Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04149691
Recruitment Status : Recruiting
First Posted : November 4, 2019
Last Update Posted : June 9, 2020
Sponsor:
Collaborator:
National Center for Research and Development, Poland
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Bladder Cancer Squamous Non-small Cell Lung Cancer Cholangiocarcinoma Sarcoma Endometrial Cancer Drug: CPL304110 Phase 1

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 19, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020


Arm Intervention/treatment
Experimental: CPL304110
CPL304110 will be administered once daily to adults with advanced solid malignancies in 28-day cycles.
Drug: CPL304110
CPL304110 is to be administered orally as hard gelatine capsules once daily in 28-day cycles.
Other Name: PG19




Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) [ Time Frame: First cycle of 28 days ]
    Maximum tolerated dose (MTD) of CPL304110 when administered orally once daily to adults with advanced solid malignancies. The MTD is the highest dose associated with the occurrence of dose-limiting toxicities (DLTs) in <33% of patients.

  2. Safety profile [ Time Frame: First cycle of 28 days ]
    Overall safety profile of CPL304110, as assessed by the type, frequency, severity, timing, and relationship to study drug of any adverse events (AEs), serious adverse events (SAEs), and changes in vital signs, ECGs, and safety laboratory test.


Secondary Outcome Measures :
  1. Recommended Phase 2 Dose (RP2D) determined on the base of the MTD. [ Time Frame: Approximately up to 12 months ]
    The RP2D will be determined after review and discussion of the pharmacokinetics (PK) profile, type and severity of drug related toxicity and clinical suitability for long-term administration.

  2. ORR, objective rate response [ Time Frame: Approximately up to 12 months ]
    ORR, objective rate response defined as the rate of confirmed complete response (CR) or partial response (PR) by RECIST 1.1.

  3. Maximum plasma concentration (Cmax) [ Time Frame: up to 24 hours after CPL304110 administration ]
    Cmax defines the maximum concentration of the product in plasma during observation period.

  4. Time to maximum plasma concentration (tmax) [ Time Frame: up to 24 hours after CPL304110 administration ]
    tmax defines Time to reach maximum plasma concentration

  5. Area under the plasma concentration versus time curve (AUC) from 0 up to the time of last quantifiable concentration (AUC0-t) [ Time Frame: up to the time of last quantifiable concentration after CPL304110 administration ]
    AUC(0-t) defines the area under the curve of plasma concentration vs time, from time point zero up to the time of last quantifiable concentration

  6. Area under the plasma concentration versus time curve AUC from 0 to infinity (AUC0-inf) [ Time Frame: up to 24 hours after CPL304110 administration ]
    AUC0-inf defines the area under the curve of plasma concentration vs time, from time point zero extrapolated to infinity

  7. Terminal half-life (t½) [ Time Frame: up to 24 hours after CPL304110 administration ]
    Plasma elimination half-life

  8. Kel: Terminal elimination rate constant [ Time Frame: up to 24 hours after CPL304110 administration ]
    Terminal elimination rate constant



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04149691


Contacts
Layout table for location contacts
Contact: CROS CRO +48 791 690 990 clinicaltrials@cros-cro.com

Locations
Layout table for location information
Poland
Uniwersyteckie Centrum Kliniczne w Gdańsku Recruiting
Gdańsk, Poland
BioResearch Group sp. z o.o. Recruiting
Nadarzyn, Poland
SP ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie Recruiting
Olsztyn, Poland
Klinika Onkologii, Europejskie Centrum Zdrowia Not yet recruiting
Otwock, Poland
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Recruiting
Warsaw, Poland
Instytut Gruźlicy i Chorób Płuc Recruiting
Warsaw, Poland
Wojskowy Instytut Medyczny Not yet recruiting
Warsaw, Poland
Sponsors and Collaborators
Celon Pharma SA
National Center for Research and Development, Poland
Layout table for additonal information
Responsible Party: Celon Pharma SA
ClinicalTrials.gov Identifier: NCT04149691    
Other Study ID Numbers: 01FGFR2018
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celon Pharma SA:
FGFR
kinase inhibitor
advanced solid tumors
carcinoma
neoplasms
gastric cancer
bladder cancer
squamous non-small cell lung cancer
squamous immunophenotype
Additional relevant MeSH terms:
Layout table for MeSH terms
Stomach Neoplasms
Urinary Bladder Neoplasms
Endometrial Neoplasms
Cholangiocarcinoma
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Bronchial Neoplasms
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Neoplasms, Glandular and Epithelial
Carcinoma, Non-Small-Cell Lung
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Urinary Bladder Diseases
Urologic Diseases
Uterine Diseases
Genital Diseases, Female
Adenocarcinoma