Know Cancer

forgot password

A Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Malignancies

Phase 1
18 Years
Not Enrolling
Advanced Malignancies

Thank you

Trial Information

A Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Malignancies

Inclusion Criteria:

- Karnofsky Performance Status (KPS) > 70%.

- Histologically-confirmed advanced malignancy for which a standard, approved therapy
is not available.

- Adequate renal, liver, pancreatic and hematologic function

- Signed informed consent (sample IC form is provided in Appendix A).

Exclusion Criteria

- Administration of chemotherapy, biological, immunotherapy or investigational agent
(therapeutic or diagnostic) within 28 days

- Patients that require G-CSF and/or platelet support during screening and are likely
to require G-CSF and/or platelet support for the duration of the clinical trial.

- Patients with ongoing coagulopathies and/or taking anticoagulants

- Patients receiving intrathecal therapy.

- Known brain metastases.

- Pre-existing adrenal insufficiency; concomitant therapy with replacement
corticosteroids. Pre-existing acute or chronic pancreatitis.

- Significant cardiac disease.

- Pregnant or breast-feeding women.

- Concurrent, active secondary malignancy for which the patient is receiving therapy.
(Lymphoma patients with a diagnosis of a potentially hormone-sensitive tumor who are
without evidence of disease for this second malignancy may continue to receive
hormonal therapy).

- Patients with proteinuria Grade 2 or greater

- Active uncontrolled bacterial or fungal infection requiring systemic therapy;
infection requiring parenteral antibiotics.

- Patients who are known to be HIV positive or have active Hepatitis A, B, or C

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

To determine Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of NPI 0052 when administered via IV injection on Days 1, 8, 15 during a four week cycle for patients with advanced malignancies

Outcome Time Frame:


Safety Issue:


Principal Investigator

Robert Corringham, MD

Investigator Role:

Study Director

Investigator Affiliation:

Triphase Research and Development I Corp, Chief Medical Officer


Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

NPI 0052-102



Start Date:

July 2007

Completion Date:

April 2013

Related Keywords:

  • Advanced Malignancies
  • multiple myeloma
  • leukemias (inc. CLL)
  • lymphomas
  • cutaneous lymphoma
  • marginal zone lymphoma
  • advanced malignancies without standard treatment options
  • Neoplasms