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A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001) (LIBRETTO-001)

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: NCT03157128
Recruitment Status : Recruiting
First Posted : May 17, 2017
Last Update Posted : June 23, 2022
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company ( Loxo Oncology, Inc. )

Brief Summary:
This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of selpercatinib (also known as LOXO-292) administered orally to participants with advanced solid tumors, including rearranged during transfection (RET)-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Medullary Thyroid Cancer Colon Cancer Any Solid Tumor Drug: LOXO-292 Phase 1 Phase 2

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Detailed Description:

This is an open-label, multi-center Phase 1/2 study in participants with advanced solid tumors, including RET fusion-positive solid tumors, MTC, and other tumors with RET activation. The trial will be conducted in 2 parts: Phase 1 (dose escalation - completed) and phase 2 (dose expansion). Participants with advanced cancer are eligible if they have progressed on or are intolerant to available standard therapies, or no standard or available curative therapy exists, or in the opinion of the Investigator, they would be unlikely to tolerate or derive significant clinical benefit from appropriate standard of care therapy, or they declined standard therapy. A dose of 160 milligrams (mg) twice a day (BID) has been selected as the recommended phase 2 dose (RP2D). Approximately 950 participants with advanced solid tumors harboring a RET gene alteration in tumor and/or blood will be enrolled to one of seven phase 2 cohorts:

  • Cohort 1: Advanced RET fusion positive solid tumor for participants who progressed on or intolerant to first line therapy (open)
  • Cohort 2: Advanced RET fusion positive solid tumor for treatment naïve participants (open)
  • Cohort 3: Advanced RET-mutant MTC participants who progressed on or intolerant to first line therapy (closed)
  • Cohort 4: Advanced RET-mutant MTC participants who are treatment naïve (closed)
  • Cohort 5: Advanced RET-altered solid tumor for participants otherwise ineligible for cohorts 1-4. See details in inclusion/exclusion criteria (open)
  • Cohort 6: Participants otherwise eligible for Cohorts 1-5 who discontinued another RET inhibitor due to intolerance may be eligible with prior Sponsor approval (open)
  • Cohort 7: RET fusion positive early-stage non-small cell lung cancer (NSCLC) participants who are candidates for definitive surgery. Participants will receive selpercatinib in a neoadjuvant and adjuvant setting. Participants will be followed for disease recurrence for up to 5 years from the date of surgery (open)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 989 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of Oral Selpercatinib (LOXO-292) in Patients With Advanced Solid Tumors, Including RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors With RET Activation (LIBRETTO-001)
Actual Study Start Date : May 2, 2017
Estimated Primary Completion Date : November 21, 2022
Estimated Study Completion Date : November 21, 2023


Arm Intervention/treatment
Experimental: LOXO-292
Phase 1 - Multiple doses of LOXO-292 (selpercatinib) Phase 2 - The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D)
Drug: LOXO-292
Oral LOXO-292
Other Names:
  • Selpercatinib
  • LY3527723




Primary Outcome Measures :
  1. Phase 1: MTD [ Time Frame: The first 28 days of treatment (Cycle 1) ]
    Incidence rate and category of dose limiting toxicities (DLTs) during the first 28-day cycle of LOXO-292 (selpercatinib) treatment

  2. Phase 1: RP2D [ Time Frame: The first 28 days of treatment (Cycle 1) and every cycle (28 days) for approximately 12 months (or earlier if the participant discontinues from the study) ]
    Phase 1: RP2D

  3. Phase 2: Objective Response Rate [ Time Frame: Approximately every 8 weeks for one year, then every 12 weeks, and 7 days after the last dose (for up to 2 years) in participants who have not progressed. ]
    As assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Response Assessment in Neuro-Oncology (RANO), as appropriate to tumor type, as assessed by independent review committee (IRC)


Secondary Outcome Measures :
  1. Phase 1: Number of Participants with a Treatment-Related Adverse Event(s) (TRAE[s]) [ Time Frame: From the time of informed consent, for approximately 24 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose) ]
    Phase 1: Number of Participants with a TRAE(s)

  2. Phase 1: Number of Participants with an Abnormal Laboratory or Physical Exam Result(s) [ Time Frame: From the time of informed consent, for approximately 24 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose) ]
    Phase 1: Number of Participants with an Abnormal Laboratory or Physical Exam Result(s)

  3. Phase 1: Overall Response Rate (ORR) based on RECIST 1.1 or RANO, as Appropriate to Tumor Type [ Time Frame: Approximately every 8 weeks for one year, then every 12 weeks, 7 days after the last dose (for up to 2 years) in participants who have not progressed ]
    Phase 1: ORR based on RECIST 1.1 or RANO, as Appropriate to Tumor Type

  4. Phase 2: ORR (by Investigator) [ Time Frame: Approximately every 8 weeks for one year, then every 12 weeks, 7 days after the last dose (for up to 2 years) in participants who have not progressed ]
    Phase 2: ORR (by Investigator)

  5. Phase 2: Best Change in Tumor Size from Baseline (by IRC and Investigator) [ Time Frame: Approximately every 8 weeks for one year, then every 12 weeks, 7 days after the last dose (for up to 2 years) in participants who have not progressed ]
    Phase 2: Best Change in Tumor Size from Baseline (by IRC and Investigator)

  6. Phase 2: Duration of Response (DOR; by IRC and Investigator) [ Time Frame: Approximately every 8 weeks for one year, then every 12 weeks, 7 days after the last dose (for up to 2 years) in participants who have not progressed ]
    Phase 2: DOR (by IRC and Investigator)

  7. Phase 2: Central Nervous System (CNS) ORR (by IRC) [ Time Frame: Approximately every 8 weeks for one year, then every 12 weeks, 7 days after the last dose (for up to 2 years) in participants who have not progressed ]
    Phase 2: CNS ORR (by IRC)

  8. Phase 2: CNS DOR (by IRC) [ Time Frame: Approximately every 8 weeks for one year, then every 12 weeks, 7 days after the last dose (for up to 2 years) in participants who have not progressed ]
    Phase 2: CNS DOR (by IRC)

  9. Phase 2: Time to Any and Best Response (by IRC and Investigator) [ Time Frame: every 8 weeks for one year, then every 12 weeks, 7 days after the last dose (for up to 2 years) in participants who have not progressed ]
    Phase 2: Time to Any and Best Response (by IRC and Investigator)

  10. Phase 2: CBR (by IRC and Investigator) [ Time Frame: Approximately every 8 weeks for one year, then every 12 weeks, 7 days after the last dose (for up to 2 years) in participants who have not progressed ]
    Phase 2: CBR (by IRC and Investigator)

  11. Phase 2: PFS (by IRC and Investigator) [ Time Frame: Approximately every 8 weeks for one year, then every 12 weeks, 7 days after the last dose (for up to 2 years) in participants who have not progressed ]
    Phase 2: PFS (by IRC and Investigator)

  12. Phase 2: Overall Survival (OS) [ Time Frame: Approximately every 8 weeks for one year, then every 12 weeks, 7 days after the last dose (for up to 2 years) in participants who have not progressed ]
    Phase 2: OS

  13. Phase 2: Percentage of Participants with any Serious Adverse Event (SAE[s]) [ Time Frame: From the time of informed consent, for approximately 24 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose) ]
    Phase 2: Percentage of Participants with any SAE(s)

  14. Phase 1 and 2: Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve of LOXO-292 (Selpercatinib) [ Time Frame: Cycle 1 Day 1 through Cycle 5 Day 1 (Cycle = 28 days) ]
    Phase 1 and 2: PK: AUC of LOXO-292 (Selpercatinib)

  15. Phase 1 and 2: PK: Maximum Concentration (Cmax) of LOXO-292 (Selpercatinib) [ Time Frame: Cycle 1 Day 1 through Cycle 5 Day 1 (Cycle = 28 days) ]
    Phase 1 and 2: PK: Cmax of LOXO-292 (Selpercatinib)



Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

For Phase 1:

  • Participants with a locally advanced or metastatic solid tumor that:
  • Has progressed on or is intolerant to standard therapy, or
  • For which no standard therapy exists, or in the opinion of the Investigator, are not candidates for or would be unlikely to tolerate or derive significant clinical benefit from standard therapy, or
  • Decline standard therapy
  • Prior multikinase inhibitors (MKIs) with anti-RET activity are allowed
  • A RET gene alteration is not required initially. Once adequate PK exposure is achieved, evidence of RET gene alteration in tumor and/or blood is required as identified through molecular assays, as performed for clinical evaluation
  • Measurable or non-measurable disease as determined by RECIST 1.1 or RANO as appropriate to tumor type
  • Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2 or Lansky Performance Score (LPS) greater than or equal to (≥) 40 percent (%) (age less than [<] 16 years) with no sudden deterioration 2 weeks prior to the first dose of study treatment
  • Adequate hematologic, hepatic and renal function
  • Life expectancy of at least 3 months

