Gland and Hormone Related Diseases

All Conditions

Neoplasms

Thyroid Diseases

Carcinoma

Thyroid Neoplasms

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

Spots Global Cancer Trial Database for Study Of AG-013736 In Patients With 131I-Refractory Thyroid Cancer

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