Safety and Effectiveness Study of CPI-613 and/or Gemcitabine to Treat Metastatic Pancreatic Cancer

Browse trials for

• Adenocarcinoma 2,004

Keywords

• metastatic
• pancreatic
• adenocarcinoma
• cancer

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

Lead sponsor

Cornerstone Pharmaceuticals is the lead sponsor of 10 studies on the registry; none are open to participants now.

Study arms

• Experimental
  CPI-613 Alone

  This arm is for patients that have failed, or are not eligible for, all available therapies INCLUDING gemcitabine-based therapies. CPI-613 drug product, provided in concentrated form at 50 mg/mL, must be diluted with D5W prior to administration. CPI-613 is to be infused intravenously (IV) via a central venous catheter. CPI-613 will be given 2x weekly, administered on Days 1 and 4 of each of the 3 treatment weeks, followed by a week of rest. The dose of CPI-613 will be 3,000 mg/m2 infused IV over 2 hours (this is approximate maximum tolerated dosing \[MTD\]), via a central venous catheter with D5W running at a rate of about 125-150 mL/hr.

  Drug: CPI-613

• Active comparator
  Any non-gemcitabine chemotherapies or best supportive care

  This arm is for patients that have failed, or are not eligible for, all available therapies INCLUDING gemcitabine-based therapies. This arm includes any best-practice standard-of-care chemotherapies deemed appropriate by the clinical investigators, including the option for supportive care, following good clinical practice.

  Drug: Any non-gemcitabine chemotherapies or best supportive care

• Experimental
  Gemcitabine + CPI-613 in combination

  This arm is for patients who have failed, or are not eligible for, all available therapies EXCEPT gemcitabine-based therapies. When gemcitabine and CPI-613 are administered in combination, gemcitabine will be administered via 30-minute intravenous (IV) infusion at a concentration of 1,000 mg/m2 once-a-week on Day 1 for 3 consecutive weeks, followed by a week-of-rest. CPI-613 will be infused twice a week, administered on Days 1 and 4 for 3 consecutive weeks, followed by a week-of-rest, the same as gemcitabine. The dose of CPI-613 will be 710 mg/m2 infused IV over 2-hours (this is approximate maximum tolerated dosing \[MTD\] found from Phase I studies in combination with gemcitabine). To note, the dose of CPI-613 may be increased from 710 mg/m2 if ongoing Phase I trial data shows that the MTD of CPI-613 is higher than 710 mg/m2 CPI-613, diluted with D5W.

  Drug: CPI-613 · Drug: Gemcitabine

• Experimental
  Gemcitabine alone or in combination with therapeutic agent(s)

  This arm is for patients who have failed, or are not eligible for, all available therapies EXCEPT gemcitabine-based therapies. Gemcitabine, or Gemcitabine-based, chemotherapy will be administered via 30-minute intravenous (IV) infusion at a concentration of 1,000 mg/m2 once-a-week on Day 1 for 3 consecutive weeks, followed by a week-of-rest. This arm includes any best-practice standard-of-care Gemcitabine-based chemotherapies deemed appropriate by the clinical investigators following good clinical practice.

  Drug: Gemcitabine

Interventions

• DrugCPI-613

  CPI-613 drug product, provided in concentrated form at 50 mg/mL, must be diluted with D5W prior to administration. CPI-613 is to be infused intravenously (IV) via a central venous catheter. CPI-613 will be given 2x weekly, administered on Days 1 and 4 of each of the 3 treatment weeks, followed by a week of rest. The dose of CPI-613 will be 3,000 mg/m2 infused IV over 2 hours (this is approximate maximum tolerated dosing \[MTD\]), via a central venous catheter with D5W running at a rate of about 125-150 mL/hr.

  Also known as: 6,8-bis-benzylsulfanyloctanoic acid, 6,8-bis(benzylthio)octanoic acid, 6,8-bis-benzylsulfonyloctanoic acid, Bylantra

• DrugGemcitabine

  Also known as: 2´-deoxy-2´,2´-difluorocytidine monohydrochloride (beta-isomer), 4-amino-1-(2-deoxy-2,2-difluoro-β-D-erythro-pentofuranosyl)pyrimidin-2(1H)-on, Gemcitabine HCl, Gemzar

• DrugAny non-gemcitabine chemotherapies or best supportive care

Primary outcomes

1. Overall Survival (OS)

   Time frame: Monitored until participants pass away, for an expected average of 6 months.

Secondary outcomes

1. Changes in CA 19-9

   CA 19-9 is monitored through blood work ≤2 weeks before treatment and after every third cycle (12 weeks) of treatment while on-study. CA 19-9 is a pancreatic tumor biomarker and a decline in CA 19-9 during and after therapy may be a marker of treatment efficacy.

   Time frame: Monitored within 2-weeks before treatment, and every 3-cycles (months) during treatment

2. Quality of Life (QOL)

   QOL will be assessed as described by Aaronson NK, et al. 1993. It assesses how the various treatments and the disease affect the daily living abilities of the patient.

   Time frame: Monitored before, during, and 1-week after treatment with CPI-613, for an expected average of 20 weeks.

3. Progression-Free Survival (PFS)

   Time frame: Monitored during treatment with CPI-613 and until participants passed away, which will be an expected average of 6 months.

4. Safety

   Safety assessment will be based on clinical signs, vital signs, blood work, adverse events (AEs), serious adverse events (SAEs), etc.

   Time frame: Monitored just before study treatment, and during study treatment at the end of every 4-week treatment cycle, for an expected average of 20 weeks.