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The First-in-human Phase I Trial of PU-H71 in Patients With Advanced Malignancies

Phase 1
18 Years
Open (Enrolling)
Metastatic Solid Tumor, Lymphoma

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Trial Information

The First-in-human Phase I Trial of PU-H71 in Patients With Advanced Malignancies

Inclusion Criteria:

- Histologically documented (Pathology confirmed at MSKCC), incurable, locally advanced
or metastatic solid tumor malignancy or lymphoma; the safety-expansion phase will be
open to accrual only for patients with MPN.

- ≥ 18 years of age

- Radiographically detectable (Either FDG-PET, CT scan/ MRI or Bone Scan) or measurable
disease. Measurable disease is defined as at least one measurable lesion ≥ 1 cm on CT
scan .

- Prior therapy for advanced malignancy with no current curative option

- Neutrophil count ≥ 1,000/μL, platelet count ≥ 75,000/μL, and hemoglobin ≥ 9 g/dL
(hematologic parameters must be assessed at least 14 days after a prior transfusion,
if any)

- Serum bilirubin ≤ 1.5 mg/dL;

- AST and ALT ≤ 1.5 × ULN

- Serum creatinine ≤ 1.5 mg/dL or creatinine clearance of ≥ 50 mL/min based on a
24-hour urine collection

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

- Patients with HIV/AIDS are allowed on study if they have an undetectable viral load,
CD4 > 300 and on stable Highly Active Antiretroviral Therapy (HAART) regimen for 1

- Patients who have been treated for at least two weeks with stable doses of
corticosteroids to address conditions unrelated to their malignancy will be allowed
to continue this treatment during enrollment on the current trial.

- Patients currently being treated with a gonadotropin-releasing hormone agonist (GnRH
agonist), bicalutamide or with bisphosphonates may continue treatment while on
clinical trial PU-H71 as long as the treatment has been initiated before the study
start. GnRH agonist must have been well tolerated for at least three months.

- Signed written informed consent and HIPAA consent.

Exclusion Criteria:

- Ejection fraction < 50%, as determined by echocardiogram or MUGA scan

- Symptomatic brain or CNS metastases. Previously treated and stable CNS disease is

Any of the following for the treatment of cancer within 2 weeks of first study treatment:
chemotherapy, radiotherapy, immunotherapy, experimental therapy or biologic therapy.

- Any major surgical procedure or radiation within 4 weeks of first study treatment

- History of clinically symptomatic liver disease, including viral or other hepatitis,
or cirrhosis

- Pregnancy or lactation

- Hepatitis or other active infections

- 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

- Systemic corticosteroids (e.g. prednisone >12.5 mg/day or dexamethasone > 2 mg/day)
for the purpose of palliating tumor-related symptoms will not be allowed within 1
week of starting treatment on trial.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the safety of PU-H71 in patients with advanced malignancies.

Outcome Description:

Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

John Gerecitano, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

July 2011

Completion Date:

July 2014

Related Keywords:

  • Metastatic Solid Tumor
  • Lymphoma
  • PU-H71
  • Solid Tumor
  • Lymphoma
  • 11-041
  • incurable, locally advanced or metastatic solid tumor malignancy or lymphoma
  • Neoplasms
  • Lymphoma



Memorial Sloan-Kettering Cancer Center New York, New York  10021