TK216 in Patients With Relapsed or Refractory Ewing Sarcoma
![]() |
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: NCT02657005 |
Recruitment Status :
Recruiting
First Posted : January 15, 2016
Last Update Posted : December 1, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sarcoma, Ewing | Drug: TK216 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 45 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1, Dose Escalation Study of Intravenous TK216 in Patients With Relapsed or Refractory Ewing Sarcoma |
Actual Study Start Date : | August 2016 |
Estimated Primary Completion Date : | March 2021 |
Estimated Study Completion Date : | June 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: TK216 treatment
Dose escalation and expansion cohorts to determine dose-limiting toxicities, maximally tolerated dose, preliminary efficacy, and recommended phase 2 dose.
|
Drug: TK216
Inhibitor of protein-protein interactions of EWS-FLI1 fusion protein |
- Dose-limiting toxicities (DLTs) [ Time Frame: 18 months ]Listing of dose-limiting toxicities by daily dose in mg/m^2
- Maximum tolerated dose (MTD) [ Time Frame: 18 months ]Maximum daily dose in mg/m^2
- Biologically effective and recommended Phase 2 dose (RP2D) [ Time Frame: 18 months ]Daily dose in mg/m^2
- Adverse Events [ Time Frame: 18 months ]
- Antitumor activity as measured by Overall Response Rate (ORR) [ Time Frame: 18 months ]
- Antitumor activity as measured by Duration of Response (DOR) [ Time Frame: 18 months ]
- Duration of Disease Control [ Time Frame: 18 months ]
- Assay methods to detect EWS-FLI1 (or EWS-ERG and EWS-ets) [ Time Frame: 18 months ]
- Pharmacokinetics: Maximum Plasma Concentration [Cmax] [ Time Frame: 18 months ]
- Pharmacokinetics: Area Under the Curve [AUC] [ Time Frame: 18 months ]
- Pharmacokinetics: Halflife [T1/2] [ Time Frame: 18 months ]
- Pharmacodynamics: serum miRNA profile [ Time Frame: 18 months ]
- Pharmacodynamics: tumor tissue RNA assays [ Time Frame: 18 months ]
- Pharmacodynamics: tumor tissue protein assays [ Time Frame: 18 months ]

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: | 10 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of Ewing sarcoma (including ESFT) in subjects with relapsed or refractory disease who have failed standard therapy
Exclusion Criteria:
- Symptomatic brain metastases

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): NCT02657005
Contact: Oncternal Information | 858-434-1113 | clinical@oncternal.com |
United States, California | |
UCLA Jonsson Comprehensive Cancer Center | Recruiting |
Los Angeles, California, United States, 90095 | |
Contact: Rubi Arias 310-794-0345 rubiarias@mednet.ucla.edu | |
Principal Investigator: Noah Federman, MD | |
United States, Colorado | |
Children's Hospital of Colorado | Recruiting |
Aurora, Colorado, United States, 80045 | |
Contact: Matthew O'hern, BS 720-777-8557 matthew.O'hern@childrenscolorado.org | |
Principal Investigator: Margaret Macy, MD | |
United States, District of Columbia | |
Children's National Hospital | Recruiting |
Washington, District of Columbia, United States, 20010 | |
Contact: Ann Liew, MS 202-476-6755 aliew@childrensnational.org | |
Principal Investigator: Aerang Kim, MD | |
United States, New York | |
Memorial Sloan Kettering Cancer Center | Recruiting |
New York, New York, United States, 10174 | |
Contact: Marilyn Winchester 646-888-5711 winchesm@mskcc.org | |
Contact: Melissa Leeolou 646-888-5717 leeoloum@mskcc.org | |
Principal Investigator: Paul A Meyers, MD | |
United States, North Carolina | |
Duke Cancer Institute | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Stephanie Weaver, RN, BSN 919-681-1883 stephanie.weaver@duke.edu | |
Contact: Lisa Hollon, RN, BSN 919-660-9217 lisa.hollon@duke.edu | |
Principal Investigator: Richard Riedel, MD | |
United States, Ohio | |
Cleveland Clinic Foundation | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Peter Anderson, MD, PhD 216-308-2706 andersp@ccf.org | |
Principal Investigator: Peter Anderson, MD, PhD | |
United States, Oregon | |
Oregon Health & Science University | Recruiting |
Portland, Oregon, United States, 97239 | |
Contact: Phil Norr 503-494-0825 norr@ohsu.edu | |
Principal Investigator: Lara Davis, MD | |
United States, Texas | |
Texas Children's Cancer & Hematology Centers, Baylor College | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Kathy McCarthy, RN 832-824-4804 ksmccart@txch.org | |
Principal Investigator: Jade Wulff, MD | |
UT MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Joseph A Ludwig, MD 713-792-3626 | |
Contact: Gracy Zacharian 713-792-2669 gzachari@mdanderson.org | |
Principal Investigator: Joseph A Ludwig, MD |
Study Director: | James Breitmeyer, MD | Oncternal Therapeutics |
Responsible Party: | Oncternal Therapeutics, Inc |
ClinicalTrials.gov Identifier: | NCT02657005 |
Other Study ID Numbers: |
TK216-01 |
First Posted: | January 15, 2016 Key Record Dates |
Last Update Posted: | December 1, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Sarcoma Sarcoma, Ewing Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Osteosarcoma Neoplasms, Bone Tissue |
Neoplasms, Connective Tissue Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |