Phase I clinical study of ABI-007 in combination with gemcitabine

Phase I Clinical Study of ABI-007 in Combination with Gemcitabine as Adjuvant Chemotherapy in Patients with Resected Pancreatic Cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223124

Enrollment

Registered

2016-03-02

Start date

2016-06-13

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

pancreatic cancer

Interventions

investigational material(s) Generic name etc : ABI-007, Gemcitabine INN of investigational material : Paclitaxel, Gemcitabine Therapeutic category code : 42- Antineoplastic agents Dosage and Administr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Has personally given written informed consent to participate in this clinical study - Pancreatic adenocarcinoma histologically confirmed to be invasive ductal carcinoma - Macroscopic examination shows that the primary pancreatic lesion has been completely resected - Has undergone surgery for primary pancreatic tumor within 12 weeks before the start of study treatment - Pancreatic cancer staging: T1-3, N0-1 and M0 by TNM classification (the seventh edition, proposed by UICC in 2009)

Exclusion criteria

Exclusion criteria: - History of treatment other than surgery (chemotherapy, radiotherapy, etc.) for the primary pancreatic tumor - Grade 2 or higher peripheral sensory or motor neuropathy - As judged by the investigator (subinvestigator), ineligible for entry into the study

Design outcomes

Primary

Measure	Time frame
safety tolerability	—

Secondary

Measure	Time frame
safety efficacy other safety, treatment exposure and efficacy	—

Countries

Japan

Outcome results

None listed

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