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Brief Title: Rogaratinib With Copanlisib in Patients With Fibroblast Growth Factor Receptor (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

INTRODUCTION

  • Org Study ID: 19774
  • Secondary ID: 2018-000419-26
  • NTC ID: NCT03517956
  • Sponsor: 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.


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

PRIMARY OUTCOMES

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

Primary Outcome 1 - Timeframe: Up to 32 months

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

Primary Outcome 2 - Timeframe: Up to 32 months

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

Primary Outcome 3 - Timeframe: Up to 32 months

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

Primary Outcome 4 - Timeframe: Approximately 10 months

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

Primary Outcome 5 - Timeframe: Up to 22 months

CONDITION

  • Advanced or Metastatic Solid Tumor

ELIGIBILITY


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).

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: (+)1-888-84 22937

Email: clinical-trials-contact@bayer.com

LOCATION

Facility Status Contact
Facility: USC Norris Hospital and Clinics
Los Angeles, California 90033
United States 		Status: Recruiting Contact: N/A
Facility: Northwestern University
Chicago, Illinois 60611
United States 		Status: Recruiting Contact: N/A
Facility: University of Maryland
Baltimore, Maryland 12101
United States 		Status: Recruiting Contact: N/A
Facility: Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States 		Status: Recruiting Contact: N/A
Facility: Barbara Ann Karmanos Cancer Institute
Detroit, Michigan 48201
United States 		Status: Recruiting Contact: N/A
Facility: Memorial Sloan-Kettering Cancer Center
New York, New York 10065
United States 		Status: Recruiting Contact: N/A
Facility: Tyler Cancer Center
Tyler, Texas 75702
United States 		Status: Recruiting Contact: N/A
Facility: CU Saint-Luc/UZ St-Luc
Bruxelles - Brussel, 1200
Belgium 		Status: Recruiting Contact: N/A
Facility: UZ Antwerpen
Edegem, 2650
Belgium 		Status: Recruiting Contact: N/A
Facility: CHU de Liège
Liege, 4000
Belgium 		Status: Recruiting Contact: N/A
Facility: Krankenhaus Nordwest
Frankfurt, Hessen 60488
Germany 		Status: Recruiting Contact: N/A
Facility: Universitätsklinikum Köln
Köln, Nordrhein-Westfalen 50937
Germany 		Status: Recruiting Contact: N/A
Facility: Klinikum der Universität Würzburg
Würzburg, 97080
Germany 		Status: Recruiting Contact: N/A
Facility: Asan Medical Center
Seoul, 05505
Korea, Republic of 		Status: Recruiting Contact: N/A
Facility: Samsung Medical Center
Seoul, 06351
Korea, Republic of 		Status: Recruiting Contact: N/A
Facility: Yonsei University College of Medicine
Seoul, 120-752
Korea, Republic of 		Status: Recruiting Contact: N/A
Facility: National University Hospital
Singapore, 119074
Singapore 		Status: Recruiting Contact: N/A
Facility: National Cancer Center
Singapore, 169610
Singapore 		Status: Recruiting Contact: N/A
Facility: Ciutat Sanitària i Universitaria de la Vall d'Hebron
Barcelona, 08035
Spain 		Status: Recruiting Contact: N/A
Facility: Hospital Clínico Universitario de Valencia
Valencia, 46010
Spain 		Status: Recruiting Contact: N/A

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