Trial record 1 of 1 for:
cb-280 | Cystic Fibrosis
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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04279769 |
|
Recruitment Status :
Completed
First Posted : February 21, 2020
Last Update Posted : April 13, 2022
|
Sponsor:
Calithera Biosciences, Inc
Information provided by (Responsible Party):
Calithera Biosciences, Inc
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual 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 |
| Actual Primary Completion Date : | November 23, 2021 |
| Actual Study Completion Date : | November 23, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Cystic fibrosis
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 :
- 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 :
- Pharmacokinetics of plasma CB-280 measured by Peak Plasma Concentration (Cmax) [ Time Frame: Day 14 ]
- 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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Written Informed Consent in accordance with federal, local, and institutional guidelines
- Confirmed diagnosis of cystic fibrosis
- Male or female subjects ≥ 18 years on the date of informed consent
- Percent predicted FEV1 of 40-90% at screening per Global Lung Function Initiative (GLI) equation
- Clinically stable with no significant changes in health status within 28 days prior to Day 1
- Chronic lung infection with P. aeruginosa defined as at least one positive culture in the last two years and more than 50% of cultures positive since then
- Stable cystic fibrosis medication regimen for at least 28 days inclusive of CFTR modulators prior to Day 1
- Hemoglobin > 10 g/dL at screening
- Glomerular filtration rate > 50 mL/min/1.73 m2 at screening
- Normal liver function at screening
Exclusion Criteria:
- 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
- Lung infection with organisms associated with a more rapid decline in pulmonary status (including, but not limited to, Burkholderia cenocepacia, Burkholderia dolosa, and Mycobacterium abscessus)
- Unable to receive study medication per os (PO)
- 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
Locations
Show 20 study locations
Sponsors and Collaborators
Calithera Biosciences, Inc
Investigators
| Study Director: | Emil T Kuriakose, MD | Calithera Bioscience |
| 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: | April 13, 2022 |
| Last Verified: | April 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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:
|
Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases |
Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |