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. |
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Condition | Metastatic Breast Cancer Locally Recurrent Breast Cancer |
Intervention | Drug: Abraxane Drug: IG-001 |
Phase | Phase 1 |
Sponsor | IgDraSol, Inc. |
Responsible Party | IgDraSol, Inc. |
ClinicalTrials.gov Identifier | NCT02064829 |
First Received | February 14, 2014 |
Last Updated | April 15, 2014 |
Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | February 14, 2014 |
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Last Updated Date | April 15, 2014 |
Start Date | March 2014 |
Estimated Primary Completion Date | April 2015 |
Current Primary Outcome Measures |
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Current 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] |
Descriptive Information[ + expand ][ + ]
Brief Title | Bioequivalence Study of IG-001 Versus Abraxane in Metastatic or Locally Recurrent Breast Cancer |
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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 |
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 Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition |
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Intervention | Drug: Abraxane 260 mg/m2 administered intravenously over 30 minutes on Day 1 every 3 weeks Other Names:
260 mg/m2 administered intravenously over 30 minutes on Day 1 every 3 weeks Other Names:
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Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 100 |
Estimated Completion Date | April 2015 |
Estimated Primary Completion Date | January 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. |
Gender | Female |
Ages | 30 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Deborah Brown 479-359-0318 dbrown@acornresearch.net |
Location Countries | United States, Singapore |
Administrative Information[ + expand ][ + ]
NCT Number | NCT02064829 |
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Other Study ID Numbers | STI-102 |
Has Data Monitoring Committee | No |
Information Provided By | IgDraSol, Inc. |
Study Sponsor | IgDraSol, Inc. |
Collaborators | ACORN Research, LLC |
Investigators | Study Director: Vuong Trieu, PhD IgDraSol, Inc. |
Verification Date | April 2014 |
Locations[ + expand ][ + ]
Associates in Oncology and Hematology | Chattanooga, Tennessee, United States, 37421 Contact: Gena Bagwell | 423-622-2337 | gbagwell@chemodok.comPrincipal Investigator: Jitendra Gandhi, MD Recruiting |
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The West Clinic | Memphis, Tennessee, United States, 38120 Contact: Cindy Inman, RN, OCN, CCRP | 901-683-00551236 | cinman@westclinic.comPrincipal Investigator: Lee S Schwartzberg, MD Recruiting |
National Cancer Centre Singapore | Singapore, Singapore, 169610 Contact: Samantha Yip | (65) 64368254 | samantha.yip.l.j@nccs.com.sgPrincipal Investigator: Mabel Wong, MD Recruiting |