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A Multicenter Phase I/IIB Study of NPC-1C in Combination With Gemcitabine in Patients With Metastatic or Locally Advanced Pancreatic Cancer Previously Treated With FOLFIRINOX

Phase 1/Phase 2
18 Years
Open (Enrolling)
Metastatic, Locally Advanced Unresectable or Recurrent Pancreatic Cancer.

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Trial Information

A Multicenter Phase I/IIB Study of NPC-1C in Combination With Gemcitabine in Patients With Metastatic or Locally Advanced Pancreatic Cancer Previously Treated With FOLFIRINOX

During Part 1 of the study, the safe and tolerable dose of NPC-1C in combination with
Gemcitabine will be determined. Upon completion of the phase I study up to 28 patients will
evaluated to explore clinical response.

Inclusion Criteria

Inclusion Criteria

- Subjects with recurrent, locally advanced unresectable or metastatic adenocarcinoma
of the pancreas who have progressed after primary therapy with FOLFIRINOX or
FOLFIRINOX-like regimen or were intolerant of it.

- IHC greater than or equal to 20 percent of tumor on tissue sections must stain with

- 18 years of age or older.

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

- Have an anticipated life expectancy of greater than 12 weeks.

- Have recovered from any acute toxicity related to prior therapy.

- If female, is post-menopausal, surgically sterilized or willing to use an effective
method of contraception for the duration of the study and for 3 months after the end
of treatment. If male, has agreed to use barrier method for contraception for the
duration of the study and for 3 months after the end of treatment.

- Must be willing to sign a written informed consent.

- Laboratory tests must meet minimum safety requirements

1. Hemoglobin greater than or equal to 8.5 g/dL (may be receiving supportive

2. ANC greater than or equal to 1,500 K/uL

3. Platelets greater than or equal to 100 K/uL

4. Total bilirubin less than or equal to 2 mg/dL

5. ALT/AST less than or equal to 3 times ULN or less than or equal to 5 times ULN
in the setting of liver metastases.

6. Creatinine less than or equal to 1.5 mg/dL or creatinine clearance greater than
40 mL/min/1.73 m2 for patients with creatinine levels above institutional
normal, as calculated by the Cockcroft Gault formula.

- Men and women of all races and ethnic groups are eligible for this trial.

Exclusion Criteria

- Have received a second line chemotherapy after progressing on or not tolerating
treatment with FOLFIRINOX as a first line.

- Have received an investigational agent for their pancreatic cancer.

- Have known brain metastases.

- Have had any major surgery within four weeks of enrollment.

- Have any clinically detectable ascites.

- Have received Gemcitabine for palliative treatment or progressed while receiving it
or is within 3 months of completion in the adjuvant setting.

- Have uncontrolled concomitant illness including, but not limited to, ongoing or
active infection, symptomatic congestive heart failure, unstable angina pectoris, or
cardiac arrhythmia.

- Have serious medical or psychiatric illness that could, in the Investigator's
opinion, potentially interfere with the completion of treatment according to this

- Must not have other invasive malignancies within the past 3 years (with the exception
of non-melanoma skin cancers or non-invasive bladder cancer).

- Is pregnant or breast-feeding, since the effects of NPC-1C on the developing human
fetus and nursing infants are unknown and potentially harmful, women of child-bearing
potential must agree to use adequate contraception (hormonal or double barrier method
of birth control or complete abstinence) prior to study entry, for the duration of
study participation, and for three months after the last dose of investigational

- Have had any chemotherapy or systemic corticosteroids within 2 weeks of study entry.

- Have acquired, hereditary or congenital immunodeficiencies including cellular
immunodeficiencies, hypogammaglobulinemia and dysgammaglobulinemia.

- Have a prior history of a documented hemolytic event.

- Have a history of hypersensitivity to human or mouse antibody products.

- Is HIV-positive receiving anti-retroviral therapy due to the possibility of
pharmacokinetic interactions between antiretroviral medications and NPC-1C. HIV
positive patients not receiving antiretroviral therapy are excluded due to the
possibility that Gemcitabine or NPC-1C may worsen their condition and the likelihood
that the underlying condition may obscure the attribution of adverse events with
respect to Gemcitabine or NPC-1C.

Type of Study:


Study Design:

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

Outcome Measure:

Safety and tolerability

Outcome Description:

To determine the safety and tolerability of NPC-1C monoclonal antibody therapy in combination with Gemcitabine in subjects with metastatic, locally advanced unresectable or recurrent pancreatic cancer who failed or did not tolerate first line chemotherapy of FOLFIRINOX and whose tumors bind NPC-1C.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Philip M Arlen, MD

Investigator Role:

Study Director

Investigator Affiliation:

Precision Biologics, Inc


United States: Food and Drug Administration

Study ID:




Start Date:

April 2013

Completion Date:

October 2015

Related Keywords:

  • Metastatic, Locally Advanced Unresectable or Recurrent Pancreatic Cancer.
  • Pancreatic neoplasms
  • Pancreatic cancer
  • Pancreatic cancer, adult
  • Adenoma of the pancreas
  • Carcinoma of the pancreas
  • Pancreatic Neoplasms



Montefiore Medical CenterBronx, New York  10467-2490
Duke UniversityDurham, North Carolina  27710
National Cancer InstituteBethesda, Maryland  20892-1922