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

Adenocarcinoma, Follicular

Thyroid Cancer, Follicular

vandetanib (ZD6474) 300 mg per os once daily

Vandetanib

Placebo

Clinical Sciences & Operations

This was a parallel group, randomized, double blind, placebo controlled, multicentre study designed to assess whether vandetanib (ZD6474) conferred an improvement in PFS as compared to placebo in participants with locally advanced or metastatic papillary or follicular thyroid carcinoma failing or unsuitable for radioiodine therapy. The trial was of a sufficient size so that if vandetanib (ZD6474) was truly active there was a high probability that it would demonstrate an effect sufficiently promising to warrant a follow-up assessment.

* Participants were seen weekly for the first 2 weeks, then again at Week 4, Week 8, and Week 12 after randomization, and every 12 weeks thereafter. Upon disease progression, all participants (both active and placebo) were unblinded and given the option to discontinue blinded study treatment and enter follow up and survival, or begin open label vandetanib (ZD6474) 300 mg treatment. All participants were followed to collect survival data until greater than or equal to (\>=) 50% of participants had died. Participants who were taking vandetanib (ZD6474) at the time of study closure and wished to remain on therapy were allowed to continue for as long as the Investigator felt that they were obtaining clinical benefit, or until they were given another anti-cancer therapy. The safety data from all participants was assessed on an ongoing basis, including discontinuation and follow up.
* Radiologic evaluation using RECIST criteria was performed every 12 weeks (+/- 2 weeks). All medical images were centralized assessed at the site and centrally reviewed. Participants were evaluated until progression, and then followed up for survival, regardless of whether they continued randomized treatment, unless they withdrew consent. Post progression open-label vandetanib (ZD6474) were offered at the investigators discretion.
* All participants submitted a suitable archived tumor sample prior to randomization. In the event that a suitable archived sample was not available within 2 weeks prior to randomization, a fresh tumor sample was obtained in its place prior to randomization. If a participant underwent the fresh tumor biopsy procedure, this specimen would satisfy the first optional tumor biopsy submission should they consented to the exploratory part of the study.

Efficacy and Safety of Vandetanib (ZD6474) in Patients With Metastatic Papillary or Follicular Thyroid Cancer

A Randomized, Double Blind, Placebo-controlled Phase II, Multi-Centre Study to Assess the Efficacy and Safety of Vandetanib (ZD6474) in Patients With Locally Advanced or Metastatic Papillary or Follicular Thyroid Carcinoma Failing or Unsuitable for Radioiodine Therapy

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

number of participants that achieved disease control 6 months after randomization. Best objective response of complete response + partial response + stable disease \> 24 weeks according to RECIST criteria

Best objective response of the participants from an average of 46.7 months, defined as complete or partial response according to RECIST criteria

Interim analysis time to date of randomization to date of death (data not mature at the time of this analysis, so number of deaths displayed instead.

Genzyme, a Sanofi Company

Analysis was performed for the safety population. For participants who continued Vandetanib after the LPLV because they still benefited from it per the investigator's judgment, SAEs were collected as long as they received treatment. No non-serious adverse events were collected after LPLV for the open-label period of the study.

Participants received vandetanib (ZD6474) 300 mg orally once daily, until disease progression or until 12 months of stable disease during randomized treatment period, or until the end of the trial whichever comes first.

Randomized Treatment Period: Vandetanib (ZD6474)

Participants received placebo matching to vandetanib (ZD6474) tablet orally once daily, until disease progression or until 12 months of stable disease during randomized treatment period, or until the end of the trial whichever occurred first.

Randomized Treatment Period: Placebo

Participants still receiving vandetanib (ZD6474) treatment at the end of the trial were offered the opportunity to enter the open label phase and continue to receive vandetanib (ZD6474) treatment as long as they still benefitted of it per investigator judgment or until subsequent anti-cancer therapy.

Open-Label Treatment Period: Vandetanib/Vandetinib (ZD6474)

Participants who experienced disease progression during the randomized phase were offered to enter the open-label phase and receive vandetanib (ZD6474) if, as long as they benefitted of it or until subsequent anti-cancer therapy.

Open-Label Treatment Period: Placebo/Vandetinib (ZD6474)

ZD6474

PLACEBO

Total

Age, Continuous

Analysis was performed on intent to treat (ITT) population which included all randomized participants who received at least one dose of study treatment.

Trial Transparency Team

Time to Tumor Progression

Disease Control Rate at 6 Months

Objective Response Rate

For the efficacy part, 72 were randomized to received ZD6474 and 73 placebo. For the safety part, 73 patients received at least one dose of ZD6474 and 72 placebo

Time to Death

Participants received vandetanib (ZD6474) 300 mg orally once daily, until disease progression or until 12 months of stable disease during randomized treatment period, or until the end of the trial whichever comes first. Participants still receiving vandetanib (ZD6474) treatment at the end of the trial were offered the opportunity to enter the open label phase and continue to receive vandetanib (ZD6474) treatment as long as they still benefitted of it per investigator judgment or until subsequent anti-cancer therapy.

