Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01834235
Other study ID # PB1201
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date April 2013
Est. completion date December 2019

Study information

Verified date December 2019
Source Precision Biologics, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Terminated
Enrollment 81
Est. completion date December 2019
Est. primary completion date March 13, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
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 known brain metastases.

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

- Have greater than grade 2 ascites at time of enrollment.

- 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).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Gemcitabine
Gemcitabine IV at a dose of 1000mg/m2 on days 1, 8, and 15 of a 4 week cycle.
nab-paclitaxel
Nab-paclitaxel will be administered at a dose of 125 mg/m2 as a 30 minute infusion (maximum infusion time not to exceed 40 minutes) on Days 1, 7 and 15 for a 28 day cycle
NPC-1C
NPC-1C(NEO-102) infusion at a dose of 1.5mg/kg IV on days 1 and 15 of a 28 day cycle. This will be administered 30 minutes after completion of the gemcitabine infusion.

Locations

Country Name City State
United States National Cancer Institute Bethesda Maryland
United States Beht Isreal Deaconess Medical Center Boston Massachusetts
United States Dana Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States UT Southwestern Medical Center Dallas Texas
United States Duke University Durham North Carolina
United States University of Miami Miami Florida
United States Smilow Cancer Hospital- Yale New Haven Connecticut
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States Washington University in St. Louis Saint Louis Missouri
United States California Pacific Medical Center San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Precision Biologics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and tolerability 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. 12 months
Primary Overall Survival To determine whether NPC-1C (NEO-102) in combination with Gemcitabine and nab-Paclitaxel will increase the overall survival (OS) compared to Gemcitabine and nab-Paclitaxel alone in patients with metastatic, locally advanced unresectable or recurrent pancreatic cancer previously treated with FOLFIRINOX and whose tumors bind NPC-1C by at least 20% on IHC. 8 months
Secondary Progression Free Survival To determine the progression free survival (PFS) and response rate (RR) of patients with metastatic or locally advanced unresectable or recurrent pancreatic cancer who progressed following or did not tolerate chemotherapy of FOLFIRINOX or FOLFIRINOX-like regimen when receiving the combination of NPC-1C(NEO-102) monoclonal antibody, Gemcitabine and nab-Paclitaxel. 8 months
Secondary Immunologic Correlates To explore the immunologic correlates associated with the administration of NPC-1C monoclonal antibody therapy in combination with Gemcitabine. 24 Months
See also
  Status Clinical Trial Phase
Recruiting NCT06388967 - Pancreatic Cancer Detection Consortium
Recruiting NCT03977233 - Tumor Subtypes in Subjects on FOLFIRINOX With Non-Metastatic Pancreatic Cancer Phase 2
Recruiting NCT05006131 - Pancreatic Cancer Screening for At-risk Individuals
Completed NCT04002128 - Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery N/A
Recruiting NCT03854110 - Trial to Evaluate Safety and Tolerability of GP-2250 in Combination With Gemcitabine Phase 1
Recruiting NCT04136522 - Usefulness of the Artery First Approach in Pancreatic Cancer Surgery N/A
Completed NCT03042442 - Relation Between Cachexia, Diabetes and periNeural Invasion in PANcreatic Cancer- Biomarkers Substudy
Completed NCT03152487 - Trial Comparing EUS-guided Radiofrequency Ablation vs. EUS-guided Celiac Plexus Neurolysis N/A