A PHASE I / II TRIAL OF WEEKLY ABI-007 PLUS GEMCITABINE IN PATIENTS WITH METASTIC PANCREATIC CANCER(10041120)

A PHASE I / II TRIAL OF WEEKLY ABI-007 PLUS GEMCITABINE IN PATIENTS WITH METASTIC PANCREATIC CANCER

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221942

Enrollment

Registered

2012-10-18

Start date

2012-10-18

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: -Patients must be diagnosed as invasive ductal carcinoma. -Patient must have received no previous therapy. -Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. -Written informed consent.

Exclusion criteria

Exclusion criteria: - Patient has pre-existing peripheral neuropathy or symptoms of peripheral sensory. - Patient has uncontrollable pain symptoms. - Patient has uncontrolled or severe diabetes. - Patient has complication or history of serious lung disease, serious heart disease, serious cerebrovascular disorder, or other serious diseases.

Design outcomes

Primary

Measure	Time frame
Phase I:tolerability, Phase II: Overall Response Rate Phase I: The primary objective of this study is to evaluate tolerability of the combination of ABI-007 and gemcitabine in patients with metastatic adenocarcinoma of the pancreas. Phase II: The primary objective of this study is to evaluate the objective tumor response in patients with metastatic adenocarcinoma of the pancreas according to RECIST guidelines (Overall Response Rate)	—

Measure

Time frame

Phase I:tolerability, Phase II: Overall Response Rate Phase I: The primary objective of this study is to evaluate tolerability of the combination of ABI-007 and gemcitabine in patients with metastatic adenocarcinoma of the pancreas. Phase II: The primary objective of this study is to evaluate the objective tumor response in patients with metastatic adenocarcinoma of the pancreas according to RECIST guidelines (Overall Response Rate)

—

Secondary

Measure	Time frame
Safety, Efficacy The secondary objectives are to evaluate adverse drug reactions and efficacy in patients with metastatic adenocarcinoma of the pancreas.	—

Outcome results

None listed

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