ZD6474/ ZD6474

Participants received placebo matching to vandetanib (ZD6474) tablet orally once daily, until disease progression or until 12 months of stable disease during randomized treatment period, or until the end of the trial whichever occurred first. Participants who experienced disease progression during the randomized phase were offered to enter the open-label phase and receive vandetanib (ZD6474) if, as long as they benefitted of it or until subsequent anti-cancer therapy.

PLACEBO/ ZD6474

Randomized Treatment Period (433 Days)

Open-label Period (590 Days)

Symptoms and General Pathology

Blood and Lymph Conditions

Immune System Diseases

Recurrence

Thyroid Cancer, Papillary

Leukemia-Lymphoma, Adult T-Cell

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma, Papillary

Papillary Thyroid Carcinoma

Adult T-cell Leukemia/lymphoma

Micronutrients

Anti-Infective Agents

Bortezomib

Iodine

Cadexomer iodine

Bortezomib 1.3 mg/m\^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.

Administered IV at the dose of 1.3 mg/m\^2 on a twice-weekly schedule for 2 consecutive weeks on days 1, 4, 8, and 11, followed by a 10 day rest period on days 12-21 (one cycle). In the absence of clinical progression, treatment continued for a minimum of 4 treatment cycles (or 12 weeks).

Steven Sherman

This phase II trial is studying how well bortezomib works in treating patients with metastatic thyroid cancer that did not respond to radioactive iodine therapy. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

PRIMARY OBJECTIVE:

I. Determine the efficacy of bortezomib, in terms of tumor response rate, in patients with metastatic papillary or follicular thyroid cancer unresponsive to prior radioiodine therapy.

SECONDARY OBJECTIVE:

I. Determine the clinical activity of this drug, in terms of progression-free survival, in patients treated with this drug.

OUTLINE: This is an open-label, multicenter study. Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically.

Bortezomib in Treating Patients With Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy

A Phase II Study of Bortezomib in Metastatic Papillary Thyroid Carcinoma or Follicular Thyroid Carcinoma

Response Rate calculated as number of participants with Complete or Partial Response divided by total participants. Baseline scan and confirmatory scans obtained 6 weeks following initial documentation of objective response using Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>30% decrease in sum longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Baseline scan and confirmatory scans obtained 6 weeks following initial documentation of objective response using Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>30% decrease in sum longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Progression is defined using 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

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
Efficacy and Safety of Vandetanib (ZD6474) in Patients With Metastatic Papillary or Follicular Thyroid Cancer	NCT00537095	Thyroid Neoplas...	Vandetanib Placebo	18 Years -	Sanofi
Bortezomib in Treating Patients With Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy	NCT00104871	Insular Thyroid... Recurrent Thyro... Stage II Follic... Stage II Papill... Stage IV Follic... Stage IV Papill...	Bortezomib	18 Years -	National Cancer Institute (NCI)
Study Of AG-013736 In Patients With 131I-Refractory Thyroid Cancer	NCT00389441	Thyroid Neoplas...	AG-013736	18 Years -	Pfizer
Phase II Study of Afinitor vs. Sutent in Patients With Metastatic Non-Clear Cell Renal Cell Carcinoma	NCT01108445	Advanced Non-cl...	Everolimus Sunitinib	18 Years -	Duke University
Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer	NCT00984282	Thyroid Neoplas...	Sorafenib (Nexa... Placebo	18 Years -	Bayer
Bortezomib in Treating Patients With Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy	NCT00104871	Insular Thyroid... Recurrent Thyro... Stage II Follic... Stage II Papill... Stage IV Follic... Stage IV Papill...	Bortezomib	18 Years -	National Cancer Institute (NCI)
Efficacy and Safety of Vandetanib (ZD6474) in Patients With Metastatic Papillary or Follicular Thyroid Cancer	NCT00537095	Thyroid Neoplas...	Vandetanib Placebo	18 Years -	Sanofi
REVLIMID® (Lenalidomide) for Therapy of Radioiodine-Unresponsive Papillary and Follicular Thyroid Carcinomas	NCT00287287	Thyroid Neoplas...	Lenalidomide	18 Years -	University of Kentucky
Extent of Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma	NCT01149161	Carcinoma	Routine central...	18 Years - 80 Years	Samsung Medical Center
EPO906 Therapy in Patients With Advanced Kidney Cancer	NCT00035243	Kidney Neoplasm...	epothilone b	18 Years - 85 Years	Novartis
REVLIMID® (Lenalidomide) for Therapy of Radioiodine-Unresponsive Papillary and Follicular Thyroid Carcinomas	NCT00287287	Thyroid Neoplas...	Lenalidomide	18 Years -	University of Kentucky
EPO906 Therapy in Patients With Advanced Kidney Cancer	NCT00035243	Kidney Neoplasm...	epothilone b	18 Years - 85 Years	Novartis

Spots Global Cancer Trial Database for papillary

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

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