Is NCT04094610 recruiting in Orlando, FL?

Yes, NCT04094610 is currently enrolling participants at its Orlando, FL location. This cancer clinical trial is accepting qualified participants.

How do I join the cancer clinical trial in Orlando?

To join this clinical trial in Orlando, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Orlando clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Cancer Clinical Trial in Orlando, FL (Phase 1/2)

About This Cancer Study in Orlando

Phase 1 will evaluate the safety and tolerability at different dose levels of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring anaplastic lymphoma kinase (ALK), receptor tyrosine kinase encoded by the gene ROS1 (ROS1), or neurotrophic receptor kinase genes encoding TRK kinase family (NTRK1-3) alterations to estimate the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) and select the Pediatric Recommended Phase 2 Dose (RP2D). P

Sponsor: Turning Point Therapeutics, Inc.

Who Can Participate

Inclusion Criteria

Documented genetic ROS1 point mutation, fusion, or amplification or NTRK1-3 fusion as identified by local testing in a Clinical Laboratory Improvement Amendments (CLIA) laboratory in the US or equivalently accredited diagnostic lab outside the United States (US) is required.

Phase 1: Age \<12 years; Phase 2: Age 12- 25 years

Prior cytotoxic chemotherapy is allowed.

Prior immunotherapy is allowed.

Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1.

All subjects must have measurable disease by RECIST v1.1 or Response Assessment in Neuro-Oncology (RANO) criteria at time of enrollment.

Subjects with a primary CNS tumor or CNS metastases must be neurologically stable on a stable or decreasing dose of steroids for at least 7 days prior to enrollment.

Subjects must have a Lansky (\< 16 years) or Karnofsky (≥ 16 years) score of at least 50.

Life expectancy greater than or equal to 12 weeks, in the investigator's opinion.

Adequate hematologic, renal and hepatic function. Phase 2 Inclusion Criteria:

Cohort Specific Inclusion Criteria:

Cohort 1: Subjects with NTRK fusion gene positive (NTRK+) advanced solid tumors (including primary CNS tumors), that are tropomyosin receptor kinase (TRK) TKI naïve;

Cohort 2: subjects with NTRK+ advanced solid tumors (including primary CNS tumors), that are TRK TKI pre-treated;

Cohort 3: subjects with advanced solid tumors with ROS1 gene fusions or other ROS1 aberrations (including amplifications and point mutations) with measurable disease.

Subjects in Cohorts 1 and 2 must have prospectively confirmed measurable disease by BICR prior to enrollment. Key

Exclusion Criteria

(Phase 1 and Phase 2):

Subjects with neuroblastoma with only bone marrow disease evaluable by bone marrow aspiration only.

Major surgery within 14 days (2 weeks) of start of repotrectinib treatment. Central venous access (Broviac, Mediport, etc.) placement does not meet criteria for major surgery.

Known active infections requiring ongoing treatment (bacterial, fungal, viral including HIV positivity).

Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption.

Any of the following cardiac criteria:

Mean resting corrected QT interval (ECG interval measured from the onset of the QRS complex to the end of the T wave) for heart rate (QTc) \> 480 msec obtained from three ECGs, using the screening clinic ECG machine-derived QTc value

Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \> 250 msec)

Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong the QT interval

Peripheral neuropathy of CTCAE ≥grade 2.

Subjects being treated with or anticipating the need for treatment with strong CYP3A4 inhibitors or inducers.

Any potential allergies to repotrectinib and/or its excipients.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Orlando?

Yes, this clinical trial (NCT04094610) has an active research site in Orlando, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Cancer Treatment Options in Orlando, FL

If you're searching for cancer treatment options in Orlando, FL, this clinical trial (NCT04094610) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Orlando research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all cancer clinical trials near you to find additional studies recruiting in your area.

Cancer Clinical Trial in Orlando, FL

Expert Care in Orlando

IRB Approved

No-Cost Care

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