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Spots Global Cancer Trial Database for Bioequivalence Study of IG-001 Versus Nab-paclitaxel in Metastatic or Locally Recurrent Breast Cancer

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 30 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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