Study of MEDI4736, when used alone or in combination with Tremelimumab, as second line chemotherapy in metastatic Pancreatic Ductal Adenocarcinoma

Phase 1

• Conditions: Adult patients (aged =18 years) with histologically or cytologically confirmed metastatic PDAC, and had tumor progression following prior standard first-line 5-FU-containing or gemcitabine-containing chemotherapy.; MedDRA version: 18.0Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-002001-11-DE
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-28
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

1.Histologically or cytologically confirmed metastatic PDAC, no more than 1 prior chemotherapy regimen
2. ECOG 0 or 1
3. At least 1 lesion, not previously irradiated, that can be accurately measured at
baseline as =10 mm in the longest diameter (except lymph nodes, which must have short axis =15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) scan and that is suitable for accurate repeated measurements
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 91
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 39

Exclusion Criteria

1.Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer
treatment.
2. History of leptomeningeal carcinomatosis
3. Ascites requiring intervention
4. Brain metastases or spinal cord compression.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified