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

NCT02064829 | Completed

• 1 other identifier: STI-102
• Study Type: interventional
• Target: 111
• Locations: 7 countries
• Sites: 20

Brief Summary

The purpose of this study is to demonstrate bioequivalence of IG-001 versus nab-paclitaxel in female patients with metastatic or locally recurrent breast cancer. In addition, the study will compare the safety and tolerance of IG-001 and nab-paclitaxel 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.

Conditions

Metastatic Breast Cancer; Locally Recurrent Breast Cancer

Keywords

Metastatic breast cancer; Locally recurrent breast cancer; Bioequivalence; IG-001; nab-paclitaxel; Paclitaxel; Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Maximum observed concentration of paclitaxel (Cmax)

  Predose: 30 min; During infusion: 30 min; Post-infusion: 5, 10, 15, 30, and 45 min, and 1, 1.5, 2, 4, 7, 10, 24, 30 and 48 or 72 hr

• Area under the concentration-time curve from time zero to infinite time of paclitaxel (AUC 0-inf)

  Predose: 30 min; During infusion: 30 min; Post-infusion: 5, 10, 15, 30, and 45 min, and 1, 1.5, 2, 4, 7, 10, 24, 30 and 48 or 72 hr

Study Arms (2)

Reference Drug - Nab-paclitaxel

ACTIVE COMPARATOR

260 mg/m2 administered intravenously over 30 minutes on Day 1

Drug: Nab-paclitaxel

Test Drug - IG-001

EXPERIMENTAL

260 mg/m2 administered intravenously over 30 minutes on Day 1

Drug: IG-001

Interventions

Nab-paclitaxel DRUG

260 mg/m2 administered intravenously over 30 minutes on Day 1 every 3 weeks

Also known as: Paclitaxel albumin-bound particles for injectable suspension

Reference Drug - Nab-paclitaxel

IG-001 DRUG

260 mg/m2 administered intravenously over 30 minutes on Day 1 every 3 weeks

Also known as: Paclitaxel polymeric micelles for injectable suspension, Genexol-PM, Cynviloq

Test Drug - IG-001

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer patient who
• Has histologically confirmed diagnosis of breast cancer.
• Has stage IV or locally recurrent breast cancer per the American Joint Committee on Cancer Staging Manual,7th edition.
• Has failed any single agent or combination chemotherapy for metastatic or locally recurrent disease.
• Has agreed to participate in the study and signed the informed consent form prior to participation in any study activities.
• Sex and Age: Female ≥ 30 years of age.
• Body surface area (BSA) that is within 1.2 to 2.2 m2, calculated using the Mosteller or DuBois Formula. The same formula must be used consistently for any given patient.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Sitting blood pressure (BP) and heart rate (HR): Systolic and diastolic BP (SBP/DBP) and HR in the normal range or no worse than Grade 1 abnormality by the Common Terminology Criteria for Adverse Events version 4, as amended (CTCAE).
• Hematology/chemistry: Patient has adequate hematological, renal, and hepatic function as defined by the following Screening laboratory values obtained within 7 days prior to randomization and assessed based on local labs (patients should not have received a transfusion within 7 days before the Screening laboratory assessments):
• Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3 (1.5x10\^9/L)
• Platelet count ≥ 100,000 cells/mm3 (100x10\^9/L)
• Hemoglobin ≥ 9 g/dL
• Serum creatinine ≤ 1.5 x the upper limit of normal (ULN)
• Total bilirubin ≤ 1.25 x ULN

You may not qualify if:

• Patients with a history of other malignancies, except for adequately treated nonmelanoma skin cancer, curatively treated in-situ carcinoma of the cervix, in-situ carcinoma of the breast or other solid tumors with no evidence of recurrence for ≥ 5 years.
• Patients who have previously received a taxane within the 30 days prior to randomization.
• Patients who have not completely recovered from any toxicities from previous chemotherapy, hormone therapy, immunotherapy, or radiotherapies Grade 1 or higher by CTCAE, with the exception of alopecia.
• Prior chemotherapy must be completed at least 30 days prior 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.
• Patient had major surgery within 30 days prior to randomization, or patient has not recovered from prior major surgery.
• Sensory / Peripheral neuropathy of Grade 2 or higher by CTCAE at Screening.
• Patients with known brain metastases, with the exception of patients who have completed surgery and/or radiotherapy at least 30 days prior to randomization, have completed any steroids as treatment for the metastases at least 30 days prior to randomization, and who are currently asymptomatic.
• Known history or presence of any clinically significant disease or condition other than cancer unless determined as not clinically significant by the Investigator.
• History of difficulty with vascular access.
• Known history or presence of:
• Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
• Alcohol or drug abuse or dependence within one year prior to randomization
• Hypersensitivity or idiosyncratic reaction to paclitaxel, its excipients, and/or related substances, including, albumin and PEG.
• 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.
• Use of any CYP2C8 and CYP3A4 inhibitor (e.g., ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, cimetidine, ritonavir, saquinavir, indinavir, and nelfinavir) or inducer (e.g., rifampicin, carbamazepine, phenytoin, efavirenz, and nevirapine) in the previous 14 days before randomization until the last PK sample is obtained in the study.

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead

Study Sites (20)

Sorrento investigational site

Fayetteville, Arkansas, 72703, United States

Location

Sorrento investigational site

Chattanooga, Tennessee, 37421, United States

Location

Sorrento investigational site

Memphis, Tennessee, 38120, United States

Location

Sorrento investigational site

Flower Mound, Texas, 75028, United States

Location

Sorrento investigational site

Batumi, Georgia

Location

Sorrento investigational site

Tbilisi, Georgia

Location

Sorrento investigational site

Chisinau, Moldova

Location

Sorrento investigational site

Bucharest, Romania

Location

Sorrento investigational site

Belgrade, Serbia

Location

Sorrento investigational site

Kamenitz, Serbia

Location

Sorrento investigational site

Kragujevac, Serbia

Location

Sorrento investigational site

Zrenjanin, Serbia

Location

Sorrento investigational site

Singapore, 169610, Singapore

Location

Sorrento investigational site

Cherkasy, Ukraine

Location

Sorrento investigational site

Dnipropetrovsk, Ukraine

Location

Sorrento investigational site

Kharkiv, Ukraine

Location

Sorrento investigational site

Kyiv, Ukraine

Location

Sorrento investigational site

Lviv, Ukraine

Location

Sorrento investigational site

Sumy, Ukraine

Location

Sorrento investigational site

Vinnytsia, Ukraine

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

130-nm albumin-bound paclitaxel; genexol-PM

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2014
• First Posted: February 17, 2014
• Study Start: March 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 25, 2016

Record last verified: 2016-03

Locations

US (4); RO (1); SG (1); SE (4); UA (7); MO (1); GE (2)