Safety Feasibility and Effect of TTFields (150 kHz) Concomitant With Gemcitabine or Concomitant With Gemcitabine Plus Nab-paclitaxel for Front-line Therapy of Advanced Pancreatic Adenocarcinoma (PANOVA)

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is a prospective, double arm, non-randomized, open label pilot trial, designed to study the safety, feasibility and preliminary efficacy of a medical device, the NovoTTF-100L concomitant with gemcitabine or concomitant with gemcitabine plus nab-paclitaxel, for front-line therapy of pancreatic adenocarcinoma. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NovoCure Ltd.
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

1. Diagnosis of unresectable locally advanced or metastatic adenocarcinoma of the pancreas with histologically or cytologically confirmed disease.

2. 18 years of age and older

3. Life expectancy of at least 12 weeks

4. Measureable or assessable disease according to the revised RECIST criteria version 1.1.

5. ECOG (Eastern Cooperative Oncology Group) score 0-1

6. Adequate bone marrow, liver and kidney function:

1. Absolute neutrophil count ≥ 1.5 x 10^9/L

2. Platelet count ≥ 100 x 10^9/L

3. Hemoglobin ≥ 10 g/dL

4. AST and/or ALT ≤ 3 x upper limit of normal range (ULN) or ≤ 5 x ULN if patient has documented liver metastases

5. Bilirubin ≤1.5 x ULN

6. Serum creatinine ≤ 1.5 x ULN

7. Coagulation status: PT and PTT within normal limits or within therapeutic limits for patients receiving anticoagulation.

7. Able to operate the NovoTTF-100L System independently or with the help of a caregiver.

8. No concurrent anti-tumor therapy (beyond gemcitabine or gemcitabine and nab-paclitaxel and TTField therapy as per protocol).

9. No prior chemotherapy or radiation allowed.

10. At least 4 weeks since major surgery.

11. Prior surgery allowed for local disease provided a measurable lesion remains on the baseline CT scan.

12. Signed informed consent form

Exclusion Criteria:

1. Known brain metastases or meningeal carcinomatosis.

2. Any other malignancy requiring anti-tumor treatment in the past three years.

3. Significant comorbidity which is expected to affect patient's prognosis or ability to receive the combined therapy:

1. History of significant cardiovascular disease unless the disease is well controlled. Significant cardiac disease includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary activity results in fatigue, palpitation or dyspnea).

2. History of arrhythmia that is symptomatic or requires treatment. Patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the trial.

3. Active infection or any serious underlying medical condition that would impair the ability of the patient to receive protocol therapy.

4. History of any psychiatric condition that might impair the patient's ability to understand or comply with the requirements of the study or to provide consent.

4. Implantable electronic medical devices including pacemaker, implantable automatic defibrillator, etc.

5. Known allergies to medical adhesives or hydrogel or nab-paclitaxel.

6. Pregnant or breast feeding.

7. Admitted to an institution by administrative or court order