chattanooga, Tennessee, United States, 37421
Contact: Gena Bagwell | 423-622-2337 | gbagwell@chemodok.com
Principal Investigator: Jitendra Gandhi, MD
Recruiting
The West Clinic
Memphis, Tennessee, United States, 38120
Contact: Cindy Inman, RN, OCN, CCRP | 901-683-00551236 | cinman@westclinic.com
Principal Investigator: Lee S Schwartzberg, MD
Recruiting
National Cancer Centre Singapore
Singapore, Singapore, 169610
Contact: Samantha Yip | (65) 64368254 | samantha.yip.l.j@nccs.com.sg
Principal Investigator: Mabel Wong, MD
Recruiting