STEMNESS-PANC (JCP148)
- JGH CRP
- Nov 8, 2024
- 3 min read
A Phase II/III Randomized, Open-Label Clinical Study of Napabucasin in Combination with Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Metastatic Pancreatic Cancer Following Chemotherapy Failure
Population: Pancreatic cancer, metastatic
Line of therapy: 2L+
Intervention: Napabucasin (GB201) in Combination with Weekly Paclitaxel and Low-dose Gemcitabine
Key Inclusion Criteria
Histologically or cytologically confirmed advanced pancreatic adenocarcinoma that is metastatic. Patients with islet cell neoplasms and rare subtypes of pancreatic adenocarcinoma are excluded.
Must have failed at least one line of chemotherapy, including but not limited to: • A gemcitabine-containing regimen (i.e. single-agent or in combination) • FOLFIRINOX or mFOLFIRINOX
Patients who relapsed during or within 6 months of last dose of the regimens listed above in the adjuvant or neoadjuvant setting may be enrolled
One or more metastatic tumors evaluable by CT scan with contrast (or MRI, if patient is allergic to CT contrast media) per RECIST 1.1.
ECOG Performance Status of 0 or 1, assessed within 14 days prior to randomization.
Must have life-expectancy of > 12 weeks.
Patient has adequate biological parameters as demonstrated by blood counts at baseline
Acceptable coagulation studies
No clinically significant abnormalities on urinalysis results (obtained ≤ 14 days prior to randomization.
Adequate nutritional status with Body Mass Index (BMI) ≥ 18 kg/m2 and body weight of ≥ 40 kg with serum albumin ≥ 3 g/dL.
Patients requiring biliary stent placement must have biliary stent placed ≥ 7 days prior to screening.
Pain symptoms should be stable (of tolerable Grade 2 or less).
Only patients with available archival tumor tissue must consent to provision of, and Investigator(s) must confirm access to and agree to submit a representative formalin fixed paraffin block of tumor tissue in order that the specific correlative marker assays proscribed in this protocol may be conducted.
Key Exclusion Criteria
Anti-cancer chemotherapy, radiotherapy, biologic therapy or immunotherapy/immunomodulating treatment (for non-cancer related treatment) administered two weeks prior to the first planned dose of study medication. Investigational agents administered within four weeks of first planned dose of study medication. An exception is made for oral fluoropyrimidines (e.g. capecitabine, S-1), where a minimum of 10 days since last dose must be observed prior to the first planned dose of study medication.
Unresolved lingering toxicity > Grade 2 from prior treatment will be excluded.
Patients received prior chemotherapy only in the adjuvant or neoadjuvant setting, with progression occurring > 6 months of completion of therapy or resection with curative intent, respectively.
Intolerant to prior taxane treatment.
Decline in ECOG performance status between baseline visit and within 3 days prior to randomization.
≥ 20% decrease in serum albumin level between baseline visit and within 3 days prior to randomization.
≥ 10% decrease in weight between baseline visit and within 3 days prior to randomization.
Major surgery within 4 weeks prior to randomization.
Patients with any known brain or leptomeningeal metastases are excluded, even if treated.
Patients with clinically significant pleural effusion or ascites.
Patients with gastrointestinal disorder(s) which could significantly impede the absorption of an oral agent.
Patient who has smoked cigarettes/tobacco within 28 days prior to randomization or plan to use these products while on study treatment
Uncontrolled inter-current illness.
Known hypersensitivity to gemcitabine, taxanes or any of their excipients.
Neurosensory neuropathy ≥ grade 2 at baseline.
Uncontrolled chronic diarrhea ≥ grade 2 at baseline.
Patients being treated with any coumarins.
Sponsor: 1Globe Health Institute
CRP Contact: rhythm.sharma@ladydavis.ca
CRP PI: Dr. P. Kavan
Status: Open to accrual