Advanced Pancreatic Cancer Clinical Trial
Official title:
Phase II, Open Label Clinical Trial of Paricalcitol in Combination With Gemcitabine/ Nab-Paclitaxel Therapy in Advanced Pancreatic Cancer
Verified date | March 2024 |
Source | Cancer Trials Ireland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The trial is designed to establish whether adding a vitamin D analogue, Paricalcitol, to standard chemotherapy treatment, Gemcitabine and Nab-paclitaxel, can improve the outcomes for patients with advanced pancreatic cancer.
Status | Completed |
Enrollment | 15 |
Est. completion date | September 30, 2022 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Written informed consent obtained prior to any study-related procedures. 2. Incurable recurrent, locally advanced or metastatic pancreatic adenocarcinoma. 3. Histologically or cytologically confirmed pancreatic adenocarcinoma. 4. No prior chemotherapy for incurable, locally advanced unresectable or metastatic pancreatic cancer. Patients may have received prior chemotherapy in the neo-adjuvant or adjuvant setting provided they have a minimum treatment-free interval of 3 months. 5. At least one measurable lesion according to RECIST criteria (Version 1.1). Patients with bone only disease are not eligible. 6. Aged 18 years or older 7. ECOG performance status 0 - 2 8. Adequate haematological, renal and hepatic function measured within 28 days prior to commencing study: - Total bilirubin = ULN (or = 3 x ULN (= grade 2) for patients with liver involvement) - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 x ULN (= grade 1) (= 5 x ULN for patients with liver involvement by pancreatic cancer). - Glomerular filtration rate (GFR) = 30mL/min/1.73 m2 (= grade 2) for patients with serum creatinine levels above or below the institutional normal range. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (e.g., using the Cockroft-Gault formula). For patients with a Body Mass Index (BMI) >30 kg/m2, lean body weight should be used instead. - Platelet count = 100 x 109/L. - Haemoglobin (Hb) = 8 g/dL (= grade 2) - Absolute neutrophil count (ANC) = 1.5 x 109/L (= grade 1) - Corrected serum calcium of = 2.9 mmol/L (= grade 1). 9. Life expectancy of at least 12 weeks. 10. Women of childbearing potential and sexually active males must agree to use highly effective contraceptive measures. This applies from starting treatment until at least 6 months after the last study drug administration. The investigator or a designated associate is required to advise the patient how to achieve an adequate birth control. Highly effective contraception is defined in the study as methods that achieve a failure rate of less than 1% per year when used consistently and correctly. Such methods include: i. Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal). ii. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable and implantable). iii. Intrauterine device (IUD). iv. Intrauterine hormone-releasing system (IUS). v. Bilateral tubal occlusion. vi. Successfully vasectomised partner. vii. Sexual abstinence. Exclusion Criteria: 1. Treated with other investigational drugs within 28 days or 5.5 half-lives of treatment start; in addition, concurrent alternative (complementary) medications are excluded within 28 days of treatment start. 2. Known brain metastases, unless previously treated and well-controlled for at least 2 months. 3. Dementia, altered mental status, or any other psychiatric condition that would interfere with the patient's safety or informed consent 4. History of other malignancy other than pancreatic cancer. However, patients who have been disease free from another malignancy for at least 5 years, or patients with a history of resected non-melanoma skin cancer or successfully treated in situ cancer and superficial bladder tumours (Ta, Tis, T1) are eligible. 5. Known history of hypercalcaemia. 6. Presence or history of symptomatic kidney stones in the last 5 years. 7. Active, clinically serious infections > grade 2 (CTCAE v5.0). 8. Greater than or equal to grade 2 sensory or motor neuropathy 9. Uncontrolled intercurrent illness, including, but not limited to uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or social situation that would affect compliance with the requirements of this study. 10. GI tract disease resulting in an inability to take oral medications, malabsorption syndrome, where previous surgical procedures affect absorption and uncontrolled inflammatory bowel disease. 11. History of diseases known to be associated with calcium disorders, including: ongoing hyperparathyroidism and Sarcoidosis. 12. Hypersensitivity to any of the excipients of gemcitabine, Nab-paclitaxel or Paricalcitol. 13. Known vitamin D toxicity 14. Undergoing treatment with the following therapies and medications: 1. Concurrent use of drugs known to influence serum calcium such as thiazide diuretics, teriparatide (recombinant parathyroid hormone), calcitonin and multivitamin supplements containing > 400 IU of vitamin D or calcium. 2. Current use of drugs which could influence bioavailability of paricalcitol (such as magnesium-containing antacids, bile-resin binders). 3. Current use of strong inhibitors of CYP3A4 or CYP2C8. 4. Current use of inducers of CYP3A4 or CYP2C8. 5. Phosphate related medicinal products. Note: - Zoledronate or denosumab for patients with bone metastasis is allowed. Note patients with bone only disease are not eligible. - Calcium intake is not restricted, but calcium supplementation is not permitted. |
