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Brief Title: Bioequivalence Study of IG-001 Versus Nab-paclitaxel in Metastatic or Locally Recurrent Breast Cancer
Official Title: An Open-label, Randomized, Multi-center, Single-Dose, 2-Sequence, 2-Period, Crossover, Comparative Bioequivalence Study of IG-001 (Cb-paclitaxel) 260 mg/m2 Versus Nab-paclitaxel 260 mg/m2 Administered Intravenously With an Open-Label Extension of IG-001 in Patients With Metastatic or Locally Recurrent Breast Cancer
Study ID: NCT02064829
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.
Detailed Description: This study is designed to compare the pharmacokinetics (PK) of IG-001 and nab-paclitaxel 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 nab-paclitaxel (Period 2). * Patients randomized to Group 2 will receive a single dose of nab-paclitaxel (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.
Minimum Age: 30 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Sorrento investigational site, Fayetteville, Arkansas, United States
Sorrento investigational site, Chattanooga, Tennessee, United States
Sorrento investigational site, Memphis, Tennessee, United States
Sorrento investigational site, Flower Mound, Texas, United States
Sorrento investigational site, Batumi, , Georgia
Sorrento investigational site, Tbilisi, , Georgia
Sorrento investigational site, Chisinau, , Moldova, Republic of
Sorrento investigational site, Bucharest, , Romania
Sorrento investigational site, Belgrade, , Serbia
Sorrento investigational site, Kragujevac, , Serbia
Sorrento investigational site, Sremska Kamenica, , Serbia
Sorrento investigational site, Zrenjanin, , Serbia
Sorrento investigational site, Singapore, , Singapore
Sorrento investigational site, Cherkasy, , Ukraine
Sorrento investigational site, Dnipropetrovsk, , Ukraine
Sorrento investigational site, Kharkiv, , Ukraine
Sorrento investigational site, Kyiv, , Ukraine
Sorrento investigational site, Lviv, , Ukraine
Sorrento investigational site, Sumy, , Ukraine
Sorrento investigational site, Vinnytsya, , Ukraine