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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019588-12 | EudraCT Number |
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Open-label, uncontrolled, Phase I/II study to evaluate safety and efficacy of BAY86-9766 plus gemcitabine in locally advanced, unresectable or metastatic pancreatic cancer.
Phase I: Dose escalation study investigating 20, 30 and 50 mg BAY86-9766 plus gemcitabine (1000mg/m2); determination of maximum tolerated dose and recommended phase 2 dose.
Phase II: Determination of response (RECIST 1.1; primary endpoint). Secondary endpoints: response duration, disease control rate, time to progression, progression-free survival, overall survival, safety and tolerability.
Tumor assessments at Screening and than every 8 weeks.; Safety evaluations at Screening and weekly throughout the study; Safety follow-up visit 30 days after the last dose of study treatment; Survival follow up monthly for up to 8 month after LPFV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY86-9766+Gemcitabine | Drug | Phase I: 40 mg/day (20 mg twice daily), 60 mg/day (30 mg twice daily, 100 mg/day (50 mg bid) dependent on safety/tolerability Phase II: Recommended Phase II dose (RP2D) dependent on the results of the Phase I part of this study Route of administration: Oral, twice daily (bid) in combination with gemcitabine 1000 mg/m2 Intravenous infusion over 30 minutes weekly for seven out of eight weeks (Cycle 1); followed by 1000 mg/m2 Intravenous infusion over 30 minutes weekly for three out of four weeks (Cycle 2 and subsequent) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Dose Limiting Toxicities (DLT): Phase I | From randomization up to the first 8 weeks of therapy | |
| Tumor Response (Adjudicated Blinded Read Assessment): Phase II | From start of treatment until 134 weeks assessed every 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response: Investigator Assessment: Phase I | From start of treatment until 134 weeks assessed every 8 weeks | |
| Disease Control (DC): Phase I | From start of treatment until 134 weeks assessed every 8 weeks |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aurora | Colorado | 80045 | United States | |||
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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| Disease Control (DC): Phase II | From start of treatment until 134 weeks assessed every 8 weeks |
| Duration of Response (DOR): Phase I | From start of treatment until 134 weeks assessed every 8 weeks |
| Duration of Response: Phase II | From start of treatment until 134 weeks assessed every 8 weeks |
| Time to Progression (TTP): Phase I | From start of treatment until 134 weeks assessed every 8 weeks |
| Time to Progression (TTP): Phase II | From start of treatment until 134 weeks assessed every 8 weeks |
| Progression-Free Survival (PFS): Phase I | From start of treatment until 134 weeks assessed every 8 weeks |
| Progression-Free Survival (PFS): Phase II | From start of treatment until 134 weeks assessed every 8 weeks |
| Overall Survival (OS): Phase I | From start of treatment until 134 weeks assessed every 8 weeks |
| Overall Survival (OS): Phase II | From start of treatment until 134 weeks assessed every 8 weeks |
| Pittsfield |
| Massachusetts |
| 01201 |
| United States |
| Bruxelles - Brussel | 1070 | Belgium |
| Bruxelles - Brussel | 1090 | Belgium |
| Edegem | 2650 | Belgium |
| Brno | 602 00 | Czechia |
| Olomouc | 775 20 | Czechia |
| Clermont-Ferrand | 63003 | France |
| Heilbronn | Baden-Wurttemberg | 74078 | Germany |
| München | Bavaria | 81377 | Germany |
| Marburg | Hesse | 35033 | Germany |
| Bochum | North Rhine-Westphalia | 44892 | Germany |
| Berlin | 13353 | Germany |
| Brescia | Lombardy | 25124 | Italy |
| Ancona | The Marches | 60126 | Italy |
| Oslo | 0310 | Norway |
| Oslo | Norway |
| Bialystok | 15-027 | Poland |
| Gdansk | 80-952 | Poland |
| Warsaw | 02-781 | Poland |
| London | SE1 9RT | United Kingdom |
| London | WC1E 6BT | United Kingdom |
| London | United Kingdom |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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