Gemcitabine and MK615 combination therapy in unresected advanced pancreatic cancer.: A pilot study

Gemcitabine and MK615 combination therapy in unresected advanced pancreatic cancer.: A pilot study - Gemcitabine and MK615 combination therapy in unresected advanced pancreatic cancer.: A pilot study

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025844

Enrollment

Registered

2017-01-25

Start date

2017-01-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

unresected advanced pancreatic cancer

Interventions

Gemcitabine 1000 mg/m2 IV one time over 30 minutes. Weekly dosing on Days 1, 8, and 15 of 28 day cycles. If severe toxicity occurs, a dose should be reduced (1000mg, 800mg, 600mg). MK615 MK615 w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histopathologically confirmed pancreatic cancer(adenocarcinoma and adenosquamous carcinoma) 2) Not resectable metastatic pancreatic cancer and No prior Gemcitabine-containing chemotherapy 3) ECOG performance status of 0, 1 or 2 4) 20<= years old 5) Expected survival period is more than 3 months 6) The organ function must be kept within 14 days before registration 6-1 leukocyte >= 3,000/mcL 6-2 neutrophil >=1,500/mcL 6-3 platelet >=75,000/mcL 6-4 hemoglobin >=8.0 g/dL. 6-5 T-Bilirubin >=2.0 mg/dL 6-6 AST =<100 IU/L (AST =<300 IU/L with liver metastasis) 6-7 ALT =<100 IU/L (ALT =<300 IU/L with liver metastasis) 6-8 serum creatinine =<2.5 mg/dL 7) written informed consent got from the patient

Exclusion criteria

Exclusion criteria: 1) Active concomitant malignancy or history of another malignancy within the last 5years 2) Symptomatic brain metastasis 3) Severe infectious diseases 4) Subjects with the past history of Interstitial pneumonia or pulmonary fibrosis 5) Subjects with the past history of severe heart disease 6) Severe Paresthesia or Sensory disorder with motor dysfunction 7) Severe pleural effusion, ascites, or pericardial effusion 8) Subjects with the past history of severe diseases (kidney disease,liver disease, heart disease). 9) History of Radiation therapy for pancrearic cancer 10) Men/Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test 11) Inappropriate to be enrolled in this study judged by the investigators

Design outcomes

Primary

Measure	Time frame
Safety: AEs	—

Countries

Japan

Contacts

Public ContactIchiro Moriyama

Shimane University Hospital Hematology/Oncology

ichimori@med.shimane-u.ac.jp0853-23-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026