BAGPAC: Combination With Gemcitabine in Advanced Pancreatic Cancer

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01251640
• Collaborator: (none)
• Enrollment: 90
• Locations: 23
• Arm: 1
• Actual Duration (Months): 31
• Patients Per Site: 3.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Neoplasms	Drug: BAY86-9766+Gemcitabine	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multi-center, Phase I/II Study of BAY86-9766 in Combination With Gemcitabine in Patients With Locally Advanced Inoperable or Metastatic Pancreatic Cancer
• Actual Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Feb 11, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: BAY86-9766+Gemcitabine; 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)

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With Dose Limiting Toxicities (DLT): Phase I [From randomization up to the first 8 weeks of therapy]

2. Tumor Response (Adjudicated Blinded Read Assessment): Phase II [From start of treatment until 134 weeks assessed every 8 weeks]

Secondary Outcome Measures

1. Tumor Response: Investigator Assessment: Phase I [From start of treatment until 134 weeks assessed every 8 weeks]

2. Disease Control (DC): Phase I [From start of treatment until 134 weeks assessed every 8 weeks]

3. Disease Control (DC): Phase II [From start of treatment until 134 weeks assessed every 8 weeks]

4. Duration of Response (DOR): Phase I [From start of treatment until 134 weeks assessed every 8 weeks]

5. Duration of Response: Phase II [From start of treatment until 134 weeks assessed every 8 weeks]

6. Time to Progression (TTP): Phase I [From start of treatment until 134 weeks assessed every 8 weeks]

7. Time to Progression (TTP): Phase II [From start of treatment until 134 weeks assessed every 8 weeks]

8. Progression-Free Survival (PFS): Phase I [From start of treatment until 134 weeks assessed every 8 weeks]

9. Progression-Free Survival (PFS): Phase II [From start of treatment until 134 weeks assessed every 8 weeks]

10. Overall Survival (OS): Phase I [From start of treatment until 134 weeks assessed every 8 weeks]

11. Overall Survival (OS): Phase II [From start of treatment until 134 weeks assessed every 8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female patients ≥18 years of age

• Histological or cytologically confirmed locally advanced, inoperable or metastatic pancreatic adenocarcinoma not amenable to curative radiotherapy or surgery

• Patients must have at least one uni-dimensional measurable lesion by CT or MRI according to RECIST, Version 1.1

• Resolution of all acute toxic effects of any prior local treatment to Common Terminology Criteria for Adverse Events (CTCAE) Grade </= 1

• Eastern Cooperative Oncology Group performance status (ECOG PS) </= 2

• Patient has cardiac function, within normal range, as measured by an echocardiogram

Exclusion Criteria:

• Known history of, or symptomatic metastatic brain or meningeal tumors

• History of cardiac disease

• Active clinically serious infections

• Clinically significant (ie. symptomatic) peripheral vascular disease

• Pregnant or lactating women; women of childbearing potential not employing adequate contraception

• Use of strong inhibitors or inducers of CYP3A4

• Prior systemic therapy for metastatic or locally advanced, unresectable pancreatic cancer, or other malignancy

• Previous gemcitabine or 5-fluorouracil (5-FU) given concurrently as radiosensitizers to radiation therapy in adjuvant intention if given within 6 months from start of study treatment

• Thrombotic or embolic events such within 6 months prior to start of study treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Aurora	Colorado	United States	80045
2		Pittsfield	Massachusetts	United States	01201
3		Bruxelles - Brussel		Belgium	1070
4		Bruxelles - Brussel		Belgium	1090
5		Edegem		Belgium	2650
6		Brno		Czechia	602 00
7		Olomouc		Czechia	775 20
8		CLERMONT-FERRAND Cedex 1		France	63003
9		Heilbronn	Baden-Württemberg	Germany	74078
10		München	Bayern	Germany	81377
11		Marburg	Hessen	Germany	35033
12		Bochum	Nordrhein-Westfalen	Germany	44892
13		Berlin		Germany	13353
14		Brescia	Lombardia	Italy	25124
15		Ancona	Marche	Italy	60126
16		Oslo		Norway	0310
17		Oslo		Norway
18		Bialystok		Poland	15-027
19		Gdansk		Poland	80-952
20		Warszawa		Poland	02-781
21		London		United Kingdom	SE1 9RT
22		London		United Kingdom	WC1E 6BT
23		London		United Kingdom

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe
• Click here to find results for studies related to Bayer Healthcare products.

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT01251640
• Other Study ID Numbers: 14905; 2010-019588-12
• First Posted: Dec 2, 2010
• Last Update Posted: Apr 8, 2021
• Last Verified: Apr 1, 2021

• Keywords provided by Bayer: pancreatic cancer,; MEK-inhibitor
• Additional relevant MeSH terms: Pancreatic Neoplasms; Gemcitabine

Study Results

No Results Posted as of Apr 8, 2021