Neoplasms

All Conditions

Gland and Hormone Related Diseases

Carcinoma

Thyroid Neoplasms

Thyroid Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Axitinib

Angiogenesis Inhibitors

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

AG-013736, tablets 5 mg BID , treatment will continue until tumor progression or toxicity

AG-013736

Pfizer CT.gov Call Center

The primary purpose is to determine how effective AG-013736 is in shrinking thyroid cancer that is resistant to radioactive iodine

Additional study details: assess safety and efficacy

Study Of AG-013736 In Patients With 131I-Refractory Thyroid Cancer

A Pivotal Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Patients With 131I-Refractory Metastatic Or Unresectable Locally-Advanced Thyroid Cancer

Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST). CR: disappearance of all target/non-target lesions and no appearance of new lesions. PR: at least (\>=)30 percent(%) decrease in sum of the longest dimensions (LDs) of the target lesions (taking as a reference the baseline sum), without progression of non-target lesions and no appearance of new lesions. Confirmed responses: those persist on repeat imaging study \>=4 weeks after initial documentation of response.

PFS: Time in weeks from the start of study treatment to first documentation of objective disease progression or to death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of first dose of study treatment plus 1) divided by 7. Progression is defined using RECIST, as \>=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD since start of study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.

Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.

Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).

Symptom severity score is comprised of average of 13 MDASI core items (pain, fatigue, nausea, disturbed sleep, distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sadness, vomiting, numbness or tingling). Participants were asked to rate severity of each symptom at their worst in last 24 hours; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Total average score range: 0 to 10. Lower scores indicated better outcome.

Symptom interference score is comprised of average of 6 function items from MDASI core (general activity, mood, work, relations with others, walking, and enjoyment of life). Participants were asked to rate how much symptoms have interfered in last 24 hours; each item rated from 0 to 10, with 0 = did not interfere and 10 = interfered completely. Total average score range: 0 to 10. Lower scores indicated better outcome.

Pfizer

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.

Age Continuous

Sex: Female, Male

Pfizer ClinicalTrials.gov Call Center

Intent-to-Treat (ITT) population included all participants who were enrolled in the study and received at least 1 dose of study treatment.

Percentage of Participants With Objective Response (OR)

ITT population included all participants who were enrolled in the study and received at least 1 dose of study treatment.

Progression Free Survival (PFS)

Subgroup of participants from the ITT population, with a confirmed objective tumor response (CR or PR).

Duration of Response (DR)

Overall Survival (OS)

Baseline (n= 49)

Change at C1D15 (n= 40)

Change at C2D1 (n= 42)

Change at C2D15 (n= 37)

Change at C3D1 (n= 43)

Change at C4D1 (n= 39)

Change at C5D1 (n= 36)

Change at C6D1 (n= 36)

Change at C7D1 (n= 29)

Change at C8D1 (n= 28)

Change at C9D1 (n= 27)

Change at C10D1 (n= 25)

Change at C11D1 (n= 25)

Change at C12D1 (n= 24)

Change at C13D1 (n= 24)

Change at C14D1 (n= 24)

Change at C15D1 (n= 24)

Change at C16D1 (n= 23)

Change at C17D1 (n= 20)

Change at C18D1 (n= 20)

Change at C19D1 (n= 18)

Change at C20D1 (n= 16)

Change at C21D1 (n= 16)

Change at C22D1 (n= 15)

Change at C23D1 (n= 14)

Change at C24D1 (n= 11)

Change at C25D1 (n= 11)

Change at C26D1 (n= 9)

Change at C27D1 (n= 9)

Change at C28D1 (n= 10)

Change at C29D1 (n= 10)

Change at C30D1 (n= 10)

Change at C31D1 (n= 9)

Change at C32D1 (n= 9)

Change at C33D1 (n= 9)

Change at C34D1 (n= 8)

Change at C35D1 (n= 6)

Change at C36D1 (n= 6)

Change at C37D1 (n= 5)

Change at C38D1 (n= 5)

Change at C39D1 (n= 5)

Change at C40D1 (n= 5)

Change at C41D1 (n= 5)

Change at C42D1 (n= 5)

Change at C43D1 (n= 5)

Change at C44D1 (n= 5)

Change at C45D1 (n= 4)

Change at C46D1 (n= 4)

Change at C47D1 (n= 4)

Change at C48D1 (n= 3)

Change at C49D1 (n= 3)

Change at C50D1 (n= 3)

Change at C51D1 (n= 3)

Change at C52D1 (n= 1)

Change at C53D1 (n= 1)

Change at C54D1 (n= 1)

Change at C55D1 (n= 1)

Change at C56D1 (n= 1)

Change at C57D1 (n= 1)

Change at C58D1 (n= 1)

Change at C59D1 (n= 1)

Change at C60D1 (n= 1)

Change at C61D1 (n= 1)

Change at C62D1 (n= 1)

Change at follow-up (n= 12)

ITT population included all participants who were enrolled in the study and received at least 1 dose of study treatment. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants evaluable at each time point.

Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score

Baseline (n= 48)

Change at C2D1 (n= 41)

Change at C2D15 (n= 36)

Change at C3D1 (n= 42)

Change at C4D1 (n= 37)

Change at C12D1 (n= 23)

Change at C20D1 (n= 15)

Change at C21D1 (n= 15)

Change at C22D1 (n= 14)

Change at C28D1 (n= 28)

Change at C29D1 (n= 29)

Change at C30D1 (n= 30)

Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score

Overall Study

Rare Diseases

Thyroid Carcinoma, Anaplastic

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Anaplastic Thyroid Cancer

Thyroid Cancer, Medullary

Sorafenib

sorafenib

Marcia S Brose, MD PhD

The goal of this study is to determine the activity of sorafenib in patients with advanced (metastatic or recurrent) thyroid cancer.

Phase II Trial of Sorafenib (Nexavar) in Patients With Advanced Thyroid Cancer

Phase II Study of BAY 43-9006 in Patients With Metastatic Thyroid Cancer

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

This is the result of the Kaplan Meier analysis of all patients treated with sorafenib

University of Pennsylvania

Associate Professor

This is a single arm study.

sorafenib: 400mg PO BID daily

Age, Continuous

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

DIfferentiated

Poorly Differentiated

Medullary

Anaplastic

Histology subtype

ECOG Performance Status 0

ECOG Performance Status 1

Eastern Cooperative Oncology Group (ECOG) performance status is a well known classification system for patient performance status. The scale goes from 0 to 4. With 0 being fully active and functional and a 4 being 100% bedridden.

ECOG Performance Status at Baseline

Four patients were deemed ineligible as a result of inadequate CBC and the establishment of an alternative diagnosis resulting from secondary pathology review.

Dr. Marcia Brose

Differentiated

Poorly Differenitated

Responses were calculated by total enrolled to each group by histologic subtype.

To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma.

Progression Free Survival For Entire Study (55 Total Patients)

Of the 59 patients that were consented, four patients were deemed ineligible as a result of inadequate CBC and the establishment of an alternative diagnosis resulting from secondary pathology review. Therefore the total number of patients analyzed going forward was 55.

Median Progression Free Survival in Patients Receiving BAY 43-9006 (Sorafenib).

Micronutrients

Anti-Infective Agents

Panobinostat

Iodine

Cadexomer iodine

Histone Deacetylase Inhibitors

LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.

LBH589

Anne Traynor, M.D.

The purpose of this study is to evaluate the tumor response rate in patients with metastatic medullary thyroid cancer (MTC) or radioiodine resistant differentiated thyroid cancer (DTC) after receiving treatment with LBH589 20 mg by mouth, three times weekly. Time to progression, overall survival, toxicity, tolerability, and Notch1 protein expression patterns will also be evaluated.

Medullary thyroid cancer (MTC) is a neuroendocrine tumor and accounts for 3-5% of cases of thyroid cancer. The majority of patients with MTC do not present with early stage disease. Differentiated thyroid cancer (DTC) accounts for \>90% of all thyroid cancers. In a sub-set of patients, thyroid cells become resistant to I-131 radioiodine therapy and subsequently develop distant metastases. In both MTC and DTC, systemic chemotherapy for metastatic disease is largely ineffective.

