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BRIEF TITLE: Phase I Dose Escalation Study to Characterize Safety, Tolerability, Pharmacokinetics and Maximum Tolerated Dose of BAY1163877 in Subjects With Refractory, Locally Advanced or Metastatic Solid Tumors

An Open Label, Non-randomized, Phase I Dose Escalation Study to Characterize Safety, Tolerability, Pharmacokinetics and Maximum Tolerated Dose of BAY1163877 in Subjects With Refractory, Locally Advanced or Metastatic Solid Tumors


  • Org Study ID: 16443
  • Secondary ID: 2013-002155-15
  • NCT ID: NCT01976741
  • NCT Alias:
  • Sponsor: Bayer - Industry
  • Source: Bayer

Brief Summary

- This is the first study where BAY1163877 is given to humans. Impact of the study is to evaluate if patients with advanced solid cancers show advanced clinical benefit under the treatment with the pan FGFR inhibitor. Patients (all comers) will receive the study drug treatment in a dose-escalation scheme (no placebo group) to determine the safety, tolerability and maximum tolerated dose (MTD) of BAY1163877. The relative bioavailability of liquid service formulation and tablets will be determined. - After the MTD is defined patients with solid tumors (all comers), lung cancer (lung adenocarcinoma & squamous non-small cell lung cancer), head and neck cancer or bladder cancer will be enrolled according to their FGFR expression profile (biomarker stratification). - The study will also assess the pharmacokinetics, biomarker status, pharmacodynamic parameters and tumor response of BAY1163877. - BAY1163877 will be given twice daily as oral application. Treatment will be stopped if the tumor continues to grow, if side effects, which the patient cannot tolerate, occur or if the patient decides to exit treatment.

Overal Status Start Date Phase Study Type
Recruiting December 30, 2013 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Maximum tolerated dose (MTD), defined as maximum dose at which the incidence of Drug Limiting Toxicities (DLTs) during cycle 1 is below 20%

Primary Outcome 1 - Time Frame: up to 21 days

Primary Outcome 2 - Measure: Cmax(maximum drug concentration in plasma after first dose administration)

Primary Outcome 2 - Time Frame: Cycle 1 day -3 and cycle 1,day 1

Primary Outcome 3 - Measure: AUC(0-12) (AUC from time zero to 12 hours p.a. after first-dose administration

Primary Outcome 3 - Time Frame: Cycle 1 day -3 and cycle 1,day 1

Primary Outcome 4 - Measure: AUC(0-tlast) (AUC from time zero to the last data point > LLOQ)

Primary Outcome 4 - Time Frame: Cycle 1 day -3 and cycle 1,day 1

Primary Outcome 5 - Measure: AUC (area under the plasma concentration vs time curve from zero to infinity after single (first) dose)

Primary Outcome 5 - Time Frame: Cycle 1 day -3 and cycle 1,day 1

Primary Outcome 6 - Measure: Cmax/D (maximum drug concentration in plasma after single dose administration divided by dose)

Primary Outcome 6 - Time Frame: Cycle 1 day -3 and cycle 1,day 1

Primary Outcome 7 - Measure: AUC(0-12)/D(AUC from time zero to 12 hours after single dose administration divided by dose)

Primary Outcome 7 - Time Frame: Cycle 1 day -3 and cycle 1,day 1

Primary Outcome 8 - Measure: AUC(0-tlast)/D (AUC from time zero to the last data point >>LLOQ(lower limit of quantification) after single dose administration divided by dose

Primary Outcome 8 - Time Frame: Cycle 1 day -3 and cycle 1,day 1

Primary Outcome 9 - Measure: AUC/D (AUC divided by dose)

Primary Outcome 9 - Time Frame: Cycle 1 day -3 and cycle 1,day 1

Primary Outcome 10 - Measure: Cmax,md (Cmax after multiple-dose administration)

Primary Outcome 10 - Time Frame: Cycle1, day 15

Primary Outcome 11 - Measure: Cmax/Dmd (Maximum drug concentration in plasma after multiple dose administration divided by dose)

Primary Outcome 11 - Time Frame: Cycle1, day 15

Primary Outcome 12 - Measure: AUC(0-12)md (AUC(0-12) after multiple-dose administration)

Primary Outcome 12 - Time Frame: Cycle1, day 15

Primary Outcome 13 - Measure: AUC(0-12)/Dmd (AUC from time zero to 12 hours after multiple dose administration divided by dose

Primary Outcome 13 - Time Frame: Cycle1, day 15

Primary Outcome 14 - Measure: AUC(0-tlast)md (AUC from time zero to the last data point>LLOQ after multiple dose administration)

Primary Outcome 14 - Time Frame: Cycle1, day 15

Primary Outcome 15 - Measure: AUC(0-tlast)/Dmd (AUC from time zero to the last data point>LLOQ after multiple dose administration divided by dose)