For Phase 2: As for phase 1 with the following modifications:

  • For Cohort 1: Participants must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinical benefit from appropriate standard of care therapy
  • Cohorts 1 and 2:

    • Enrollment will be restricted to participants with evidence of a RET gene alteration in tumor
    • At least one measurable lesion as defined by RECIST 1.1 or RANO, as appropriate to tumor type and not previously irradiated
  • Cohorts 3 and 4: Enrollment closed
  • Cohort 5:

    • Cohorts 1-4 without measurable disease
    • MCT not meeting the requirements for Cohorts 3 or 4
    • MTC syndrome spectrum cancers (e.g., MTC, pheochromocytoma), cancers with neuroendocrine features/differentiation, or poorly differentiated thyroid cancers with other RET alteration/activation may be allowed with prior Sponsor approval
    • cfDNA positive for a RET gene alteration not known to be present in a tumor sample
  • Cohort 6: Participants who otherwise are eligible for Cohorts 1, 2 or 5 who discontinued another RET inhibitor may be eligible with prior Sponsor approval
  • Cohort 7: Participants with a histologically confirmed stage IB-IIIA NSCLC and a RET fusion; determined to be medically operable and tumor deemed resectable by a thoracic surgical oncologist, without prior systemic treatment for NSCLC

Key Exclusion Criteria (Phase 1 and Phase 2):

  • Phase 2 Cohorts 1 and 2: an additional known oncogenic driver
  • Cohorts 3 and 4: Enrollment closed
  • Cohorts 1, 2 and 5: prior treatment with a selective RET inhibitor Notes: Participants otherwise eligible for Cohorts 1, 2, and 5 who discontinued another selective RET inhibitor may be eligible for Phase 2 Cohort 6 with prior Sponsor approval
  • Investigational agent or anticancer therapy (including chemotherapy, biologic therapy, immunotherapy, anticancer Chinese medicine or other anticancer herbal remedy) within 5 half-lives or 2 weeks (whichever is shorter) prior to planned start of LOXO-292 (selpercatinib). In addition, no concurrent investigational anti-cancer therapy is permitted Note: Potential exception for this exclusion criterion will require a valid scientific justification and approval from the Sponsor
  • Major surgery (excluding placement of vascular access) within 2 weeks prior to planned start of LOXO-292 (selpercatinib)
  • Radiotherapy with a limited field of radiation for palliation within 1 week of planned start of LOXO-292 (selpercatinib), with the exception of participants receiving radiation to more than 30% of the bone marrow or with a wide field of radiation, which must be completed at least 4 weeks prior to the first dose of study treatment
  • Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy
  • Symptomatic primary CNS tumor, metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression. Participants are eligible if neurological symptoms and CNS imaging are stable and steroid dose is stable for 14 days prior to the first dose of LOXO-292 (selpercatinib) and no CNS surgery or radiation has been performed for 28 days, 14 days if stereotactic radiosurgery (SRS)
  • Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of LOXO-292 (selpercatinib) or prolongation of the QT interval corrected (QTcF) greater than (>) 470 milliseconds (msec)

    • Participants with implanted pacemakers may enter the study without meeting QTc criteria due to nonevaluable measurement if it is possible to monitor for QT changes.
    • Participants with bundle branch block may be considered for study entry if QTc is appropriate by a formula other than Fridericia's and if it is possible to monitor for QT changes.
  • Required treatment with certain strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers and certain prohibited concomitant medications
  • Phase 2 Cohort 7 (neoadjuvant treatment): Participant must not have received prior systemic therapy for NSCLC.

Information from the National Library of Medicine

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): NCT03157128


Contacts
Layout table for location contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
Hide Hide 85 study locations
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United States, Arizona
Mayo Clinic of Scottsdale Recruiting
Scottsdale, Arizona, United States, 85259
Contact    480-301-8000      
Principal Investigator: Nina J Karlin         
United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010-0269
Contact    818-359-8111      
Principal Investigator: Erminia Massarelli         
University of California - San Diego Recruiting
La Jolla, California, United States, 92161
Contact    858-822-6189      
Principal Investigator: Lyudmila Bazhenova         
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact    310-794-1816      
Principal Investigator: Jonathan W Goldman         
Hoag Memorial Hospital Presbyterian Not yet recruiting
Newport Beach, California, United States, 92663
Contact    949-761-6767      
Principal Investigator: Michael Demeure         
Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact    714-456-8105      
Principal Investigator: Misako Nagasaka         
UCSF Medical Center at Mission Bay Recruiting
San Francisco, California, United States, 94115
Contact    415-885-3882      
Principal Investigator: Hyunseok Kang         
Kaiser Permanente Recruiting
Santa Clara, California, United States, 95051
Contact    708-851-9588      
Principal Investigator: Minggui Pan         
Kaiser Permanente Medical Center Recruiting
Vallejo, California, United States, 94589
Contact    5108913414      
Principal Investigator: Jennifer Marie Suga         
United States, Colorado
Sarah Cannon Research Institute at HealthOne Recruiting
Denver, Colorado, United States, 80218
Contact    720-754-2610      
Principal Investigator: Gerald S Falchook         
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06510
Contact    203-737-5234      
Principal Investigator: Frederick H Wilson         
United States, District of Columbia
Johns Hopkins University Recruiting
Washington, District of Columbia, United States, 20016
Contact    202-660-6500      
Principal Investigator: Benjamin Levy         
United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact    904-953-2224      
Principal Investigator: Victor Bernet         
Memorial Hospital Pembroke Recruiting
Pembroke, Florida, United States, 33028
Contact    954-265-4325      
Principal Investigator: Luis Raez         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact    404-778-5378      
Principal Investigator: Conor Steuer         
United States, Illinois
University of Chicago Medicine-Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637
Principal Investigator: Christine M Bestvina         
United States, Louisiana
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact    504-842-3910      
Principal Investigator: Marc R Matrana         
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact    410-328-8708      
Principal Investigator: Christian Rolfo         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact    617-726-2000      
Principal Investigator: Lori Wirth         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact    617-632-2307      
Principal Investigator: Jacob Sands         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact    734-764-1817      
Principal Investigator: Francis Worden         
START Midwest Recruiting
Grand Rapids, Michigan, United States, 49546
Contact    616-954-5554      
Principal Investigator: Nehal Lakhani         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact    5072844080      
Principal Investigator: John Columbus Morris         
United States, Missouri
Washington University Medical School Recruiting
Saint Louis, Missouri, United States, 63110
Contact    314-362-7229      
Principal Investigator: Saiama N Waqar         
United States, Nevada
Comprehensive Cancer Centers of Nevada Not yet recruiting
Las Vegas, Nevada, United States, 89169
Contact    702-952-3400      
Principal Investigator: Fadi S Braiteh         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263-0002
Contact    716-845-3099      
Principal Investigator: Grace Dy         
NYU Langone Recruiting
New York, New York, United States, 10016
Contact    212-731-5662      
Principal Investigator: Vamsidhar Velcheti         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact    646-888-4206      
Principal Investigator: Alexander Drilon         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599-7305
Contact    866-869-1856      
Principal Investigator: Jared Weiss         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact    216-444-1128      
Principal Investigator: Nathan Pennell         
