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BRIEF TITLE: Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of the Combination of Rogaratinib and Copanlisib in Patients With FGFR-positive, Locally Advanced or Metastatic Solid Tumors

A Multicenter Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of the Combination of Rogaratinib and Copanlisib in Patients With FGFR-positive, Locally Advanced or Metastatic Solid Tumors


  • Org Study ID: 19774
  • Secondary ID: 2018-000419-26
  • NCT ID: NCT03517956
  • NCT Alias:
  • Sponsor: Bayer - Industry
  • Source: Bayer

Brief Summary

The primary objective of this study is to determine the safety, tolerability, maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) and efficacy of rogaratinib in combination with copanlisib in patients with locally advanced or metastatic solid tumors that are mRNA-positive for at least one FGFR1-4 subtype. The secondary objectives of this study are to characterize the pharmacokinetics (PK) of rogaratinib and copanlisib alone and in combination, and to assess the anti-tumor efficacy of rogaratinib in combination with copanlisib for locally advanced or metastatic solid tumors that are mRNA-positive for at least one FGFR1-4 subtype.

Overal Status Start Date Phase Study Type
Recruiting July 25, 2018 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Incidence of treatment-emergent adverse events (TEAEs)

Primary Outcome 1 - Time Frame: Up to 32 months

Primary Outcome 2 - Measure: Incidence of drug-related TEAEs

Primary Outcome 2 - Time Frame: Up to 32 months

Primary Outcome 3 - Measure: Incidence of treatment-emergent serious adverse events (TESAEs)

Primary Outcome 3 - Time Frame: Up to 32 months

Primary Outcome 4 - Measure: Incidence of Dose-limiting toxicities (DLTs)

Primary Outcome 4 - Time Frame: Approximately 10 months

Primary Outcome 5 - Measure: Objective response rate (ORR) at recommended dose

Primary Outcome 5 - Time Frame: Up to 22 months

Condition:

  • Advanced or Metastatic Solid Tumor

Eligibility

Criteria:
Inclusion Criteria:

- High FGFR mRNA expression levels (RNAscope score of ≥3; measurement is part of this
protocol) in archival or fresh tumor biopsy specimen.

- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.

- At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors
(RECIST 1.1) in contrast enhanced (unless contraindicated) CT or MRI.

- Adequate bone marrow, liver and renal function.

- Glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m2 according to the Modification of
Diet in Renal Disease (MDRD) formula.

- Left ventricular ejection fraction (LVEF) equal to or above the lower limit of normal
(LLN) at the institution.

- Life expectancy of at least 3 months.

- For the dose escalation part: Patients with histologically confirmed, locally advanced
or metastatic solid tumors who are not candidates for or refuse standard therapy or
whose disease progressed and for which standard anti-cancer treatment is no longer
effective, excluding primary brain or spinal tumors. Patients who have been advised
with all standard treatment options and still refuse them must be documented and can
be allowed to enter the trial.

- For the dose expansion part: Patients with histologically confirmed, locally advanced
or metastatic urothelial carcinoma (transitional cell carcinoma) including urinary
bladder, renal pelvis, ureters, urethra who are not candidates for or refuse standard
therapy or whose disease progressed and for which standard anticancer treatment is no
longer effective. Patients who have been advised with all standard treatment options
and still refuse them must be documented and can be allowed to enter the trial.

Exclusion Criteria:

- Previous or concurrent cancer that is distinct from tumor for which the patient is
enrolled in study, with exceptions

- Ongoing or previous anti-cancer treatment within 4 weeks of study treatment start (or
6 weeks for mitomycin C, nitrosoureas and monoclonal antibodies); with exceptions.

- Prior toxicity to anti-FGFR-directed or anti-PI3K-directed therapies leading to
treatment discontinuation (previous exposure is allowed in other circumstances). If
prior toxicity to anti-FGFR-directed or anti-PI3K-directed therapies leading to
treatment discontinuation is different from the known safety profile of rogaratinib or
copanlisib, enrollment is allowed.

- Symptomatic brain or meningeal metastatic tumors unless the patient is >6 months from
definitive therapy, has no evidence of tumor growth on an imaging study and is
clinically stable with respect to the tumor at the start of study treatment. Also the
patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy
is acceptable provided that the dose is stable for one month prior to and following
screening radiographic studies).

- History or current condition of an uncontrolled cardiovascular disease including
congestive heart failure NYHA > Class 2, unstable angina (symptoms of angina at rest)
or new-onset angina (within last 3 months) or myocardial infarction within past 6
months and cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or
digoxin are permitted).

- Active hepatitis B (HBV) or C (HCV) infection.

- Active clinically serious infections (≥ CTCAE v4.03 Grade 2).
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Bayer Clinical Trials Contact

Phone: (+)1-888-84 22937

Email: clinical-trials-contact@bayer.com

Locations

Facility Status Contact
USC Norris Hospital and Clinics
Los Angeles, California 90033
United States
Recruiting
Northwestern University
Chicago, Illinois 60611
United States
Recruiting
University of Maryland
Baltimore, Maryland 12101
United States
Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Recruiting
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89169
United States
Not yet recruiting
Memorial Sloan-Kettering Cancer Center
New York, New York 10065
United States
Recruiting
Prisma Health
Greenville, South Carolina 29605
United States
Not yet recruiting
Texas Oncology- Austin Midtown
Austin, Texas 78705
United States
Not yet recruiting
Tyler Cancer Center
Tyler, Texas 75702
United States
Recruiting
CU Saint-Luc/UZ St-Luc
Bruxelles - Brussel, 1200
Belgium
Recruiting
UZ Antwerpen
Edegem, 2650
Belgium
Recruiting
CHU de Liège
Liege, 4000
Belgium
Recruiting
Centre Oscar Lambret - Lille
LILLE cedex, 59020
France
Withdrawn
Centre Léon Bérard
Lyon Cedex, 69008
France
Withdrawn
Krankenhaus Nordwest
Frankfurt, Hessen 60488
Germany
Recruiting
Universitätsklinikum Köln
Köln, Nordrhein-Westfalen 50937
Germany
Recruiting
Universitätsklinikum Hamburg Eppendorf (UKE)
Hamburg, 20246
Germany
Withdrawn
Klinikum der Universität Würzburg
Würzburg, 97080
Germany
Recruiting
Asan Medical Center
Seoul, 05505
Korea, Republic of
Recruiting
Samsung Medical Center
Seoul, 06351
Korea, Republic of
Recruiting
Yonsei University College of Medicine
Seoul, 120-752
Korea, Republic of
Recruiting
National University Hospital
Singapore, 119074
Singapore
Recruiting
National Cancer Center
Singapore, 169610
Singapore
Recruiting
Ciutat Sanitària i Universitaria de la Vall d'Hebron
Barcelona, 08035
Spain
Recruiting
Hospital Clínic i Provincial de Barcelona
Barcelona, 08036
Spain
Withdrawn
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Spain
Withdrawn
MD Anderson International Espanya, S.A.
Madrid, 28033
Spain
Withdrawn
Hospital Clínico Universitario de Valencia
Valencia, 46010
Spain
Recruiting