Pancreatic Cancer, Adult Clinical Trial
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
Verified date | December 2019 |
Source | Precision Biologics, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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). |
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 |
Lead Sponsor | Collaborator |
---|---|
Precision Biologics, Inc |
United States,
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 |
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