Ohio State University Hospital Recruiting
Columbus, Ohio, United States, 43210
Contact    614-293-4680      
Principal Investigator: Manisha H Shah         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact    503-494-8534      
Principal Investigator: Kyaw Z Thein         
United States, Pennsylvania
University of Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact    215-746-6344      
Principal Investigator: Devraj Basu         
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Principal Investigator: Marcia Brose         
United States, Tennessee
Sarah Cannon Research Institute SCRI Recruiting
Nashville, Tennessee, United States, 37203
Principal Investigator: Todd Michael Bauer         
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232-6307
Contact    6159368580      
Principal Investigator: Jordan David Berlin         
United States, Texas
University of Texas Southwestern Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75390-9063
Contact    214-648-4180      
Principal Investigator: Tian Zhang         
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact    713-745-6754      
Principal Investigator: Vivek Subbiah         
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact    801-585-5986      
Principal Investigator: Wallace L Akerley         
United States, Virginia
Virginia Cancer Specialists, PC Recruiting
Fairfax, Virginia, United States, 22031
Contact    703-280-5390      
Principal Investigator: Alexander I Spira         
United States, Wisconsin
University of Wisconsin-Madison Hospital and Health Clinic Recruiting
Madison, Wisconsin, United States, 53792
Contact    608-262-2803      
Principal Investigator: Mark Burkard         
Australia, New South Wales
Royal North Shore Hospital Recruiting
St. Leonards, New South Wales, Australia, 2065
Contact    61299267267      
Principal Investigator: Bruce Robinson         
Australia, Victoria
Peter MacCallum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 3000
Contact    61385595000      
Principal Investigator: Benjamin Solomon         
Canada, British Columbia
BC Cancer Vancouver Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact    6048776000      
Principal Investigator: Janessa Laskin         
Denmark
Rigshospitalet Recruiting
Copenhagen, København Ø, Denmark, 2100
Contact    004535456353      
Principal Investigator: Kristoffer Rohrberg         
France
Hôpital Européen Georges Pompidou Recruiting
Paris, Cedex 15, France, 75908
Contact    33156093714      
Principal Investigator: Jacques Medioni         
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest Recruiting
Bordeaux, France, 33076
Contact    556333244      
Principal Investigator: Antoine Italiano         
Centre Leon Berard Recruiting
Lyon Cedex 08, France, 69373
Contact    33426556833      
Principal Investigator: Philippe Cassier         
APHM Hôpital de la Timone Recruiting
Marseille, France, 13385
Contact    33491385918      
Principal Investigator: Pascale Tomasini         
Institut du Cancer de Montpellier - Val d'aurelle Not yet recruiting
Montpellier Cedex 5, France, 34298
Contact    33467613100      
Principal Investigator: Diego Tosi         
Gustave Roussy Recruiting
Villejuif Cedex, France, 94805
Contact    33142114157      
Principal Investigator: Benjamin Besse         
Germany
Universitätsklinikum Würzburg A. ö. R. Recruiting
Würzburg, Bayern, Germany, 97080
Contact    4993120139939      
Principal Investigator: Barbara Deschler-Baier         
Universitätsklinikum Köln Recruiting
Köln, Nordrhein-Westfalen, Germany, 50937
Contact    492214783993      
Principal Investigator: Jürgen Wolf         
Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Shatin, New Territories, Hong Kong
Contact    85226322648      
Principal Investigator: Herbert Ho Fung Loong         
Israel
Sheba Medical Center Recruiting
Tel Hashomer, Ramat Gan, Israel, 5265601
Contact    972526667591      
Principal Investigator: Talia Golan         
Shaare Zedek Medical Center Not yet recruiting
Jerusalem, Yerushalayim, Israel, 9103102
Principal Investigator: Nir Peled         
Soroka Medical Center - Pediatric Outpatient Clinic Recruiting
Beer-Sheva, Israel, 8410101
Contact    972587040620      
Principal Investigator: Julia Dudnik         
Hadassah Medical Center Recruiting
Jerusalem, Israel, 91120
Contact    972508946057      
Principal Investigator: Hovav Nechushtan         
Italy
Istituto Nazionale dei Tumori Recruiting
Milano, Lombardie, Italy, 20133
Contact    390223902906      
Principal Investigator: Filippo De Braud         
Japan
Nagoya University Hospital Recruiting
Nagoya, Aichi, Japan, 466-8560
Contact    81527412111      
Principal Investigator: Masahiro Morise         
National Cancer Center Hospital East Recruiting
Kashiwa, Chiba, Japan, 277-8577
Contact    81471331111      
Principal Investigator: Koichi Goto         
