Stage IV Pancreatic Cancer Clinical Trial
Official title:
Safety and Immunologic Activity of Multiple Infusions of APN401
Verified date | November 2021 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase I trial studies the side effects and best dose of APN401 in treating patients with pancreatic cancer, colorectal cancer, or other solid tumors that have spread to other places in the body or have come back. APN401 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Status | Completed |
Enrollment | 11 |
Est. completion date | December 8, 2020 |
Est. primary completion date | July 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with histologically confirmed inoperable, recurrent or metastatic malignant solid tumors, deemed incurable, and who have either: - Failed to respond to standard therapy or - For whom no standard therapy is available or - Refuse to receive standard therapies - The study is intended to enroll patients with pancreatic and colorectal cancer; patients with other types of solid tumors will require approval by the principal investigator - Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) - Patients with treated, stable, and asymptomatic brain metastases are eligible - Patients on every 3 or every 4 week systemic therapy programs must be at least 4 weeks since treatment and recovered from any clinically significant toxicity experienced; patients on weekly or daily systemic therapy programs and patients receiving radiation must be at least 1 week since treatment and recovered from any clinically significant toxicity experienced; must be at least 4 weeks and have recovered from major surgery - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - White blood cells >= 3000/uL - Platelets >= 100,000/uL - Hematocrit >= 28% - Creatinine =< 1.6 mg/dL - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x upper limit of normal - Bilirubin =< 1.6 mg/dL (except patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL) - Albumin >= 3.0 g/dL - International normalized ratio (INR) =< 1.5 Exclusion Criteria: - Women must not be pregnant or breastfeeding; all women of childbearing potential must have a blood test within 72 hours to rule out pregnancy; women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception; women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for 26 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized; sexually mature females who have not undergone a hysterectomy or who have not been postmenopausal naturally for at least 24 consecutive months (i.e., who have had menses at some time in the preceding 24 consecutive months) are considered to be of childbearing potential; women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential - Untreated, progressing, or symptomatic brain metastases - Autoimmune disease, as follows: patients with a history of inflammatory bowel disease are excluded as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's granulomatosis]); patients with motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis) are excluded; patients with a history of autoimmune thyroiditis are eligible if their current thyroid disorder is treated and stable with replacement or other medical therapy - Any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix - Other ongoing systemic therapy for cancer, including any other experimental treatment; these include concomitant therapy with any of the following: IL-2, interferon, ipilimumab, pembrolizumab, nivolumab, or other immunotherapy; cytotoxic chemotherapy; and targeted therapies - Ongoing requirement for an immunosuppressive treatment, including the use of glucocorticoids or cyclosporine, or with a history of chronic use of any such medication within the last 4 weeks before enrollment; patients are excluded if they have any concurrent medical condition that requires the use of systemic steroids (the use of inhaled or topical steroids is permitted) - Infection with human immunodeficiency virus (HIV) - Active infection with hepatitis B; active or chronic infection with hepatitis C - Clinically significant pulmonary dysfunction, as determined by medical history and physical examination; patients with a history of pulmonary dysfunction must have pulmonary function tests with a forced expiratory volume in 1 second (FEV1) >= 60% of predicted and a diffusing capacity of the lung for carbon monoxide (DLCO) >= 55% (corrected for hemoglobin) - Clinically significant cardiovascular abnormalities (e.g., congestive heart failure or symptoms of coronary artery disease), as determined by medical history and physical examination; patients with a history of cardiac disease must have a normal cardiac stress test (treadmill, echocardiogram, or myocardial perfusion scan) within the past 6 months of study entry - Active infections or oral temperature > 38.2 degrees Celsius (C) within 48 hours of study entry - Systemic infection requiring chronic maintenance or suppressive therapy - Patients are excluded for any underlying medical or psychiatric condition, which in the opinion of the investigator, will make treatment hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent rashes or diarrhea |
