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ZD6474 (vandetanib)

Clinical Sciences & Operations

This will be a Phase II, open label study to establish the effect of once-daily oral doses of ZD6474 100mg in subjects with locally advanced or metastatic hereditary medullary thyroid cancer in whom no standard therapeutic option is available.

A Study To Assess ZD6474 (ZACTIMA™) Monotherapy In Locally Advanced or Metastatic Hereditary Medullary Thyroid Cancer

A Phase II, Open-Label Study To Assess The Efficacy and Tolerability of ZD6474 (ZACTIMA™ ) 100 mg Monotherapy In Subjects With Locally Advanced or Metastatic Hereditary Medullary Thyroid Cancer

The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria.

The categories for best objective response are CR, PR, stable disease (SD)\>= 12 weeks, progressive disease (PD) or NE.

Median progression free survival (months) estimated from a Weibull model with corresponding 95% confidence intervals. Progression free survival is the time from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment.

Disease control rate is defined as the number of patients who achieved disease control at 8 weeks following randomisation. Disease control at 8 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) \>= 24 weeks

Number of patients demonstrating an improvement from baseline to 24 weeks in WHO PS. Where WHO PS is the standard scale with patients scored (0 healthy - 5 dead) based on their physical capabilities

Symptomatic response will be defined as at least a 50% decrease in the stool frequency (represented by a persistent decrease in stool frequency over 4 weeks), taking as reference the baseline (mean) level.

A patient's best biochemical response was calculated from assessments performed at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met.

A patient's best biochemical response was calculated from assessments performed at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for Partial Response (PR) or Complete Response (CR) were first met.

Genzyme, a Sanofi Company

ZD6474 (ZACTIMA™) 100 mg

Age, Continuous

Gender

Trial Transparency Team

Objective Response Rate (ORR)

Progression-Free Survival (PFS)

Disease Control Rate (DCR)

World Heath Organization (WHO) Performance Status

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Biochemical Response Calcitonin (CTN )

Biochemical Response Carcinoembryonic Antigen CEA)

Overall Study

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Cola

Phase 1 - Multiple doses of LOXO-292 (selpercatinib) Phase 2 - The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D)

LOXO-292

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Nina Karlin

Erminia Massarelli

Lyudmila Bazhenova

Jonathan Goldman

Michael Demeure

Misako Nagasaka

Hyunseok Kang

Minggui Pan

Jennifer Suga

Gerald Falchook

Frederick Wilson

Benjamin Levy

Victor Bernet

Luis Raez

Conor Steuer

Christine Bestvina

Marc Matrana

Ranee Mehra

Lori Wirth

Jacob Sands

Francis Worden

Nehal Lakhani

John Columbus Morris

Saiama Waqar

Fadi Braiteh

Grace Dy

Vamsidhar Velcheti

Alexander Drilon

Jared Weiss

Nathan Pennell

Vineeth Sukrithan

Shivaani Kummar

Devraj Basu

Marcia Brose

Jordan Berlin

Tian Zhang

Vivek Subbiah

Wallace Akerley

Alexander Spira

Mark Burkard

bruce robinson

Benjamin Solomon

Janessa Laskin

Kristoffer Rohrberg

Jacques Medioni

Antoine Italiano

Philippe Cassier

Pascale Tomasini

Diego Tosi

Benjamin Besse

Barbara Deschler-Baier

Jürgen Wolf

Herbert Loong

Talia Golan

Nir Peled

Julia Dudnik

Hovav Nechushtan

Filippo De Braud

Masahiro Morise

Koichi Goto

Jun Sakakibara

Miyako Satouchi

Shinji Takeuchi

Tsutomu Iwasa

Hirotsugu Kenmotsu

YUICHIRO OHE

Makoto Nishio

Tomohiro Sakamoto

Ryo Toyozawa

Kadoaki Ohashi

Haruko Daga

Ji-Youn Han

Yu Jung Kim

Dae Ho Lee

Se Hoon Lee

Byoung Chul Cho

Shao Weng Daniel Tan

Elena Garralda Cabanas

Victor Moreno

Maria Jose de Miguel Luken

Oliver Gautschi

Kuo-Hsuan Hsu

Chih-Hsin Yang

Anna Minchom

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)

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.

