A Study of Gemcitabine and Nab-paclitaxel With or Without NPC-1C to Treat Patients With Pancreatic Cancer

Study ID
PB1201

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact


Principal Investigator

Official Title

A Multicenter Phase I/II Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel With or Without NPC-1C in Patients With Metastatic or Locally Advanced Pancreatic Cancer Previously Treated With FOLFIRINOX

Brief Overview


This is a randomized phase II multi-institution prospective open label study in which up to
90 subjects with metastatic, locally advanced unresectable or recurrent pancreatic cancer
who previously received treatment with chemotherapy with FOLFIRINOX or FOLFIRINOX-like
regimen will be enrolled into one of two arms:

A: NPC-1C with gemcitabine and nab-paclitaxel or B: gemcitabine and nab-paclitaxel

Summary


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 90 patients be
randomized to one of two arms:

A: Patients will receive NPC-1C(NEO-102) infusion at a dose of 1.5mg/kg IV nab-paclitaxel
(125 mg/m2 as a 30 minute infusion, maximum infusion time not to exceed 40 minutes) followed
by gemcitabine (1000 mg/m2 as a 30 minute infusion) for 3 consecutive weeks (on Day 1, 7 and
15 ) followed by a week of rest (for a 28 day cycle).

OR B: Patients will receive on Day 1, 7 and 15 nab-paclitaxel (125 mg/m2 as a 30 minute
infusion, maximum infusion time not to exceed 40 minutes) followed by gemcitabine (1000
mg/m2 as a 30 minute infusion) for 3 consecutive weeks (on Day 1, 7 and 15).
NPC-1C(NEO-102) infusion at a dose of 1.5mg/kg IV 30 minutes following the completion of
the gemcitabine on days 1 and 15 of the 28 day cycle.

Participant Eligibility


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
NPC-1C.

- 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 8 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
therapy)

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. Prior adjuvant/neoadjuvant gemcitabine or
gemcitabine-based radiation will not be counted as first line therapy.

- 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
protocol.

- 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
agent.

- 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.

- Have a known history of HIV are excluded due to the possibility that Gemcitabine or
NPC-1C(NEO-102) 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(NEO-102).