- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03166085
PU-H71 With Nab-paclitaxel (Abraxane) in Metastatic Breast Cancer
December 17, 2021 updated by: Memorial Sloan Kettering Cancer Center
A Phase 1b Study of PU-H71 With Nab-paclitaxel (Abraxane) in Patients With HER2-Negative Metastatic Breast Cancer
The purpose of this study is to decide the best dose of the study drug, PU-H71, that can be given in combination with the standard chemotherapy drug, nab-paclitaxel (Abraxane).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 years or older
- Signed informed consent
- Patients must have histologically confirmed HER2-negative breast cancer (defined as IHC 0 or 1+ and/or fluorescence in situ hybridization [FISH] < 2.0), that is metastatic in stage
- For estrogen receptor (ER)-positive breast cancer, patients must be considered refractory to endocrine therapy, having received and progressed through at least one prior line of endocrine therapy, or are intolerant of endocrine therapy
- All patients must have progressed on at least one line of cytotoxic therapy for metastatic disease
- Patients must have evidence of progressive disease
- Measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
- Hematologic parameters: white blood cell (WBC) count of ≥ 3000/ul, absolute neutrophil count (ANC) ≥ 1500/ul, platelets ≥ 100,000/ul, hemoglobin ≥ 9.0 g/dl
- Non-hematologic parameters: bilirubin ≤ 1.5 mg/dl, AST/ALT ≤ 3.0 x upper limit of normal (ULN) (≤ 5.0 x ULN if liver metastases are involved)
- Serum creatinine < 1.5 xULN or CrCl > 40 mL/min (measured or calculated using the Cockcroft-Gault formula)
- An Eastern Cooperative Oncology Group performance status of 0-2
- Life expectancy of 3 months or more as assessed by the investigator
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- Negative β-human chorionic gonadotropin (hCG) pregnancy test for premenopausal women of reproductive capacity (those who are biologically capable of having children) and for women less than 12 months after menopause.
- Women of childbearing potential must agree and commit to the use of a highly effective method of contraception. Men must agree and commit to use a barrier method of contraception while on treatment and for 3 months after last dose of investigational products.
Exclusion Criteria:
- Symptomatic brain or CNS metastases. Previously treated and stable CNS disease is allowed.
- Any of the following for the treatment of cancer within 2 weeks of first study treatment: chemotherapy, immunotherapy, experimental therapy, or biologic therapy.
- Radiation therapy (other than palliative radiation to bony metastases) as cancer therapy within 4 weeks prior to initiation of study treatment
- Any major surgical procedure within 4 weeks of first study treatment
- Prior treatment with Abraxane
- Active liver disease, including viral or other hepatitis, or cirrhosis
- Pregnancy or lactation
- Other active infections aside from hepatitis
- Any other significant medical condition not under control, including any acute coronary syndrome within the past 6 months.
- Patients with a permanent pacemaker
- Patients with a QTc > 480 ms in the baseline EKG
- Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable/evaluable disease
- Peripheral neuropathy of grade ≥ 2 per NCI CTCAE, Version 4.0, at the time of or within 3 weeks prior to the first study therapy
- Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results in the judgment of the investigator
- History of an invasive second primary malignancy diagnosed within the previous 3 years, except for appropriately treated stage I endometrial or cervical carcinoma or prostate carcinoma treated surgically, and non-melanoma skin cancer.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: PU-H71 With Nab-paclitaxel (Abraxane)
PU-H71 will be given as an intravenous infusion on Day 1 of a 21 day cycle and nab-paclitaxel will be administered at a dose of 260mg/m2 intravenously on Day 1.
Both drugs will be administered on the same day, in sequence, with nab-paclitaxel being administered first followed by administration of PU-H71 as close as possible to 6 hours later (+/-1 hour).
PU-H71 will be administered intravenously over a 1 hour period; nab-paclitaxel will be administered per standard guidelines as a 30-minute intravenous infusion.
|
PU-H71 will be given as an intravenous infusion on Day 1 of a 21 day cycle
nab-paclitaxel will be administered at a dose of 260mg/m2 intravenously on Day 1
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Tolerated Dose (MTD)
Time Frame: 1 year
|
The MTD will be the dose level at which 0/6 or 1/6 patients experience excessive toxicity with the next higher dose having at least 2/3 or 2/6 patients experiencing excessive toxicity.
