Clinical trial NCT01251640: Combination With Gemcitabine in Advanced Pancreatic Cancer
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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pancreatic Neoplasms
Keywords: pancreatic cancer,
MEK-inhibitor
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-12-02
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects With Dose Limiting Toxicities (DLT): Phase I
timeFrame: From randomization up to the first 8 weeks of therapy
measure: Tumor Response (Adjudicated Blinded Read Assessment): Phase II
timeFrame: From start of treatment until 134 weeks assessed every 8 weeks
Secondary outcomes:
measure: Tumor Response: Investigator Assessment: Phase I
timeFrame: From start of treatment until 134 weeks assessed every 8 weeks
measure: Disease Control (DC): Phase I
timeFrame: From start of treatment until 134 weeks assessed every 8 weeks
measure: Disease Control (DC): Phase II
timeFrame: From start of treatment until 134 weeks assessed every 8 weeks
measure: Duration of Response (DOR): Phase I
timeFrame: From start of treatment until 134 weeks assessed every 8 weeks
measure: Duration of Response: Phase II
timeFrame: From start of treatment until 134 weeks assessed every 8 weeks
measure: Time to Progression (TTP): Phase I
timeFrame: From start of treatment until 134 weeks assessed every 8 weeks
measure: Time to Progression (TTP): Phase II
timeFrame: From start of treatment until 134 weeks assessed every 8 weeks
measure: Progression-Free Survival (PFS): Phase I
timeFrame: From start of treatment until 134 weeks assessed every 8 weeks
measure: Progression-Free Survival (PFS): Phase II
timeFrame: From start of treatment until 134 weeks assessed every 8 weeks
measure: Overall Survival (OS): Phase I
timeFrame: From start of treatment until 134 weeks assessed every 8 weeks
measure: Overall Survival (OS): Phase II
timeFrame: From start of treatment until 134 weeks assessed every 8 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
state: Colorado
city: Pittsfield
country: United States
state: Massachusetts
city: Bruxelles - Brussel
country: Belgium
city: Bruxelles - Brussel
country: Belgium
city: Edegem
country: Belgium
city: Brno
country: Czechia
city: Olomouc
country: Czechia
city: CLERMONT-FERRAND Cedex 1
country: France
city: Heilbronn
country: Germany
state: Baden-Württemberg
city: München
country: Germany
state: Bayern
city: Marburg
country: Germany
state: Hessen
city: Bochum
country: Germany
state: Nordrhein-Westfalen
city: Berlin
country: Germany
city: Brescia
country: Italy
state: Lombardia
city: Ancona
country: Italy
state: Marche
city: Oslo
country: Norway
city: Oslo
country: Norway
city: Bialystok
country: Poland
city: Gdansk
country: Poland
city: Warszawa
country: Poland
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: