Metastatic Breast CancerTRIBECANCT02064829
Bioequivalence Study of IG-001 Versus Nab-paclitaxel in Metastatic or Locally Recurrent Breast Cancer
A study testing Nab-paclitaxel and IG-001 in people with Metastatic Breast Cancer and Locally Recurrent Breast Cancer, run by Sorrento Therapeutics, Inc. at 20 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer, Locally Recurrent Breast Cancer
- What is being tested?
- Nab-paclitaxel and IG-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 20 sitesin 7 countries
- Study dates
- Mar 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
- AST (SGOT) ≤ 2.5 x ULN
- ALT (SGPT) ≤ 2.5 x ULN
- All other clinical laboratory values deemed normal or not clinically significant by the Principal Investigator/Sub-Investigator.
- Pregnancy status: Patients must be non-pregnant (due to teratogenic or abortifacient effects of paclitaxel) from 30 days prior to randomization until 30 days after the last dose of study drug. Women who are not post-menopausal ≥ 52 weeks or surgically sterilized (e.g., hysterectomy, bilateral oophorectomy, bilateral tubal ligation) are considered of childbearing potential. For women of childbearing potential (WOCBP), a serum pregnancy test (β-hCG) must be negative at Screening, and a urine pregnancy test must be negative prior to each dose of study drug.
- Breastfeeding: Patients must not be lactating or breastfeed during the study. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding must be discontinued prior to the first dose of study drug.
- Contraception: If sexually active, WOCBP must agree to use contraception considered adequate and appropriate by the Investigator throughout the course of the study and for 30 days after she receives the last dose of study drug.
- Able and willing to adhere to all protocol requirements and study procedures throughout the study.
- Ability to comprehend and be informed of the nature of the study, as assessed by study clinic staff.
Who cannot join
- 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.
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- 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.
- Acute active infection requiring treatment within 14 days prior to randomization.
- Patients with any significant history of non-compliance or inability to reliably grant informed consent.
Trial locations and contacts
20 sites in 7 countries.
20 sites in 7 countries
Ukraine7 sites
Sorrento investigational site
Cherkasy
Sorrento investigational site
Dnipropetrovsk
Sorrento investigational site
Kharkiv
Sorrento investigational site
Kyiv
Sorrento investigational site
Lviv
Sorrento investigational site
Sumy
Sorrento investigational site
Vinnytsia
United States4 sites
Sorrento investigational site
Chattanooga, Tennessee, 37421
Sorrento investigational site
Fayetteville, Arkansas, 72703
Sorrento investigational site
Flower Mound, Texas, 75028
Sorrento investigational site
Memphis, Tennessee, 38120
Serbia4 sites
Sorrento investigational site
Belgrade
Sorrento investigational site
Kamenitz
Sorrento investigational site
Kragujevac
Sorrento investigational site
Zrenjanin
Georgia2 sites
Sorrento investigational site
Batumi
Sorrento investigational site
Tbilisi
About this study
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
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.
Read the 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.
- Being tested
- Nab-paclitaxel, IG-001
- Keywords
- Metastatic breast cancer, Locally recurrent breast cancer, Bioequivalence, IG-001, nab-paclitaxel, Paclitaxel, Pharmacokinetics
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab-paclitaxelDrug
Also called Paclitaxel albumin-bound particles for injectable suspension
260 mg/m2 administered intravenously over 30 minutes on Day 1 every 3 weeks
IG-001Drug
Also called Paclitaxel polymeric micelles for injectable suspension, Genexol-PM, Cynviloq
260 mg/m2 administered intravenously over 30 minutes on Day 1 every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Reference Drug - Nab-paclitaxel | Active comparator | 260 mg/m2 administered intravenously over 30 minutes on Day 1 Receives: Drug: Nab-paclitaxel |
| Test Drug - IG-001 | Experimental | 260 mg/m2 administered intravenously over 30 minutes on Day 1 Receives: Drug: IG-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration of paclitaxel (Cmax)
Measured: 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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorrento Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064829
- Sponsor's protocol ID
- STI-102
- Acronym
- TRIBECA
- Status last verified
- Mar 2016
- First submitted
- 14 Feb 2014
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02064829
- Acronym / sponsor ID
- TRIBECA / STI-102
- Keywords
- Metastatic breast cancer, Locally recurrent breast cancer, Bioequivalence, IG-001, nab-paclitaxel, Paclitaxel, Pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Sorrento Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference Drug - Nab-paclitaxel | Active comparator | Drug: Nab-paclitaxel260 mg/m2 administered intravenously over 30 minutes on Day 1 |
| Test Drug - IG-001 | Experimental | Drug: IG-001260 mg/m2 administered intravenously over 30 minutes on Day 1 |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Breast cancer patient who
- 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).
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nab-paclitaxelAlso: Paclitaxel albumin-bound particles for injectable suspension260 mg/m2 administered intravenously over 30 minutes on Day 1 every 3 weeks | Drug | Reference Drug - Nab-paclitaxel |
| IG-001Also: Paclitaxel polymeric micelles for injectable suspension, Genexol-PM, Cynviloq260 mg/m2 administered intravenously over 30 minutes on Day 1 every 3 weeks | Drug | Test Drug - IG-001 |
Primary outcome
Maximum observed concentration of paclitaxel (Cmax)
Time frame: 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)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nab-paclitaxel and IG-001 in people with Metastatic Breast Cancer and Locally Recurrent Breast Cancer, run by Sorrento Therapeutics, Inc. at 20 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Ukraine, United States, Serbia, Georgia, Moldova and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed concentration of paclitaxel (Cmax) (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2016.