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Bioequivalence Study of IG-001 Versus Nab-paclitaxel in Metastatic or Locally Recurrent Breast Cancer | Clinical Trials | Clareo Health

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

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

NCT02064829•Sorrento Therapeutics, Inc.

View on ClinicalTrials.gov

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

Age

30 - No limit years

Sex

FEMALE

Healthy Volunteers

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.
•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 ≥ 30 years of age.
•3. 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.
•4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
•5. 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).
•6. 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):
+13 more criteria

Exclusion Criteria

•1. 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.
•2. Patients who have previously received a taxane within the 30 days prior to randomization.
•3. 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.
•4. 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.
•5. Patient had major surgery within 30 days prior to randomization, or patient has not recovered from prior major surgery.
•6. Sensory / Peripheral neuropathy of Grade 2 or higher by CTCAE at Screening.
•7. 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.
•8. Known history or presence of any clinically significant disease or condition other than cancer unless determined as not clinically significant by the Investigator.
•9. History of difficulty with vascular access.
•10. Known history or presence of:
+7 more criteria

Locations (20)

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

Sorrento investigational site

Bucharest, Romania

Sorrento investigational site

Belgrade, Serbia

Sorrento investigational site

Kamenitz, Serbia

Key Dates

Start Date

March 1, 2014

Primary Completion Date

February 1, 2015

Completion Date

July 1, 2015

Last Updated

March 25, 2016

Enrollment

111

ACTUAL participants

Conditions

Metastatic Breast CancerLocally Recurrent Breast Cancer

Interventions

Nab-paclitaxel

DRUG

IG-001

DRUG

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 25, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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