Country | Name | City | State |
---|---|---|---|
United States | Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of adverse events Common Terminology Criteria for Adverse Events version 4.0 | Will be categorized by organ system and severity, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events | Up to 1 year | |
Secondary | Clinical response as assessed by RECIST | Will be summarized as frequency counts and percentages. | Up to 5 years | |
Secondary | Immune response as measured by frequency of immune cells | Will be summarized as medians and ranges. The effects of treatment will be analyzed using paired t-tests or the non-parametric counterpart. | Up to 1 year | |
Secondary | Immune response as measured by interferon production | Will be summarized as medians and ranges. The effects of treatment will be analyzed using paired t-tests or the non-parametric counterpart. | Up to 1 year | |
Secondary | Immune response as measured by neutrophil to lymphocyte ratio | Will be summarized as medians and ranges. The effects of treatment will be analyzed using paired t-tests or the non-parametric counterpart. | Up to 1 year | |
Secondary | Overall survival (OS) | Exploratory survival plots will be estimated using the Kaplan Meier approach and median OS will be estimated if enough events occur. | From the initial infusion to confirmation of progression or death, assessed up to 5 years | |
Secondary | Progression-free survival (PFS) | Exploratory survival plots will be estimated using the Kaplan Meier approach and median PFS will be estimated if enough events occur. | From the initial infusion to confirmation of progression or death, assessed up to 5 years | |
Secondary | Survival as assessed by RECIST | Will be summarized as frequency counts and percentages. | Up to 5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT02495896 -
Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
Completed |
NCT02005315 -
A Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in Previously Untreated Stage IV Pancreatic Cancer
|
Phase 1 | |
Completed |
NCT01453153 -
Study of Gemcitabine + PEGPH20 vs Gemcitabine Alone in Stage IV Previously Untreated Pancreatic Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT01064622 -
Gemcitabine Hydrochloride With or Without Vismodegib in Treating Patients With Recurrent or Metastatic Pancreatic Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT00095966 -
Sorafenib and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
|
Phase 2 | |
Completed |
NCT02178436 -
Gemcitabine, Nab-paclitaxel and KPT-330 in Advanced Pancreatic Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT01846520 -
Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers
|
N/A | |
Completed |
NCT01647828 -
A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer
|
Phase 1/Phase 2 | |
Terminated |
NCT01555489 -
Assessing the Efficacy and Safety of IV Vitamin C in Combination With Standard Chemotherapy for Pancreatic Ca
|
Phase 2 | |
Completed |
NCT01191684 -
Vaccine Therapy in Treating Patients With Colorectal, Stomach, or Pancreatic Cancer
|
Phase 1 | |
Completed |
NCT01232829 -
Gamma Secretase Inhibitor RO4929097 in Previously Treated Metastatic Pancreas Cancer
|
Phase 2 | |
Terminated |
NCT01233505 -
Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT00735917 -
Saracatinib in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
|
Phase 2 | |
Completed |
NCT02896907 -
Ascorbic Acid and Combination Chemotherapy in Treating Patients With Locally Advanced or Recurrent Pancreatic Cancer That Cannot Be Removed by Surgery
|
Early Phase 1 | |
Completed |
NCT02307539 -
Palliative Care in Improving Quality of Life in Patients With Newly Diagnosed Pancreatic Cancer
|
N/A | |
Completed |
NCT02050178 -
Dose Escalation Study of OMP-54F28 in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Previously Untreated Stage IV Pancreatic Cancer
|
Phase 1 | |
Completed |
NCT01488552 -
Gemcitabine+Nab-paclitaxel and FOLFIRINOX and Molecular Profiling for Patients With Advanced Pancreatic Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT01222689 -
Selumetinib and Erlotinib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
|
Phase 2 | |
Completed |
NCT00397787 -
Sunitinib in Treating Patients With Metastatic Pancreatic Cancer That Progressed After First-Line Therapy With Gemcitabine
|
Phase 2 | |
Completed |
NCT00028496 -
Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer
|
Phase 1 |