Restor. I-131 Upt. + Selpercatinib in RET F-P RAI-R TC

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Massachusetts General Hospital
Study ID
NCT05668962
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Follicular Thyroid Cancer
  • Metastatic Thyroid Cancer
  • Papillary Thyroid Cancer
  • Thyroid Cancer
  • Thyroid Carcinoma
  • Unresectable Thyroid Gland Carcinoma

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Selpercatinib — DRUG
    Selpercatinib Oral, twice daily during initial treatment period (28 Days). A second course of selpercatinib if the participant is demonstrating clinical benefit to the initial course selpercatinib and deemed clinically appropriate by the treating investigator
  • Sodium Iodine I-131 — DRUG
    I-131 NaI, oral, is a standard treatment for all types of follicular-derived thyroid cancers, except anaplastic thyroid cancer
  • rhTSH — DRUG
    RhTSH injection, dosage per protocol, timing per protocol during the initial treatment period per standard of care. Participants may receive a second course of rhTSH if the participant is demonstrating clinical benefit to the initial course rhTSH and deemed clinically appropriate by the treating investigator.

Study Details

This research is being done to determine the efficacy of selpercatinib to restore radioactive iodine (I-131 NaI) uptake and allow for I-131 treatment in people with RET fusion-positive radioiodine-refractory thyroid cancer. This research study involves the study drug selpercatinib in combination with standard of care treatments, I-131 and thyrotropin alfa (rhTSH).

Key Dates

Start date
Mar 1, 2023
Status verified
Oct 2024
Primary completion
Mar 1, 2025
Completion
Jan 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SELPERCATINIB + I-131 NaI
    The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. * Participants will be treated with Selpercatinib for 4 weeks. * In the fourth week of treatment, participants will receive a therapeutic dose of I-131 NaI. * Those participants in whom radioiodine uptake has been restored may be offered a second 4-week course of selpercatinib plus I-131 NaI treatment

Primary Outcome Measure

Objective Response Rate [ Time Frame: 6 Months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010
Kenneth Burman, MD
[email protected]
202-262-2206
Kenneth Burman, MD
Moffitt Cancer CenterTampaFlorida33612
Sarimar Agosto Salgado, MD
[email protected]
813-745-0561
Sarimar Agosto Salgado, MD
Massachusetts General HospitalBostonMassachusetts02115
Lori J Wirth, MD
[email protected]
617-724-1134
Lori J. Wirth, MD
University of MichiganAnn ArborMichigan48109
Frank Worden, MD
[email protected]
734-36-5281
Frank Worden, MD
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Theodore Laetsch, MD
[email protected]
267-425-5544
Theodore Laetsch, MD
MD Anderson Cancer CenterHoustonTexas77030
Steven Sherman, MD
[email protected]
713-792-2841

Find similar trials in Washington D.C., DC

By research site
MedStar Washington Hospital Center· Washington D.C., DCMoffitt Cancer Center· Tampa, FLMassachusetts General Hospital· Boston, MAUniversity of Michigan· Ann Arbor, MIChildren's Hospital of Philadelphia· Philadelphia, PAMD Anderson Cancer Center· Houston, TX

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