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Adrenocortical CarcinomaPhase 2SIRACNCT00453895

Sunitinib in Refractory Adrenocortical Carcinoma

A Phase 2 study testing Sunitinib in people with Adrenocortical Carcinoma, run by University of Wuerzburg at 2 sites in Germany.

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

Although a first randomized trial in patients with advanced ACC leading to the establishment of a first line cytotoxic chemotherapy is ongoing (FIRM-ACT), the failure rate even of this FIRM-ACT study is most likely clearly above 50%. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adrenocortical Carcinoma
What is being tested?
Sunitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
2 sitesGermany
Study dates
Jul 2007to Feb 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histologically confirmed diagnosis of ACC
  • Locally advanced or metastatic disease not amenable to radical surgery resection
  • Radiologically monitorable disease
  • Progressing disease after one to three cytotoxic chemotherapy regimes including a platin-based protocol
  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
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  • Age ≥ 18 years
  • Adequate bone marrow reserve (neutrophils ≥ 1500/mm³ and platelets ≥100.000/mm³) and haemoglobin ≥ 9 g/dl
  • Negative pregnancy test and effective contraception in pre-menopausal female and male patients
  • Patient´s written informed consent
  • Ability to comply with the protocol procedures
  • If patients have been participated in another clinical trial evaluating treatment options for ACC (e.g. FIRM-ACT), the patient can only be included in the SIRAC trial, if:
  • the patient has discontinued study treatment of the previous trial according to the protocol
  • or the study chair of the previous trial gives written approval for inclusion of this individual patient in the SIRAC trial.

Who cannot join

  • History of prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other treated malignancies with no evidence of disease for at least three years.
  • Severe renal (serum creatinine > 2.5 x ULN) or hepatic insufficiency (ALT / AST > 2.5 x ULN or ALT/AST >5 x ULN if liver function abnormalities are due to the underlying malignancy and/or total serum bilirubin > 2.0 x ULN) and/or serum albumin < 3g/dl
  • Any of the following within the 8 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, or other severe thromboembolic event.
  • Ongoing cardiac dysrhythmias of NCI CTCAE grade 2, acute atrial fibrillation of any grade, or prolongation of the QTc interval to >470 msec for females
  • Left ventricular ejection fraction (LVEF) <45% as measured by echocardiogram
  • NCI CTCAE Grade 3 hemorrhage within 4 weeks of starting study treatment
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  • Hypertension that cannot be controlled by medications (>160/100 mmHg despite optimal medical therapy)
  • Pregnancy or breast feeding
  • Previous treatment with Sunitinib or any other VEGF- or PDGF-pathway directed agent.
  • Current treatment with strong CYP3A4 inhibitors or -inducers
  • Current treatment with another investigational drug
  • Current treatment with another anti-cancer drug
  • Patients with ileus within the last 28 days
  • Major surgery, radiation therapy, or systemic therapy within 3 weeks of first study treatment. At least 7 days should elapse from the time of minor surgical procedure including placement of an access device or fine needle aspiration before start of study treatment
  • Serious wounds that have not completely healed, active ulcer(s), or significant bone fracture(s).
  • Prior radiation therapy to >25% of the bone marrow.
  • Cachectic patients with a body mass index < 18 kg/m2
  • Any other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Charite Berlin

    Berlin

  • Dept. of Medicine I, University of Wuerzburg

    Würzburg, 97080

Other trials in Germany

About this study

Official title: Sunitinib in Refractory Adrenocortical-Carcinoma Patients Progressing After Cytotoxic Chemotherapy

Although a first randomized trial in patients with advanced ACC leading to the establishment of a first line cytotoxic chemotherapy is ongoing (FIRM-ACT), the failure rate even of this FIRM-ACT study is most likely clearly above 50%. Therefore, the majority of participating patients urgently need a new treatment option. However, up to date there is no evidence for a single regimen that might be promising in these treatment-refractory patients with ACC.

Sunitinib is an oral multitargeted tyrosine kinase inhibitor with anti-tumor and antiangiogenic activities, which is successfully tested in the treatment of patients with metastatic renal cell carcinoma, gastrointestinal stromal and neuroendocrine tumors after failure of standard cytotoxic chemotherapy.

The primary objective of this trial is to estimate the response (defined as progression-free survival of ≥ 12 weeks) rate associated with Sunitinib treatment in patients advanced ACC progressing after cytotoxic chemotherapy.

Being tested
Sunitinib
Keywords
Adrenal cancer refractory to cytotoxic therapy, Sunitinib, Multitargeted tyrosine-kinase inhibitor
Medical subject headings
Adrenocortical Carcinoma

What participants receive

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

Study groups in NCT00453895
Study groupRoleWhat they receive
SunitinibExperimentalSunitinib will be administered 50 mg per day for 4 weeks followed by 2 weeks off. treatment will continue until progressive disease or unacceptable toxicity
Receives: Drug: Sunitinib

What is being measured

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

  1. Assessment of Clinical Benefit Due to Treatment With Sunitinib

    Clinical benefit was defined as stable disease or better for at least 12 weeks

    Measured: 12 weeks

Secondary outcomes (4)

  1. Assessment of Objective Response Rates

    Objective Response Rate defined by RECIST 1.0

    Measured: 12 weeks

  2. Assessment of Progression-free Survival

    Progression-free survival is defined as time of start of study until documentation of Progress. 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

    Measured: up to 400 days

  3. Assessment of Overall Survival

    Overall Survival was defined as time from start of treatment until death or last follow-up.

    Measured: up to 36 months

  4. Assessment of Toxicity

    Adverse events were rated using the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (see http://ctep.cancer.gov/reporting/ctc.html).

    Measured: up to 400 days

Timeline

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

  1. First posted29 Mar 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionAug 2011
  4. Study completionFeb 2012

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00453895
Sponsor's protocol ID
SIRAC-1
Acronym
SIRAC
Status last verified
Aug 2018
First submitted
28 Mar 2007
Last updated
31 Jan 2019
Data monitoring committee
No

Publications

  • Kroiss M, Quinkler M, Johanssen S, van Erp NP, Lankheet N, Pollinger A, Laubner K, Strasburger CJ, Hahner S, Muller HH, Allolio B, Fassnacht M. Sunitinib in refractory adrenocortical carcinoma: a phase II, single-arm, open-label trial. J Clin Endocrinol Metab. 2012 Oct;97(10):3495-503. doi: 10.1210/jc.2012-1419. Epub 2012 Jul 26.

    PubMed 22837187

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sunitinib in people with Adrenocortical Carcinoma, run by University of Wuerzburg at 2 sites in Germany.

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 14 inclusion and 18 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 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. 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?

Yes. Results are posted in the registry (first posted 31 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Assessment of Clinical Benefit Due to Treatment With Sunitinib (time frame: 12 weeks). 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 NCT00453895, which also lists 1 linked publication.

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 31 Jan 2019.

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