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Combination With Gemcitabine in Advanced Pancreatic Cancer (BAGPAC)

Primary Purpose

Pancreatic Neoplasms

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

BAY86-9766+Gemcitabine

About this trial

This is an interventional treatment trial for Pancreatic Neoplasms focused on measuring pancreatic cancer,, MEK-inhibitor

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Number of Subjects With Dose Limiting Toxicities (DLT): Phase I

Tumor Response (Adjudicated Blinded Read Assessment): Phase II

Secondary Outcome Measures

Tumor Response: Investigator Assessment: Phase I

Disease Control (DC): Phase I

Disease Control (DC): Phase II

Duration of Response (DOR): Phase I

Duration of Response: Phase II

Time to Progression (TTP): Phase I

Time to Progression (TTP): Phase II

Progression-Free Survival (PFS): Phase I

Progression-Free Survival (PFS): Phase II

Overall Survival (OS): Phase I

Overall Survival (OS): Phase II

Full Information

NCT ID

NCT01251640

First Posted

November 8, 2010

Last Updated

April 6, 2021

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01251640

Brief Title

Combination With Gemcitabine in Advanced Pancreatic Cancer

Acronym

BAGPAC

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

January 1, 2011 (Actual)

Primary Completion Date

February 11, 2013 (Actual)

Study Completion Date

August 1, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Neoplasms

Keywords

pancreatic cancer,, MEK-inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

BAY86-9766+Gemcitabine

Intervention Description

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)

Primary Outcome Measure Information:

Title

Number of Subjects With Dose Limiting Toxicities (DLT): Phase I

Time Frame

From randomization up to the first 8 weeks of therapy

Title

Tumor Response (Adjudicated Blinded Read Assessment): Phase II

Time Frame