RECRUITING

Phase 1 Study of Oral RH324 in Advanced Non-Small Cell Lung Cancer

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Phase 1 open label dose ranging study of RH324 in advanced non-small cell lung cancer

Official Title

A Phase 1 Open Label Dose Ranging Study of Oral RH324 in Advanced Non-Small Cell Lung Cancer

Quick Facts

Study Start:2022-06-01

Study Completion:2025-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05580172

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Advanced Non-Small Cell Lung Cancer * Measurable Target Lesion by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * Failed all standard of care including chemotherapy, targeted therapy, and immunotherapy * Adults over 18 years * Performance status (Eastern Cooperative Oncology Group) less than or equal to 2 * Life expectancy greater than 2 months * Laboratory Values: * No history of hyperthyroidism * Abstinence from alcohol and supplements * Not pregnant, lactating and willing to use birth control throughout study * Able to provide consent * Positive Emission Tomography/Computer Tomography part of subjects care plan at baseline	* Prior use of Withania somnifera * Phenylketonuria * Inability to swallow capsules * Hypersensitivity to study drug ingredients * Unstable medical or surgical condition * History of additional cardiac risk factors * Requiring drugs that are "strong" inhibitors of cytochrome P450 * Requiring irradiation * Requiring intravenous fluids or hyperalimentation * Requiring transfusions, dialysis, or other procedures * Active infection * Human Immunodeficiency Virus * Must exceed washout period of prior treatments * Psychiatric, neurological or other reason that precludes subjects ability to participate

Inclusion Criteria

Exclusion Criteria

* Advanced Non-Small Cell Lung Cancer
* Measurable Target Lesion by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Failed all standard of care including chemotherapy, targeted therapy, and immunotherapy
* Adults over 18 years
* Performance status (Eastern Cooperative Oncology Group) less than or equal to 2
* Life expectancy greater than 2 months
* Laboratory Values:
* No history of hyperthyroidism
* Abstinence from alcohol and supplements
* Not pregnant, lactating and willing to use birth control throughout study
* Able to provide consent
* Positive Emission Tomography/Computer Tomography part of subjects care plan at baseline

* Prior use of Withania somnifera
* Phenylketonuria
* Inability to swallow capsules
* Hypersensitivity to study drug ingredients
* Unstable medical or surgical condition
* History of additional cardiac risk factors
* Requiring drugs that are "strong" inhibitors of cytochrome P450
* Requiring irradiation
* Requiring intravenous fluids or hyperalimentation
* Requiring transfusions, dialysis, or other procedures
* Active infection
* Human Immunodeficiency Virus
* Must exceed washout period of prior treatments
* Psychiatric, neurological or other reason that precludes subjects ability to participate

Contacts and Locations

Study Contact

Charles Packard

CONTACT

517-518-8194

Charles.packard@parexel.com

Study Locations (Sites)

Case Comprehensive Cancer Center University Hospitals

Cleveland, Ohio, 44106

United States

Collaborators and Investigators

Sponsor: ReHeva Biosciences,Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-01

Study Completion Date2025-01-01

Study Record Updates

Study Start Date2022-06-01

Study Completion Date2025-01-01

Terms related to this study

Additional Relevant MeSH Terms

Safety Issues