Clinical Trials /

PU-H71 With Nab-paclitaxel (Abraxane) in Metastatic Breast Cancer

NCT03166085

Description:

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).

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: PU-H71 With Nab-paclitaxel (Abraxane) in Metastatic Breast Cancer
  • Official Title: A Phase 1b Study of PU-H71 With Nab-paclitaxel (Abraxane) in Patients With HER2-Negative Metastatic Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: 17-093
  • NCT ID: NCT03166085

Conditions

  • Metastatic Breast Cancer

Interventions

DrugSynonymsArms
PU-H71PU-H71 With Nab-paclitaxel (Abraxane)
Nab-paclitaxelAbraxanePU-H71 With Nab-paclitaxel (Abraxane)

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
PU-H71 With Nab-paclitaxel (Abraxane)ExperimentalPU-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
  • Nab-paclitaxel

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Tolerated Dose (MTD)
Time Frame:1 year
Safety Issue:
Description: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.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • HER2-Negative
  • PU-H71
  • Nab-paclitaxel (Abraxane)
  • 17-093

Last Updated

May 23, 2017