TK216 in Patients With Relapsed or Refractory Ewing Sarcoma
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 10 - Any |
| Updated: | 2/24/2019 |
| Start Date: | August 2016 |
| End Date: | September 2019 |
| Contact: | Xen Ianopulos, MD |
| Email: | xengia@oncternal.com |
| Phone: | 206-434-0133 |
A Phase 1, Dose Escalation Study of Intravenous TK216 in Patients With Relapsed or Refractory Ewing Sarcoma
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.
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.
TK216 is administered as a continuous intravenous infusion over 7-21 days depending on the
dosing group. Administration is in cycles with a 14 day resting period between cycles. In the
dose escalation segment of the study vincristine can be added after completion of 2 cycles of
treatment with TK216 alone. After a "recommended phase 2 dose" has been determined in the
dose escalation segment an expansion cohort will be initiated. In the expansion cohort
combination treatment of TK216 and vincristine will start with cycle 1.
dosing group. Administration is in cycles with a 14 day resting period between cycles. In the
dose escalation segment of the study vincristine can be added after completion of 2 cycles of
treatment with TK216 alone. After a "recommended phase 2 dose" has been determined in the
dose escalation segment an expansion cohort will be initiated. In the expansion cohort
combination treatment of TK216 and vincristine will start with cycle 1.
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
We found this trial at
6
sites
1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Principal Investigator: Paul A Meyers, MD
Phone: 646-888-5711
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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20 Duke Clinic Cir
Durham, North Carolina 27710
Durham, North Carolina 27710
(888) 275-3853
Principal Investigator: Richard Riedel, MD
Phone: 919-681-1883
Duke Cancer Institute Leading-edge cancer care and research have been a hallmark of Duke Medicine...
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Houston, Texas 77030
Principal Investigator: Joseph A Ludwig, MD
Phone: 713-792-3626
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Houston, Texas 77030
Principal Investigator: Jodi A Muscal, MD
Phone: 832-824-4804
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Los Angeles, California 90095
Principal Investigator: Noah Federman, MD
Phone: 310-794-8086
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