TK216 in Patients With Relapsed or Refractory Ewing Sarcoma

Phase 1

Terminated

• Conditions: Sarcoma, Ewing
• Interventions: Drug: TK216

• Registration Number: NCT02657005
• Lead Sponsor: Oncternal Therapeutics, Inc

Brief Summary

Ewing sarcoma is characterized by genomic rearrangements resulting in over-expression of ets family transcription factors driving tumor progression. TK216 is designed to inhibit this effect by inhibiting downstream effects of the EWS-FLI1 transcription factor. This study is a first in human study of TK216 in subjects with Ewing sarcoma. The study is designed to establish initial safety and efficacy data in monotherapy and in combination with vincristine to assess the potential of TK216 for further development.

Detailed Description

The study has been expanded to explore single agent TK216 for longer treatment duration. Approximately 26 patients will be enrolled in this Cohort.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations
|
Related News

Study Timeline

• Study First Submitted: 2016-01-12
• Study First Submitted QC: 2016-01-13
• Study First Posted: 2016-01-15
• Study Start: 2016-08
• Primary Completion: 2022-05
• Study Completion: 2022-06
• Results First Submitted: 2024-08-27
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-05
• Last Update Submitted: 2024-11-05
• Results First Posted: 2024-11-07
• Last Update Posted: 2024-11-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Patients will not be enrolled if they meet any one of the following exclusion criteria:

1. Current participation in another therapeutic clinical trial.

2. Symptomatic brain metastases.

3. History of previous cancer (non ES), except squamous cell or basal-cell carcinoma of the skin or any in situ carcinoma that has been completely resected, which required therapy within the previous 3 years.

4. Any of the following in the past 6 months: symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, symptomatic bradycardia, requirement for antiarrhythmic medication.

5. History of prolonged QTc interval (e.g., repeated demonstration of a QTc interval > 450 milliseconds, unless associated with the use of medications known to prolong the QTc interval). (NOTE: For Part 4, repeated demonstration of a QTc interval > 470 milliseconds) 6. History of additional risk factors for torsade de pointes (e.g., heart failure, family history of long QT syndrome

6. Use of concomitant medications that increase or possibly increase the risk to prolong the QTc interval and/or induce torsades de pointes ventricular arrhythmia.

7. Females who are breastfeeding/lactating. 9. Known active infections (bacterial, fungal, viral including hepatitis and HIV positivity). 10. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study or could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TK216 treatment	TK216	Dose escalation and expansion cohorts to determine dose-limiting toxicities, maximally tolerated dose, preliminary efficacy, and recommended phase 2 dose.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate	36 months	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions and pathologic lymph nodes; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions, no new lesions, and no progression of non-target lesions; Overall Response (OR) = CR + PR.

Trial Locations

Locations (9)

Duke Cancer Institute; 🇺🇸 Durham, North Carolina, United States

UCLA Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Texas Children's Cancer & Hematology Centers, Baylor College; 🇺🇸 Houston, Texas, United States

Children's Hospital of Colorado; 🇺🇸 Aurora, Colorado, United States

Children's National Hospital; 🇺🇸 Washington, District of Columbia, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

UT MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States