EndoTAG®-1 and Gemcitabine Combination Therapy for the Treatment of Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN24531831

Enrollment

200

Registered

2006-03-02

Start date

2005-09-26

Completion date

Unknown

Last updated

2021-01-25

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

Conditions

Locally advanced and/or metastatic adenocarcinoma of the pancreas Cancer Locally advanced and/or metastatic adenocarcinoma of the pancreas

Interventions

Combination therapy of EndoTAG®-1 (lipid-complexed paclitaxel) and gemcitabine with three different doses of EndoTAG®-1 compared to gemcitabine monotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Inoperable adenocarcinoma of the pancreas 2. Histological confirmation 3. At least 18 years of age

Exclusion criteria

Exclusion criteria: 1. Any chemotherapeutical treatment for pancreatic adenocarcinoma before enrolment 2. Major surgery within four weeks prior to enrolment 3. Major cardiovascular disease

Design outcomes

Primary

Measure	Time frame
1. Median overall survival 2. Median time to progression 3. Response rate 4. Clinical benefit 5. Adverse events	—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026