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Brief Title: Safety, Tolerability and Pharmacokinetics of Oral CPL304110, in Adult Subjects With Advanced Solid Malignancies

A Phase I, Open-label, Multicentre, Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of Oral CPL304110, in Adult Subjects With Advanced Solid Malignancies

INTRODUCTION

  • Org Study ID: 01FGFR2018
  • Secondary ID: N/A
  • NTC ID: NCT04149691
  • Sponsor: Celon Pharma SA

BRIEF SUMMARY


The purpose of the study is to determine to evaluate safety and tolerability of CPL304110
when administered once daily to adults with advanced solid malignancies.

DETAILED DESCRIPTION


01FGFR2018 is an Open-label, Multicentre, Dose Escalation Study to Assess Safety,
Tolerability and Pharmacokinetics of Oral CPL304110, in Adult Subjects with Advanced Solid
Malignancies. The study consists of 3 parts: initial dose escalation (Part 1 - without FGFR,
fibroblast growth factor receptor, molecular aberrations), dose escalation (Part 2 - with
FGFR molecular aberrations) and dose extension (Part 3 - with FGFR molecular aberrations).


  • Overall Status
    Recruiting
  • Start Date
    July 19, 2019
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Maximum tolerated dose (MTD)

Primary Outcome 1 - Timeframe: First cycle of 28 days

Primary Outcome 2 - Measure: Safety profile

Primary Outcome 2 - Timeframe: First cycle of 28 days

CONDITION

  • Gastric Cancer
  • Bladder Cancer
  • Squamous Non-small Cell Lung Cancer
  • Cholangiocarcinoma
  • Sarcoma
  • Endometrial Cancer

ELIGIBILITY


Inclusion Criteria:

- Patient or legal guardian, if permitted by local regulatory authorities, provides
informed consent to participate in the study must be performed before any procedure's
protocol related

- age of ≥25 years old

- Performance Score ≥70 in accordance with the Karnofsky Performance Score (KPS),

- life expectancy period of at least 3 months on the screening day,

- Have measurable disease according to Response Evaluation Criteria in Solid Tumors
Version 1.1 (RECIST v1.1)

- subject (or his/her partner) of childbearing potential willingness to use acceptable
forms of contraception

- adequate blood, liver, renal and urine parameters

- phosphate levels within normal range

- HIV, HCV (hepatitis C virus) and HBV negative (hepatitis B virus),

- adequate cardiac function

Inclusion Criteria Specific for parts:

Part 1

- Patients with histologically confirmed advanced gastric cancer, bladder cancer,
squamous lung cancer or non-small cell lung cancer with squamous immunophenotype,
cholangiocarcinoma, sarcoma or endometrial cancer, be refractory to prior therapies
and without effective further treatment options.

Part 2 and 3

- Patients with histologically confirmed advanced gastric cancer, bladder cancer,
squamous lung cancer or non-small cell lung cancer with squamous immunophenotype, be
refractory to prior therapies and without effective further treatment options.

- Subject's archival formalin-fixed paraffin-embedded (FFPE) tumour sample available for
molecular alteration diagnostics, and/or a possibility to collect a new biopsy.

- Present molecular alteration within FGFR 1, 2 or 3

Exclusion Criteria:

- Any other current malignancy or malignancy diagnosed within the past five (5) years.

- Active brain metastases or leptomeningeal metastases.

- concurrent anticancer treatment within 28 days before the start of trial treatment;
major surgery within 28 days before the start of trial treatment); use of blood
transfusion within 7 days before the start of trial treatment,

- prior therapy with an agent directed to another FGFR inhibitor,

- pregnancy and/or breastfeeding,

- phosphate levels above the upper limit of normal,

- ectopic calcification/mineralization,

- endocrine alteration related to calcium/phosphate homeostasis e.g. parathyroid
disorders, history of parathyroidectomy,

- concomitant therapies increasing calcium/phosphate serum levels,

- inability to take oral medicines,

- corneal disorder and/or keratopathy,

- persisting toxicity related to prior therapy Grade > 1 CTCAE v5.0, except
polyneuropathy and alopecia,

- clinically significant (i.e., active) cardiovascular disease. History of abdominal
fistula, bowel obstruction (Grade IV), gastrointestinal perforation, intra-abdominal
abscess within 6 months of enrollment. Other significant diseases, which, in the
opinion of the investigator, might impair the subject's tolerance of trial treatment.

- Receipt of any organ transplantation including allogeneic stem-cell transplantation.

Exclusion Criteria Specific for parts:

Part 2 and 3

- No FFPE tumour sample available to conduct FGFR alteration eligibility tests and no
biopsy option.

Gender: All

Minimum Age: N/A

Maximum Age: 25 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: +48 791 690 990

Email: clinicaltrials@cros-cro.com

LOCATION

Facility Status Contact
Facility: Uniwersyteckie Centrum Kliniczne w Gdańsku
Gdańsk,
Poland
Status: Recruiting Contact: N/A
Facility: SP ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn,
Poland
Status: Recruiting Contact: N/A
Facility: Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie
Warsaw,
Poland
Status: Recruiting Contact: N/A
Facility: Instytut Gruźlicy i Chorób Płuc
Warsaw,
Poland
Status: Recruiting Contact: N/A