This means that if only 3 patients have been treated at a particular dose level and none of them had excessive toxicity, another 3 patients will be treated to verify that no more than 1 out of 6 patients had excessive toxicity.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 23, 2017
Primary Completion (ACTUAL)
December 14, 2021
Study Completion (ACTUAL)
December 14, 2021
Study Registration Dates
First Submitted
May 23, 2017
First Submitted That Met QC Criteria
May 23, 2017
First Posted (ACTUAL)
May 24, 2017
Study Record Updates
Last Update Posted (ACTUAL)
December 20, 2021
Last Update Submitted That Met QC Criteria
December 17, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- 9H-purine-9-propanamine, 6-amino-8-((6-iodo-1,3-benzodioxol-5-yl)thio)-N-(1-methylethyl)-
Other Study ID Numbers
- 17-093
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Metastatic Breast Cancer
-
GlycoMimetics IncorporatedTerminatedBreast Cancer | Breast Cancer Metastatic | HR+ Metastatic Breast CancerUnited States
-
Gilead SciencesRecruitingStudy of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors (ASCENT-J02)Advanced Solid Tumor | Metastatic Urothelial Cancer | Metastatic Triple-Negative Breast Cancer | HR+/HER2- Metastatic Breast CancerJapan
-
BriaCell Therapeutics CorporationRecruitingBreast Cancer | Breast Neoplasm | Metastatic Breast Cancer | Breast Cancer Metastatic | End Stage CancerUnited States
-
OBI Pharma, IncCompletedMetastatic Colorectal Cancer | Metastatic Lung Cancer | Metastatic Breast Cancer | Metastatic Gastric CancerTaiwan
-
Massachusetts General HospitalPuma Biotechnology, Inc.; Celcuity, Inc.WithdrawnMetastatic Breast Cancer | Invasive Breast Cancer | HER2-negative Breast Cancer | ER Positive Breast Cancer | PR-Positive Breast Cancer | Stage IV (Metastatic) Breast CancerUnited States
-
Novartis PharmaceuticalsCompletedMetastatic Breast Cancer | Postmenopausal Women | Locally Advanced Metastatic Breast CancerIsrael
-
BriaCell Therapeutics CorporationLumaBridgeEnrolling by invitationBreast Cancer | Breast Neoplasm | Metastatic Breast Cancer | Breast Cancer MetastaticUnited States
-
Prof. Wolfgang JanniEli Lilly and CompanyRecruitingHormone Receptor-positive Metastatic Breast Cancer | HER2-negative Metastatic Breast CancerGermany, Switzerland
-
Institut de Recherches Internationales ServierADIR, a Servier Group companyCompletedMetastatic Breast Cancer | Metastatic Triple Negative Breast CancerJapan, Belgium, France, Netherlands
-
Hoffmann-La RocheCompletedHER2-Positive Metastatic Breast Cancer | HER2-Negative Metastatic Breast Cancer | Locally Advanced or Early Breast CancerUnited States
Clinical Trials on PU-H71
-
Memorial Sloan Kettering Cancer CenterCompletedLymphoma | Metastatic Solid Tumor | Myeloproliferative Neoplasms (MPN)United States
-
National Cancer Institute (NCI)TerminatedLymphoma | Solid TumorsUnited States
-
Samus Therapeutics, Inc.TerminatedPrimary Myelofibrosis (PMF) | Post-Polycythemia Vera Myelofibrosis (Post-PV MF) | Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF)United States
-
Samus Therapeutics, Inc.TerminatedPrimary Myelofibrosis | Myelofibrosis | Post-polycythemia Vera Myelofibrosis | Post-essential Thrombocythemia MyelofibrosisUnited States
-
The Hong Kong Polytechnic UniversityCompletedPrevention of Pressure UlcersChina
-
PU sensor ABScandinavian CROCompleted
-
Samus Therapeutics, Inc.TerminatedAlzheimer's DiseaseUnited States
-
Staffordshire UniversityIndia Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes HospitalsCompletedDiabetes Complications | Diabetic NeuropathiesIndia
-
University GhentCare of Sweden ABCompletedPressure Ulcer | Pressure Injury | Pressure Ulcer, Buttock | Pressure SoreBelgium
-
Samus Therapeutics, Inc.Memorial Sloan Kettering Cancer Center; Weill Medical College of Cornell University and other collaboratorsTerminatedLymphoma | Alzheimer Disease | Myeloma | Solid MalignancyUnited States