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Thyroid CancerPhase 2NCT00176748

Treatment for Patients With Metastatic Thyroid Cancer

A Phase 2 study testing AG 6013736 in people with Thyroid Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is being done to find out the good and bad effects of an investigational drug that is not approved for sale, called AG-013736. Tumors need blood vessels in order to continue to grow, and AG-013736 is thought to work by playing a role in preventing new blood vessels from growing. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Cancer
What is being tested?
AG 6013736
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
Jul 2005to Jun 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To be eligible for the study, subjects must satisfy all the following criteria:
  • Histologically documented thyroid cancer with metastases.
  • Failure of 131I to control the disease or 131I is not an appropriate therapy (eg, due to lack of iodine uptake by the tumor).
  • No expectation of further effects of prior anticancer therapy.
  • At least 1 target lesion, as defined by RECIST (Appendix C), that has not been irradiated. New lesions that have developed in a previously irradiated field may be used as sites of measurable disease assuming all other criteria are met. All target lesions must have a unidimensional diameter of at least 2 cm. (1 cm is acceptable for spiral CT scans if the reconstruction algorithm is 0.5 cm). Baseline measurements/evaluations must be completed within 4 weeks prior to treatment.
  • Adequate bone marrow, hepatic, and renal function documented within 14 days prior to treatment as documented by:
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  • Absolute neutrophil count (ANC, calculated as the absolute number of neutrophils and bands) ≥1.5 x 109 cells/L
  • Platelets ≥100 x 109 cells /L
  • AST and ALT ≤2.5 x upper limit of normal (ULN), unless there are liver metastases in which case AST and ALT ≤5.0 x ULN
  • Total bilirubin ≤1.5 x ULN
  • Serum creatinine ≤1.5 x ULN or calculated creatinine clearance ≥60 mL/min
  • Urinary protein <2+ by urine dipstick. If dipstick is ≥2+ then a 24-hour urine collection can be done and the patient may enter only if urinary protein is <2 g per 24 hours
  • Age ≥18 years.
  • ECOG performance status of 0 or 1 (see Appendix D)
  • No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be ≤140, and the baseline diastolic blood pressure readings must be ≤90. Patients whose hypertension is controlled by antihypertensive therapies are eligible.
  • Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to treatment.
  • Written and voluntary informed consent.

Who cannot join

  • Subjects with one or more of the following criteria are ineligible for this study:
  • Central lung lesions involving major blood vessels (arteries or veins). (Central lesions that maintain the structural integrity of vessels have the potential to bleed if the tumor lesion undergoes necrosis. MRI or CT angiography should be used in any case where there is any question as to whether blood vessels are involved.)
  • History of hemoptysis
  • Gastrointestinal abnormalities including:
  • inability to take oral medication
  • requirement for intravenous alimentation
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  • prior surgical procedures affecting absorption including gastric resection
  • treatment for active peptic ulcer disease in the past 6 months
  • active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy.
  • malabsorption syndromes.
  • Previous treatment with anti-angiogenesis agents including thalidomide, or inhibitors of epidermoid growth factor (EGF), platelet derived growth factor (PDGF), or fibroblast growth factors (FGF) receptors.
  • Current use or anticipated inability to avoid use of drugs that are known potent CYP3A4 inhibitors (ie, grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, clarithromycin, ergot derivatives, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, and delavirdine).
  • Current use or anticipated inability to avoid use of drugs that are known CYP3A4 or CYP1A2 inducers (ie, carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, primidone, rifabutin, rifampin, and St. John's wort).
  • Active seizure disorder or evidence of brain metastases.
  • A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment.
  • History of a malignancy (other than thyroid cancer) except those treated with curative intent for skin cancer (other than melanoma) or in situ breast or cervical cancer or those treated with curative intent for any other cancer with no evidence of disease for 5 years
  • Major surgical procedure or any radiation therapy within 4 weeks of treatment.
  • Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
  • Patients (male and female) having procreative potential who are not using adequate contraception or practicing abstinence
  • Women who are pregnant or breast-feeding.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Michigan Cancer Center

    Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: Phase 2 Study of the Anti-Angiogenesis Agent AG-013736 in Patients With Metastatic Thyroid Cancer Who Are Refractory to or Not Suitable Candidates for 131I Treatment

This study is being done to find out the good and bad effects of an investigational drug that is not approved for sale, called AG-013736. Tumors need blood vessels in order to continue to grow, and AG-013736 is thought to work by playing a role in preventing new blood vessels from growing. We want to see if AG-013736 has any effect on your disease by making your tumor smaller and if so, for how long. We also want to test the safety [the effect on your body] of AG-013736 and to measure the amount of AG-013736 that gets into your blood. AG-013736 has been given to over 140 patients with cancer on other studies.

Read the detailed description

The American Cancer Society estimates that there will be about 23,600 new cases of thyroid cancer (5,960 in men and 17,640 in women) annually in the United States, and about 1,460 people (620 men and 840 women) will die from this disease.1 It is the most common malignancy of the endocrine system. Depending upon type and stage, thyroid cancer may be treated with surgery, radioactive iodine (131I), hormone treatment, external radiation, or chemotherapy.

The systemic therapy of metastatic disease remains palliative until new agents are found that might afford a better prognosis. Thyroid tumors are often vascular, and a decrease in the number of blood vessels that supply the tumor may starve it of needed nutrients. An approach to blocking the growth of blood vessels that supply the tumor is to inhibit the VEGF receptor tyrosine kinase (VEGFR TK) signaling pathway. The VEGFR TK inhibitor SU011248 has produced 4 objective responses in 15 patients receiving the drug on Phase 1 studies.2 AG-013736 is another VEGFR TK inhibitor. Besides having potential anti-angiogenesis properties through VEGFR TK inhibition, it also has additional potential antitumor through platelet derived growth factor receptor (PDGFR) TK inhibition.

Conditions
Thyroid Cancer
Being tested
AG 6013736
Medical subject headings
Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AG 6013736Drug

    5 mg po bid

Study groups in NCT00176748
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: AG 6013736

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary objective of this study is to determine the response rate of AG-013736 in patients with metastatic thyroid cancer (who are refractory to or not suitable candidates for 131I treatment).

    Measured: Approximately 2 years

Secondary outcomes (5)

  1. To determine the safety profile of AG-013736

    Measured: Approximately 2 years

  2. To determine the progression-free survival

    Measured: This is a variable in the outcome measure (time frame cannot be determined).

  3. To determine the duration of response.

    Measured: The time frame cannot be determined as it is the variable that is being studied for this Outcome Measure.

  4. To determine overall survival.

    Measured: Time Frame cannot be approximated as this is the variable that is being studied in this Outcome Measure.

  5. To obtain blood samples for population pharmacokinetic analyses in order to explore relationships between clinical response and plasma soluble proteins.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2005 (estimated)
  2. Study startJul 2005
  3. Primary completionAug 2006
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00176748
Sponsor's protocol ID
UMCC 2005-036
Other IDs
HUM 216
Status last verified
Jan 2010
First submitted
9 Sep 2005
Last updated
15 Jan 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AG 6013736 in people with Thyroid Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary objective of this study is to determine the response rate of AG-013736 in patients with metastatic thyroid cancer (who are refractory to or not suitable candidates for 131I treatment). (time frame: Approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00176748.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2010.

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