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 875 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 other than NSCLC or thyroid cancer for participants who progressed on or intolerant to first line therapy (open)
* Cohort 2: Advanced RET fusion positive solid tumor other than NSCLC or thyroid cancer 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 other than NSCLC or thyroid cancer and RET-mutant MEN2 spectrum tumors (e.g. pheochromocytoma) 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 (closed)
* 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 (closed)

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

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)

Incidence rate and category of dose limiting toxicities (DLTs) during the first 28-day cycle of LOXO-292 (selpercatinib) treatment

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)

Phase 1: Number of Participants with a TRAE(s)

Phase 1: Number of Participants with an Abnormal Laboratory or Physical Exam Result(s)

Phase 1: ORR based on RECIST 1.1 or RANO, as Appropriate to Tumor Type

Phase 2: Best Change in Tumor Size from Baseline (by IRC and Investigator)

Phase 2: Time to Any and Best Response (by IRC and Investigator)

Phase 2: Percentage of Participants with any SAE(s)

Phase 1 and 2: PK: AUC of LOXO-292 (Selpercatinib)

Phase 1 and 2: PK: Cmax of LOXO-292 (Selpercatinib)

Eli Lilly and Company

Loxo Oncology, Inc.

Gelatin capsules supplied in 25-mg and 100-mg strengths administered orally daily

XL184

Gelatin capsules color and size-matched to XL184 capsules administered orally daily

Placebo

The purpose of this research study is to evaluate the progression-free survival (PFS) with XL184 as compared with placebo (an inactive substance) in subjects with unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC). Subjects will be randomized to receive XL184 or placebo in a 2:1 ratio. XL184 is an investigational drug that inhibits VEGFR2, MET and RET, kinases implicated in tumor formation, growth and migration.

The Clinical Steering Committee for this study, comprised of study doctors who specialize in medullary thyroid cancer, has provided guidance regarding the design of the study. The committee includes: Douglas Ball, MD, Barry Nelkin, PhD, Martin Schlumberger, MD and Steven Sherman, MD.

Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer

An International, Randomized, Double-Blinded, Phase 3 Efficacy Study of XL184 Versus Placebo in Subjects With Unresectable, Locally Advanced, or Metastatic Medullary Thyroid Cancer

The duration of Progression-Free Survival (PFS) using progression events as determined by Independent Review Committee (IRC) per mRECIST, or death due to any cause. The analysis was conducted after at least 315 subjects were randomized and at least 138 events were observed.

Duration of Overall Survival (OS) from the time of randomization to death due to any cause. A Kaplan-Meier analysis was performed to estimate the median.

The proportion of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) as determined by the Independent Review Committee (IRC.) Per Response Evaluation Criteria in Solid Tumor Criteria (mRECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) ≥ 20% increase in the sum of the longest diameter of target lesions. Overall Response Rate: ORR=CR +PR

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study To Assess ZD6474 (ZACTIMA™) Monotherapy In Locally Advanced or Metastatic Hereditary Medullary Thyroid Cancer	NCT00358956	Thyroid Cancer	ZD6474 (vandeta...	18 Years -	Sanofi
A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001)	NCT03157128	Non-Small Cell ... Medullary Thyro... Colon Cancer Any Solid Tumor	LOXO-292	12 Years -	Eli Lilly and Company
Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer	NCT00704730	Thyroid Cancer	XL184 Placebo	18 Years -	Exelixis
Adaptive Tyrosine Kinase Inhibitor (TKI) Therapy In Patients With Thyroid Cancer	NCT03630120	Thyroid Cancer Thyroid Cancer,... Differentiated ... Papillary Thyro... Follicular Thyr... Poorly Differen...	Lenvatinib Sorafenib Cabozantinib Vandetanib	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors	NCT03899792	Medullary Thyro... Infantile Myofi... Infantile Fibro... Papillary Thyro... Soft Tissue Sar...	LOXO-292	6 Months - 21 Years	Eli Lilly and Company
A Study of Selpercatinib (LY3527723) in Participants With Advanced Solid Tumors Including RET Fusion-positive Solid Tumors, Medullary Thyroid Cancer and Other Tumors With RET Activation	NCT04280081	Solid Tumor Medullary Thyro...	Selpercatinib	18 Years -	Eli Lilly and Company
A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors	NCT03899792	Medullary Thyro... Infantile Myofi... Infantile Fibro... Papillary Thyro... Soft Tissue Sar...	LOXO-292	6 Months - 21 Years	Eli Lilly and Company
Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer	NCT00704730	Thyroid Cancer	XL184 Placebo	18 Years -	Exelixis
An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer	NCT00410761	Thyroid Cancer	ZD6474 (Vandeta...	18 Years -	Sanofi

Spots Global Cancer Trial Database for mtc

Every month we try and update this database with for mtc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mtc

Every month we try and update this database with for mtc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mtc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.