Primary Outcome 15 - Time Frame: Cycle1, day 15

Primary Outcome 16 - Measure: AE,ur(0-12) amount of drug excreted via urine during the collection interval 0 - 12 hours post administration

Primary Outcome 16 - Time Frame: Cycle1, day 1

Primary Outcome 17 - Measure: AE,ur(0-24) amount of drug excreted via urine during the collection interval 0 - 24 hours post administration

Primary Outcome 17 - Time Frame: Cycle1, day 1

Primary Outcome 18 - Measure: AE,ur(12-24) amount of drug excreted via urine during the collection interval 12 - 24 hours post administration

Primary Outcome 18 - Time Frame: Cycle1, day 1

Condition:

  • Neoplasms

Eligibility

Criteria:
Inclusion Criteria:

- For dose escalation: Subjects with any type of solid tumor (all comer) will be
eligible for dose escalation and dose expansion at MTD in Part 1; Subjects enrolled
for dose expansion (MTD expansion cohort all comer") will be stratified according to
high fibroblast growth factor receptor (FGFR) expression levels / FGFR mutation using
archival or fresh tumor biopsy material

- For expansion cohorts: Subjects will be eligible for Part 2 only if they have
histological or cytological confirmed squamous non-small cell lung cancer (sqNSCLC),
lung adenocarcinoma, head and neck cancer or bladder cancer (BC). All subjects in Part
2 will be stratified according to high FGFR expression levels FGFR mutation using
archival or fresh tumor biopsy specimen. BC subjects with low overall FGFR expression
levels can be included if activating FGFR3(FGFR tyrosine kinases3) mutations are
confirmed

- Subjects must have measurable disease (Response evaluation criteria in solid tumors
(RECIST 1.1))

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2

- Bone marrow, liver and renal functions as assessed by adequate laboratory methods to
be conducted within 7 days prior to starting study Treatment

- Glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m2 according to the modified diet in
renal disease (MDRD) abbreviated formula

Exclusion Criteria:

- Previous treatment with anti-FGFR directed therapies (e.g. receptor tyrosine kinase
inhibitors or FGFR-specific antibodies)

- Concomitant therapies that cannot be discontinued or switched to a different
medication prior to study entry that are known to increase serum phosphate levels are
not permitted within 4 weeks prior to start of study treatment)

- Anticancer chemotherapy or immunotherapy during the study or within 5-halflives prior
to start of study treatment. Mitomycin C, nitrosoureas or monoclonal antibodies with
anticancer activity (e.g. bevacizumab or cetuximab etc.) should not be given within 6
weeks before starting to receive study treatment or within 6 weeks of pre-treatment
biopsy for biomarker (p-ERK1/2) studies
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Bayer Study Director

Role: Study Director

Affiliation: Bayer

Overall Contact

Name: Bayer Clinical Trials Contact

Phone: (+) 1-888-8422937

Email: clinical-trials-contact@bayer.com

Link: Click here and search for drug information provided by the FDA.

Locations

Facility Status Contact

New Haven, Connecticut 06510
United States
Terminated

Chicago, Illinois 60611-2908
United States
Recruiting

Chicago, Illinois
United States
Recruiting

Pittsburgh, Pennsylvania 15232
United States
Not yet recruiting

Besancon, 25030
France
Recruiting

Creteil, 94010
France
Recruiting

Dijon, 21000
France
Recruiting

Lille Cedex, 59020
France
Recruiting

Lyon Cedex, 69008
France
Recruiting

Heidelberg, Baden-Württemberg 69120
Germany
Recruiting

Tübingen, Baden-Württemberg 72076
Germany
Recruiting

Weiden, Bayern 92637
Germany
Recruiting

Würzburg, Bayern 97080
Germany
Recruiting

Bochum, Nordrhein-Westfalen 44791
Germany
Terminated

Essen, Nordrhein-Westfalen 45147
Germany
Recruiting

Köln, Nordrhein-Westfalen 50937
Germany
Recruiting

Dresden, Sachsen 01307
Germany
Recruiting

Lübeck, Schleswig-Holstein 23538
Germany
Not yet recruiting

Jena, Thüringen 07740
Germany
Not yet recruiting

Hamburg, 20246
Germany
Recruiting

Magdeburg, 39120
Germany
Recruiting

Seoul, 03080
Korea, Republic of
Recruiting

Seoul, 120-752
Korea, Republic of
Recruiting

Seoul, 135-710
Korea, Republic of
Recruiting

Singapore, 119228
Singapore
Recruiting

Singapore, 169610
Singapore
Recruiting

Barcelona, 08035
Spain
Recruiting

Madrid, 28034
Spain
Recruiting

Madrid, 28041
Spain
Recruiting

Valencia, 46014
Spain
Recruiting

Chur, Graubünden 7000
Switzerland
Recruiting

St. Gallen, Sankt Gallen 9007
Switzerland
Recruiting

Lausanne, Vaud 1011
Switzerland
Terminated

Genève, 1205
Switzerland
Recruiting