Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Gemcitabine

Tyrosine Kinase Inhibitors

Vatalanib

Antimetabolites

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily

Gemcitabine 850 mg/m2 + vatalanib 1250 mg

Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter

Vatalanib 250 mg PO Q12 hours x 7 days, 8th day forward 500 mg PO Q12 hours

George Albert Fisher M.D. Ph.D.

The purpose of the study is to determine the optimal safe and tolerable dose of gemcitabine in combination with once daily or twice daily dose of PTK/ZK in patients with unresectable pancreatic cancer. The Phase II part of this study planned to determine the antitumor activity of this regimen and its effectiveness of preventing tumor growth and spread.

Phase 1-2 Vatalanib and Gemcitabine in Advanced Pancreatic Cancer

A Phase 1-2 Study of the VEGF Receptor Tyrosine Kinase Inhibitor PTK787/ZK 222584 <Vatalanib> and Gemcitabine in Patients With Advanced Pancreatic Cancer

For the purposes of an Intent-to-Treat (ITT) analysis, Time-to-Treatment Failure (TTF) was defined as the time from treatment initiation to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, lost-to-follow-up, or death.

Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).

Represents the evaluable subset of subjects that terminated from the study due to disease progression (endpoint). Does not include any other form of treatment failure, nor lost-to-follow-up.

Novartis

George Albert Fisher

Associate Professor of Medicine

Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily

Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12

Gemcitabine: 850 mg/m2

Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250

Gemcitabine 850 mg/m2 + vatalanib 1250 mg

Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12

Gemcitabine: 850 mg/m2

Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250

Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter

Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12

Gemcitabine: 850 mg/m2

Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500

Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily

Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12

Gemcitabine: 850 mg/m2

Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500

Total

Age, Continuous

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

33 adult patients with advanced pancreatic cancer

George Albert Fisher, Associate Professor of Medicine, Stanford University

Time-to-Treatment Failure (Intent-To-Treat Analysis)

Evaluable subset of subjects that terminated from the study due to disease progression (endpoint).

No participants were analyzed in the "Stage 1 Dose Exploration 2 - Gemcitabine 850 + Vatalanib 2 x 250 / 2 x 500 group" because no evaluable participants progressed within 12 months.

Spots Global Cancer Trial Database for Phase 1-2 Vatalanib and Gemcitabine in Advanced Pancreatic Cancer

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