Country | Name | City | State |
---|---|---|---|
Ireland | Cork University Hospital | Cork | |
Ireland | Beaumont Hospital | Dublin | Dublin 9 |
Ireland | St. Vincent's University Hospital | Dublin | Dublin 4 |
Ireland | Tallaght University Hospital | Dublin | Dublin 24 |
Ireland | University Hospital Limerick | Limerick | |
Ireland | University Hospital Waterford | Waterford |
Lead Sponsor | Collaborator |
---|---|
Cancer Trials Ireland |
Ireland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety and tolerability | Incidence of adverse events reported and toxicity evaluation as per the NCI CTCAE version 5.0 | 18 months post last patient registered | |
Other | Incidence of hypercalcaemia | Incidence of hypercalcaemia | 18 months post last patient registered | |
Primary | Progression free survival | PFS is the percentage of patients free of progression at 24 weeks from registration into the study as determined by radiographic disease assessments per RECIST version 1.1. | 24 weeks from registration into the study | |
Primary | Overall survival (OS) | Overall survival (OS) | 18 months post last patient registered | |
Secondary | Time to treatment failure | Time to Treatment Failure (TTF) is defined as time from registration to discontinuation of therapy or add-on of new anti-cancer therapy for any reason (including death, progression and toxicity). | 18 months post last patient registered | |
Secondary | Tumour response rate Duration of response | Confirmed tumour response rate as assessed by RECIST criteria version 1.1. Duration of response (DR) as assessed by RECIST criteria version 1.1. | 18 months post last patient registered |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05028933 -
IMC001 for Clinical Research on Advanced Digestive System Malignancies
|
Phase 1 | |
Not yet recruiting |
NCT03662035 -
Apatinib Combined With S-1 in the Second-line Treatment of Advanced Pancreatic Cancer
|
Phase 2 | |
Recruiting |
NCT05085548 -
ProAgio in Previously Treated Advanced Pancreatic Cancer and Other Solid Tumor Malignancies
|
Phase 1 | |
Recruiting |
NCT06111274 -
A Phase 2 Study of ABSK021 in Patients With Advanced Pancreatic Cancer
|
Phase 2 | |
Active, not recruiting |
NCT04137536 -
A Study of Armed, Activated T-Cells in Patients With Advanced Pancreatic Cancer
|
Phase 1 | |
Active, not recruiting |
NCT04469556 -
Pancreatic Adenocarcinoma Signature Stratification for Treatment
|
Phase 2 | |
Recruiting |
NCT04104672 -
A Study to Evaluate the Safety and Tolerability of AB680 in Participants With Gastrointestinal Malignancies
|
Phase 1 | |
Not yet recruiting |
NCT05100329 -
A Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Advanced Pancreatic Cancer
|
Phase 2 | |
Completed |
NCT02101580 -
Ph 1B Trial With ADI-PEG 20 Plus Nab-Paclitaxel and Gemcitabine in Subjects With Pancreatic Cancer
|
Phase 1 | |
Not yet recruiting |
NCT06329947 -
A Phase II Study of Surufatinib Combined With Camrelizumab and mFOLFOX6 as Second-line Treatment for Advanced PRAD
|
Phase 2 | |
Recruiting |
NCT02135822 -
Nab-paclitaxel Plus Gemcitabine in Chinese Patients With Advanced Pancreatic Cancer
|
Phase 2 | |
Recruiting |
NCT04803851 -
Anlotinib Plus Anti-PD-1 Antibody AK105 for Advanced Pancreatic Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03415802 -
Efficacy and Safety of Nab-Paclitaxel Plus S-1 in the First-line Treatment of Advanced Pancreatic Cancer
|
Phase 2 | |
Recruiting |
NCT05162118 -
Clinical Study of VG161 in Combination With Nivolumab in Subjects With Advanced Pancreatic Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT04643405 -
APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma
|
Phase 1/Phase 2 | |
Recruiting |
NCT03889795 -
Phase IB Metformin, Digoxin, Simvastatin in Solid Tumors
|
Phase 1 | |
Completed |
NCT01303172 -
A Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer
|
Phase 2 | |
Not yet recruiting |
NCT06422156 -
SBRT Combined With Nimotuzumab and Mono-chemotherapy in Locally Advanced Pancreatic Cancer
|
Phase 2 | |
Recruiting |
NCT04931381 -
Organoid-Guided Chemotherapy for Advanced Pancreatic Cancer
|
Phase 3 | |
Recruiting |
NCT04482257 -
Bioequivalence Study of Irinotecan Liposome Injection in Chinese Advanced Pancreatic Cancer.
|
Phase 1 |