LBH589 is a histone deacetylase (HDAC) with recently demonstrated activity to inhibit the Notch1 signaling pathway in MTC cancer cells and suppress tumor cell proliferation in DTC cancer cells. This clinical trial will evaluate the tumor response rate of LBH589 in patients with metastatic MTC or radioactive iodine resistant DTC.

Trial of LBH589 in Metastatic Thyroid Cancer

A Phase II Trial of LBH589 in Patients With Metastatic Medullary Thyroid Cancer and Radioactive Iodine Resistant Differentiated Thyroid Cancer

per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v.1.0) for target lesions and assessed by CT/MRI: "Response" includes Complete Response (CR, disappearance of all target lesions), or Partial Response (PR, \>=30% decrease in the sum of the longest diameter of target lesions). "No Response" includes Stable Disease (SD, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease), and Progressive Disease (PD, at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).)

Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Time to progression is defined as the number of days from the day of first LBH589 administration to the day the patient experienced an event of disease progression or death, whichever came first. Progression was assessed every 3 months until death or up to 5 years, whichever occurred first.

For a given patient, overall survival (OS) is defined as the number of days from the day of first LBH589 administration until the patient's death. If a patient was alive at the time of analysis, then the patient's data is censored at the date of the last available evaluation.Survival was assessed every three months until death or final data analysis, whichever occurred first.

Change in serum Thyroglobulin level from baseline to end of treatment. Treatment continued until either extraordinary medical circumstances, disease progression, toxicity, subject withdrawal, or death. At the time subjects came off of study treatment for one of the reasons already listed, a sample was collected for tumor markers.

Most frequent toxicities at least possibly related to panobinostat, grades 2-4 (grading based on NCI common terminology criteria for adverse events CTCAE version 3). Toxicities were collected from the time the patient provided informed consent until 4 weeks after the patient stopped LBH589.

Tolerability and toxicity were not assessed separately, therefore tolerability is reported as toxicity.

Novartis Pharmaceuticals

University of Wisconsin, Madison

LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.

30-39 years

40-49 years

50-59 years

60-69 years

70-79 years

Age, Customized

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Abigail Mapes, Thoracic Oncology Research Program Manager

No response

Response

Tumor Response Rate to LBH589.

Notch1 protein expression was not measured due to lack of efficiency of study intervention

Protein Expression Patterns of Notch1 in Thyroid Tissue Samples.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study Of AG-013736 In Patients With 131I-Refractory Thyroid Cancer	NCT00389441	Thyroid Neoplas...	AG-013736	18 Years -	Pfizer
Study Of AG-013736 In Patients With 131I-Refractory Thyroid Cancer	NCT00389441	Thyroid Neoplas...	AG-013736	18 Years -	Pfizer
Phase II Trial of Sorafenib (Nexavar) in Patients With Advanced Thyroid Cancer	NCT00654238	Metastatic Diff... Metastatic Poor... Metastatic Anap... Metastatic Medu...	sorafenib	18 Years -	University of Pennsylvania
Trial of LBH589 in Metastatic Thyroid Cancer	NCT01013597	Thyroid Carcino...	LBH589	18 Years -	University of Wisconsin, Madison
EPO906 Therapy in Patients With Advanced Kidney Cancer	NCT00035243	Kidney Neoplasm...	epothilone b	18 Years - 85 Years	Novartis
Phase II Trial of Sorafenib (Nexavar) in Patients With Advanced Thyroid Cancer	NCT00654238	Metastatic Diff... Metastatic Poor... Metastatic Anap... Metastatic Medu...	sorafenib	18 Years -	University of Pennsylvania
Phase II Trial of Sorafenib (Nexavar) in Patients With Advanced Thyroid Cancer	NCT00654238	Metastatic Diff... Metastatic Poor... Metastatic Anap... Metastatic Medu...	sorafenib	18 Years -	University of Pennsylvania
EPO906 Therapy in Patients With Advanced Kidney Cancer	NCT00035243	Kidney Neoplasm...	epothilone b	18 Years - 85 Years	Novartis

Spots Global Cancer Trial Database for medullary

Every month we try and update this database with for medullary 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 medullary

Every month we try and update this database with for medullary 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 medullary 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.