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Study to Evaluate the Safety of CB-280 in Patients With Cystic Fibrosis

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: NCT04279769
Recruitment Status : Recruiting
First Posted : February 21, 2020
Last Update Posted : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
Calithera Biosciences, Inc

Brief Summary:
This is a phase 1b multiple ascending dose escalation study to evaluate the safety and tolerability of arginase inhibitor CB-280 in subjects with cystic fibrosis.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: CB-280 Drug: Placebos Phase 1

Detailed Description:
Study CX-280-202 is a Phase 1b, randomized, double-blind, placebo-controlled, multiple ascending dose escalation study of CB-280 in adult subjects with cystic fibrosis and chronic infection with Pseudomonas aeruginosa. The study will evaluate the safety, pharmacokinetics, pharmacodynamics, and biological activity of CB-280 in approximately 32 adult patients with cystic fibrosis. There are four planned sequential dose escalation cohorts of 8 subjects each, randomized 6:2 to receive CB-280 or matched placebo at doses of 50 mg, 100 mg, 200 mg, or 400 mg administered twice daily for 14 days. Intermediate dose levels may be evaluated based on emerging safety data at the planned dose levels.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1b Randomized, Double-blind, Placebo-Controlled Trial to Evaluate the Safety of CB-280 in Patients With Cystic Fibrosis
Actual Study Start Date : July 3, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: Cohort 1
CB-280 twice daily at 50 mg for 14 days
Drug: CB-280
CB-280, oral capsule administered twice daily at the assigned dose level for 14 days

Experimental: Cohort 2
CB-280 twice daily at 100 mg for 14 days
Drug: CB-280
CB-280, oral capsule administered twice daily at the assigned dose level for 14 days

Experimental: Cohort 3
CB-280 twice daily at 200 mg for 14 days
Drug: CB-280
CB-280, oral capsule administered twice daily at the assigned dose level for 14 days

Experimental: Cohort 4
CB-280 twice daily at 400 mg for 14 days
Drug: CB-280
CB-280, oral capsule administered twice daily at the assigned dose level for 14 days

Placebo Comparator: Placebo
Placebo twice daily for 14 days
Drug: Placebos
Placebo oral capsule administrated twice daily at the assigned dose level for 14 days




Primary Outcome Measures :
  1. Determine the safety and tolerability of CB-280 in adult cystic fibrosis patients: incidence and severity of adverse event (AEs) assessed by Common Terminology Criteria for Adverse Events, version 5 (CTCAE v5.0) [ Time Frame: Start of treatment to Day 28 ]

Secondary Outcome Measures :
  1. Pharmacokinetics of plasma CB-280 measured by Peak Plasma Concentration (Cmax) [ Time Frame: Day 14 ]
  2. Pharmacokinetics of plasma CB-280 measured by area under the plasma concentration versus time curve, from time 0 to the last observed non-zero concentration (AUC 0-t) [ Time Frame: Day 14 ]


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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Criteria: Inclusion Criteria:

  1. Written Informed Consent in accordance with federal, local, and institutional guidelines
  2. Confirmed diagnosis of cystic fibrosis
  3. Male or female subjects ≥ 18 years on the date of informed consent
  4. Percent predicted FEV1 of 40-90% at screening per Global Lung Function Initiative (GLI) equation
  5. Clinically stable with no significant changes in health status within 28 days prior to Day 1
  6. Chronic lung infection with P. aeruginosa defined as at least two (2) positive sputum cultures in the past year, one of which was collected within the 6 months preceding Day 1
  7. Stable cystic fibrosis medication regimen for at least 28 days inclusive of CFTR modulators prior to Day 1
  8. Hemoglobin > 10 g/dL at screening
  9. Glomerular filtration rate > 50 mL/min/1.73 m2 at screening
  10. Normal liver function at screening

Exclusion Criteria:

  1. History of any comorbidity that, in the opinion of the Investigator, might pose an additional risk in administering study drug to the subject or confound the results of the study
  2. Colonization with Burkholderia species or non-tuberculous Mycobacterium species, defined as at least one positive sputum culture in the preceding 6 months
  3. Unable to receive study medication per os (PO)
  4. Females who are pregnant, have a positive pregnancy test at screening, or are nursing (lactating)

Other protocol defined Inclusion/Exclusion criteria may apply


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): NCT04279769


Contacts
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Contact: Clinical Administrator 650-870-1000 clinicaltrials@calithera.com

Locations
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United States, Illinois
Cystic Fibrosis Institute Recruiting
Glenview, Illinois, United States, 60025
Contact: Martha Cruz    847-998-3434      
Principal Investigator: Steven Boas, MD         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Megan White    913-917-8292      
Principal Investigator: Joel Mermis, MD         
United States, New York
New York Medical College at Westchester Medical Center Recruiting
Hawthorne, New York, United States, 10532
Contact: Armando Ramirez    914-593-8904      
Principal Investigator: Allen Dozor, MD         
United States, Pennsylvania
Hershey Medical Center Pennsylvania State University Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Diane Diane Kitch    717-531-5646      
Principal Investigator: Judie Howrylak, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Jessica Francis    801-587-8105      
Principal Investigator: Theodore G Liou, MD         
Sponsors and Collaborators
Calithera Biosciences, Inc
Investigators
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Study Director: Emil T Kuriakose, MD Calithera Bioscience
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Responsible Party: Calithera Biosciences, Inc
ClinicalTrials.gov Identifier: NCT04279769    
Other Study ID Numbers: CX-280-202
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Calithera Biosciences, Inc:
Arginase inhibitor
CB-280
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases