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New pill targets rare cancer drivers in chinese patients

NCT ID NCT04280081

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This phase 2 study tests an oral drug called selpercatinib in 77 people in China who have advanced solid tumors or medullary thyroid cancer with specific RET gene changes. The goal is to see if the drug can shrink tumors and how safe it is. Participants take the pill daily, and doctors monitor their response using standard cancer measurement criteria.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Selpercatinib (a targeted oral drug that blocks RET proteins driving cancer growth)
What this could lead to
If successful, this could provide a new treatment option for people in China with certain RET-altered cancers, potentially shrinking tumors and delaying progression.
What could go wrong
This is a mid-stage trial with only 77 participants, so results may not apply broadly. Selpercatinib can cause side effects like liver issues, high blood pressure, and fatigue, and not all patients may respond.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

77 people

The number who actually took part.

Started

Mar 2020

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants with a locally advanced or metastatic solid tumor. * Evidence of a RET gene alteration in tumor and/or blood. * Measurable or non-measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2, with no sudden deterioration 2 weeks prior to the first dose of study treatment. * Archived tumor tissue sample available for cohort 1 and 2. * Cohorts 1 and 2: failed or intolerant to standard of care. * Cohorts 1-2: enrollment will be restricted to participants with evidence of a RET gene alteration in tumor (i.e., not just blood). However, a positive germline DNA test for a RET gene mutation as defined in the protocol is acceptable in the absence of tumor tissue testing for participants with MTC. * Cohorts 1-2: at least one measurable lesion as defined by RECIST v1.1 and not previously irradiated (unless progressive disease for the irradiated lesion\[s\] has been radiographically documented). Exclusion Criteria: * Cohorts 1-2, an additional validated oncogenic driver that could cause resistance to selpercatinib treatment if known. * Prior treatment with a selective RET inhibitor(s) (including investigational selective RET inhibitor(s), such as BLU-667, RXDX-105, etc). * Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study. * Any unresolved toxicities from prior therapy greater than common terminology criteria for adverse events (CTCAE) Grade 1 except where otherwise noted in this eligibility criteria at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum therapy-related neuropathy. * Symptomatic primary central nervous system (CNS) tumor, symptomatic CNS metastasis, leptomeningeal carcinomatosis, or untreated spinal cord compression. * Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of selpercatinib or prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) \> 470 milliseconds. * History of Human Immunodeficiency Virus (known HIV 1/2 antibodies positive); participants with unknown HIV status do not need to be tested. * History of active hepatitis B (known positive hepatitis B surface antigen \[HbsAg\] and quantitative hepatitis B DNA greater than the upper limit of detection of the assay) or C (known positive hepatitis C antibody and quantitative hepatitis C RNA greater than the upper limit of detection of the assay); participants with unknown hepatitis B/hepatitis C status do not need to be tested. * Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment. Screening for chronic conditions is not required. * Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug. * Uncontrolled symptomatic hyperthyroidism or hypothyroidism * Uncontrolled symptomatic hypercalcemia or hypocalcemia. * Concurrent use of drugs known to prolong QTc. * Pregnancy or lactation. Breast-feeding should be interrupted when selpercatinib is started; breast-feeding can be resumed 3 months after discontinuation of selpercatinib. * Active second malignancy other than minor treatment of indolent cancers with prior sponsor approval.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032, China

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013, China

  • Jilin Cancer Hospital

    Changchun, Jilin, 130000, China

  • Jinan Central Hospital

    Jinan, Shandong, 250013, China

  • Shanghai Chest Hospital

    Shanghai, Shanghai/China, 200030, China

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200120, China

  • Southern Medical University Nanfang Hospital

    Guangzhou, Guangdong, 510515, China

  • The First Affiated Hospital Of Guangzhou Medical University

    Guangzhou, Guangdong, 510120, China

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang, 310003, China

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014, China

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