Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Combination Therapy With NC-6004 and Gemcitabine Versus Gemcitabine Alone in Pancreatic Cancer

Summary: This clinical trial is designed to evaluate the impact of the addition of NC-6004 to gemcitabine in the treatment of patients with locally advanced or metastatic pancreatic cancer in Asian countires.

Detailed description: Pancreatic cancer is one of the most deadly cancers because of the predominately late diagnosis. Gemcitabine (GEM) is the standard treatment for advanced and metastatic pancreatic cancer. According to preclinical data and few early phase studies, a combined use of gemcitabine and cisplatin (CDDP) showed synergistic efficacy against pancreatic cancer. NC-6004, a novel micellar cisplatin formulation, retains the activity but avoids the renal toxicity and neurotoxicity caused by the high peak Cmax concentrations of cisplatin. This trial is designed to evaluate the impact of the addition of NC-6004 to gemcitabine in the treatment of patients with locally advanced or metastatic pancreatic cancer.
  The main hypothesis of this study is that NC-6004 plus gemcitabine combination is superior to gemcitabine alone in terms of overall survival in locally advanced or metastatic pancreatic cancer patients

Eligibility: Inclusion Criteria:
  1. Male or female aged between 20 to 80 years (inclusive)
  2. Unresectable, histologically or cytologically confirmed, locally advanced or metastatic pancreatic cancer (adenocarcinoma, adenosquamous carcinoma or poorly differentiated carcinoma)
  3. Presence of at least one measurable tumor lesion (longest diameter ≥ 10 mm)
  4. No prior systemic anti-cancer therapy and radiotherapy for advanced pancreatic cancer
  5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  6. Adequate organ function defined as:
  -  3,000 cells/μL ≤ White blood cell count (WBC) ≤ 12,000 cells/μL
  -  Absolute neutrophils count (ANC) ≥ 1,500 cells/μL
  -  Platelets ≥ 100,000 cells/μL
  -  Hemoglobin (Hb) ≥ 9.0 g/dL
  -  Alanine amino transferase (ALT) and aspartate amino transferase (AST) ≤ 2.5 times the upper limit of normal (ULN) in patients with no demonstrable hepatic metastasis, or ≤ 5 x ULN in patients with hepatic metastasis
  -  Serum bilirubin ≤ 1.5 x ULN in patients with no demonstrable hepatic metastasis and obstructive jaundice, or ≤ 2.5 x ULN in patients with hepatic metastasis or obstructive jaundice
  -  Serum creatinine (SCr) ≤ 1.5 mg/dL and creatinine clearance (CrCl) ≥ 60 mL/min (from 24-hour urine test or Cockcroft-Gault formula)
  -  Corrected serum calcium ≤ ULN
  7. If fertile, willing to use barrier contraception till 6 months after the end of treatment
  8. Willing and able to comply with study procedures and provide written informed consent
  Exclusion Criteria:
  1. Pregnancy or breastfeeding
  2. Active concomitant malignancy or history of other cancer except carcinoma in situ of cervical squamous cell carcinoma, stage I colon cancer or other malignance that has remained disease-free for more than 3 years after curative intervention
  3. Metastasis to the central nervous system or brain
  4. Evidence of hearing impaired ≥ Grade 2 as assessed by pure tone audiometry or other neurotoxicity ≥ Grade 2
  5. Pulmonary fibrosis or interstitial pneumonia
  6. Marked pleural effusion or ascites above Grade 2
  7. Patient with known HIV infection
  8. Patient with active hepatitis B, hepatitis C or any other ongoing severe infections
  9. Severe mental disorder
  10. As judged by the investigator, any evidence of significant laboratory findings or severe/uncontrolled clinical disorders (e.g. dementia, myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) Class III or IV heart failure, unstable angina, active cardiomyopathy, unstable arrhythmia, and other unstable or uncompensated respiratory, cardiac, hepatic, renal and/or infectious disease)
  11. Patient with known hypersensitivity to Pt compounds
  12. Known severe drug hypersensitivity
  13. Treatment with a non-approved or investigational product within 30 days before Day 1 of study treatment

Relevance to patient case: not relevant