Hokkaido University Hospital Recruiting
Sapporo, Hokkaido, Japan, 060-8648
Contact    81 117161161      
Principal Investigator: Jun Sakakibara         
Hyogo Cancer Center Recruiting
Akashi, Hyogo, Japan, 673-8558
Contact    81789291151      
Principal Investigator: Miyako Satouchi         
Kanazawa University Hospital Recruiting
Kanazawa, Ishikawa, Japan, 920-8641
Contact    81762652000      
Principal Investigator: Shinji Takeuchi         
Kindai University Hospital Recruiting
Osaka Sayama-shi, Osaka, Japan, 589 8511
Contact    81723660221      
Principal Investigator: Tsutomu Iwasa         
Shizuoka Cancer Center Recruiting
Nagaizumi, Shizuoka, Japan, 411-8777
Contact    81559895222      
Principal Investigator: Hirotsugu Kenmotsu         
National Cancer Center Hospital Recruiting
Chuo-ku, Tokyo, Japan, 104-0045
Contact    81335422511      
Principal Investigator: YUICHIRO OHE         
Japanese Foundation for Cancer Research Recruiting
Koto, Tokyo, Japan, 135-8550
Contact    81335200111      
Principal Investigator: Makoto Nishio         
Tottori University Hospital Recruiting
Yonago, Tottori, Japan, 683-8504
Contact    81859331111      
Principal Investigator: Tomohiro Sakamoto         
National Hospital Organization Kyushu Cancer Center Recruiting
Fukuoka, Japan, 811-1395
Contact    81925413231      
Principal Investigator: Ryo Toyozawa         
Okayama University Hospital Recruiting
Okayama, Japan, 700-8558
Contact    81862357226      
Principal Investigator: Kadoaki Ohashi         
Osaka City General Hospital Recruiting
Osaka, Japan, 534-0021
Contact    81669291221      
Principal Investigator: Haruko Daga         
Korea, Republic of
National Cancer Center Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
Contact    82319201154      
Principal Investigator: Ji-Youn Han         
Seoul National University Bundang Hospital Recruiting
Seongnam, Kyǒnggi-do, Korea, Republic of, 13620
Contact    82317877005      
Principal Investigator: Yu Jung Kim         
Asan Medical Center Recruiting
Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 05505
Contact    8222243214      
Principal Investigator: Dae Ho Lee         
Samsung Medical Center Recruiting
Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06351
Contact    82234101132      
Principal Investigator: Se Hoon Lee         
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
Contact    82222280880      
Principal Investigator: Byoung Chul Cho         
Singapore
National Cancer Centre Singapore Recruiting
Singapore, Singapore, 169610
Contact    6564368000      
Principal Investigator: Shao Weng Daniel Tan         
Spain
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Barcelona [Barcelona], Spain, 8035
Contact    934893000      
Principal Investigator: Elena Garralda Cabanas         
Hospital Universitario Fundación Jiménez Díaz Recruiting
Madrid, Spain, 28040
Contact    34915504800      
Principal Investigator: Victor Moreno         
Hospital Madrid Norte Sanchinarro Recruiting
Madrid, Spain, 28050
Contact    917567800      
Principal Investigator: Valentina Boni         
Switzerland
Kantonsspital Luzern Recruiting
Luzern 16, Luzern, Switzerland, 6000
Contact    0041412056849      
Principal Investigator: Oliver Gautschi         
Taiwan
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 40705, ROC
Contact    886423592525      
Principal Investigator: Kuo-Hsuan Hsu         
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Contact    8862231245665339      
Principal Investigator: Chih-Hsin Yang         
United Kingdom
Royal Marsden Hospital Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact    02086426011      
Principal Investigator: Anna Minchom         
Sponsors and Collaborators
Loxo Oncology, Inc.
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Loxo Oncology, Inc.
ClinicalTrials.gov Identifier: NCT03157128    
Other Study ID Numbers: 17477
J2G-OX-JZJA ( Other Identifier: Eli Lilly and Company )
LOXO-RET-17001 ( Other Identifier: Loxo Oncology, Inc. )
2017-000800-59 ( EudraCT Number )
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: June 23, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company ( Loxo Oncology, Inc. ):
LOXO-292
KIF5B-RET
M918T
CCDC6-RET
RET-PTC1
NCOA4-RET
RET-PTC
RET-PTC3
RET-PTC4
PRKAR1A-RET
RET-PTC2
GOLGA5-RET
RET-PTC5
ERC1-RET
KTN1-RET
RET-PTC8
HOOK3-RET
PCM1-RET
TRIM24-RET
RET-PTC6
TRIM27-RET
TRIM33-RET
RET-PTC7
AKAP13-RET
FKBP15-RET
SPECC1L-RET
TBL1XR1-RET
BCR-RET
FGRF1OP-RET
RFG8-RET
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Colonic Neoplasms
Thyroid Neoplasms
Carcinoma, Neuroendocrine
Thyroid Diseases
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Endocrine System Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Endocrine Gland Neoplasms
Head and Neck Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Adenocarcinoma