RECRUITING

Study of ON 123300 in Patients With Advanced Cancer

Conditions

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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

This study will investigate the safety of the drug ON 123300 at increasing doses to determine the best dose to use in future clinical trials.

Official Title

Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of ON 123300 Capsules Administered Orally as Escalating Daily Doses in Patients With Advanced Cancer Relapsed or Refractory to at Least One (1) Prior Line of Therapy

Quick Facts

Study Start:2021-05-13

Study Completion:2024-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04739293

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
1. ≥ 18 years of age the time of signing the informed consent form (ICF); 2. Histological or cytological evidence of advanced and/or metastatic cancer, 1. For Dose Escalation Cohorts, patients with measurable or non-measurable disease; 2. For RP2D Expansion Cohort, patients with measurable disease; 3. Patients must have received and failed at least one prior approved treatment, or have no therapeutic options available as deemed appropriate by their treating physician; 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of \< 2; 5. Life expectancy of \> 3 months; 6. Patients must be able to swallow oral capsules; 7. Women of child-bearing potential must have a negative serum screening for pregnancy within 14 days prior to screening. Women and men of child-bearing potential must agree to use highly effective methods of birth control before entry and throughout the study, for up to 12 weeks following the last dose of ON 123300. 8. Patients must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted; 9. Patients must have the ability to understand the nature of the study and any hazards of participating in the study and communicate satisfactorily with the investigator to participate in the study. 10. Patients must be willing and able to adhere and comply to the requirements of the entire study including study visit schedule and other protocol requirements; 11. Have adequate organ function, including:	1. Patients that have any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating in the study or present an unacceptable risk to the patient; 2. Patients at risk for Torsades de pointes (TdP): 1. Who have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>480 milliseconds (ms) (CTCAE grade 1) using Fredericia's QT correction formula, or 2. who have a history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome), or 3. who are currently taking medications that prolong the QT/QTc interval; 3. Patients with a diagnosis of hematological malignancies except for non-Hodgkin's lymphoma; 4. Have received recent chemotherapy, hormonal therapy, other targeted cancer treatment, or investigational therapy within 14 days of planned first dose; 5. Patients currently taking or within 5 half-lives of taking strong inducers and inhibitors of CYP2C8 and CYP3A4; 6. History of allergic reaction attributed to compounds of similar chemical or biologic composition/structure to ON 123300 (e.g. prior CDK4/6 inhibitors); 7. Uncontrolled intercurrent illness including but not limited to ongoing or active infection, bleeding, congestive heart failure, unstable angina, cardiac arrhythmia, oxygen-dependent lung disease, psychiatric illness/social situations that limit participation compliance with study procedures and requirements; 8. Patients with a recent history of venous thromboembolic events, defined as event occurring ≤ 6 months prior to screening and also currently on therapy; 9. Patients with baseline Grade ≥ 2 diarrhea; 10. Patients with Grade ≥ 3 hypercalcemia (Corrected serum calcium \> 12.5 mg/dL); 11. Pregnant or nursing mothers; 12. Have had major surgery within 14 days prior to screening to allow for post-operative healing of the surgical wound and site(s). 13. Have received recent (within 28 days prior to screening) live attenuated vaccines. 14. Have active bacterial, fungal or detectable viral infection (e.g. Human Immunodeficiency Virus or Hepatitis B or Hepatitis C).

Inclusion Criteria

Exclusion Criteria

1. ≥ 18 years of age the time of signing the informed consent form (ICF);
2. Histological or cytological evidence of advanced and/or metastatic cancer,
1. For Dose Escalation Cohorts, patients with measurable or non-measurable disease;
2. For RP2D Expansion Cohort, patients with measurable disease;
3. Patients must have received and failed at least one prior approved treatment, or have no therapeutic options available as deemed appropriate by their treating physician;
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of \< 2;
5. Life expectancy of \> 3 months;
6. Patients must be able to swallow oral capsules;
7. Women of child-bearing potential must have a negative serum screening for pregnancy within 14 days prior to screening. Women and men of child-bearing potential must agree to use highly effective methods of birth control before entry and throughout the study, for up to 12 weeks following the last dose of ON 123300.
8. Patients must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted;
9. Patients must have the ability to understand the nature of the study and any hazards of participating in the study and communicate satisfactorily with the investigator to participate in the study.
10. Patients must be willing and able to adhere and comply to the requirements of the entire study including study visit schedule and other protocol requirements;
11. Have adequate organ function, including:

1. Patients that have any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating in the study or present an unacceptable risk to the patient;
2. Patients at risk for Torsades de pointes (TdP):
1. Who have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>480 milliseconds (ms) (CTCAE grade 1) using Fredericia's QT correction formula, or
2. who have a history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome), or
3. who are currently taking medications that prolong the QT/QTc interval;
3. Patients with a diagnosis of hematological malignancies except for non-Hodgkin's lymphoma;
4. Have received recent chemotherapy, hormonal therapy, other targeted cancer treatment, or investigational therapy within 14 days of planned first dose;
5. Patients currently taking or within 5 half-lives of taking strong inducers and inhibitors of CYP2C8 and CYP3A4;
6. History of allergic reaction attributed to compounds of similar chemical or biologic composition/structure to ON 123300 (e.g. prior CDK4/6 inhibitors);
7. Uncontrolled intercurrent illness including but not limited to ongoing or active infection, bleeding, congestive heart failure, unstable angina, cardiac arrhythmia, oxygen-dependent lung disease, psychiatric illness/social situations that limit participation compliance with study procedures and requirements;
8. Patients with a recent history of venous thromboembolic events, defined as event occurring ≤ 6 months prior to screening and also currently on therapy;
9. Patients with baseline Grade ≥ 2 diarrhea;
10. Patients with Grade ≥ 3 hypercalcemia (Corrected serum calcium \> 12.5 mg/dL);
11. Pregnant or nursing mothers;
12. Have had major surgery within 14 days prior to screening to allow for post-operative healing of the surgical wound and site(s).
13. Have received recent (within 28 days prior to screening) live attenuated vaccines.
14. Have active bacterial, fungal or detectable viral infection (e.g. Human Immunodeficiency Virus or Hepatitis B or Hepatitis C).

Contacts and Locations

Principal Investigator

Michael E Saunders, MD

STUDY_DIRECTOR

Onconova Therapeutics

Study Locations (Sites)

START Midwest

Grand Rapids, Michigan, 49546

United States

Greenville Health System, Institute for Oncology Clinical Research

Greenville, South Carolina, 29605

United States

Mary Crowley Cancer Research

Dallas, Texas, 75230

United States

Collaborators and Investigators

Sponsor: Traws Pharma, Inc.

Michael E Saunders, MD, STUDY_DIRECTOR, Onconova Therapeutics

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 Date2021-05-13

Study Completion Date2024-10

Study Record Updates

Study Start Date2021-05-13

Study Completion Date2024-10

Terms related to this study

Additional Relevant MeSH Terms

Solid Tumors, Adult