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A Phase I Dose Escalation Study of NKP-1339 Administered on Days 1, 8 and 15 of Each 28-Day Cycle in Patients With Advanced Solid Tumors Refractory to Treatment


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Tumors

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Trial Information

A Phase I Dose Escalation Study of NKP-1339 Administered on Days 1, 8 and 15 of Each 28-Day Cycle in Patients With Advanced Solid Tumors Refractory to Treatment


NKP-1339 is a novel GRP78 targeted ruthenium based anti-cancer compound which is
intravenously administered. GRP78 is a key regulator of misfolded protein processing, which
is unregulated in cancer cells. In nonclinical anti-tumor studies, NKP-1339 showed activity
against many tumor types, including those resistant to platinum and other standard
anti-cancer agents. This Phase I trial evaluates the safety, tolerability, maximum tolerated
dose, pharmacokinetics, and pharmacodynamics of NKP-1339.


Inclusion Criteria:



- Patients ≥ 18 years with histologically or cytologically confirmed advanced solid
tumors refractory to standard therapies who have signed an IRB approved Informed
Consent Form (ICF).

- ECOG PS 0 or 1.

- Adequate hematologic, hepatic and renal function

- Minimum life expectancy ≥ 12 weeks

Exclusion Criteria:

- No supplemental Iron, i.e., therapeutic or as part of a multivitamin regimen.

- No chemotherapy, immunotherapy, or radiotherapy for < 4 weeks, BMTs < 9 months or
major surgery < 3 weeks.

- No symptomatic central nervous system metastases. No primary brain tumors or known
brain metastasis unless clinically stable and on stable or reducing dose of steroids.

- No evidence of ischemia, MI within the past 6 months, or other significant
abnormality on ECG.

- No clinically significant active infection including HIV, hepatitis B, or hepatitis
C.

- No Peripheral neuropathy ≥ Grade 2

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of participants with related adverse events

Outcome Description:

The incidence and severity of related adverse events and laboratory abnormalities will be used to assess the safety and tolerability of NKP-1339.

Outcome Time Frame:

8 weeks

Safety Issue:

Yes

Principal Investigator

Daniel D. Von Hoff, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

TGEN Clinical Research Services at Scottsdale Healthcare

Authority:

United States: Food and Drug Administration

Study ID:

NKP-1339-09-002

NCT ID:

NCT01415297

Start Date:

September 2009

Completion Date:

May 2013

Related Keywords:

  • Solid Tumors
  • Phase 1
  • advanced solid tumors
  • Neoplasms

Name

Location

The Sarah Cannon Research InstituteNashville, Tennessee  37203
TGen Clinical Research Services at Scottsdale HealthcareScottsdale, Arizona  85258