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Adrenocortical CarcinomaPhase 2NCT01514526

Clinical Trial of Dovitinib in First-line Metastatic or Locally Advanced Non-resectable Adrenocortical Carcinoma

A Phase 2 study testing Dovitinib in people with Adrenocortical Carcinoma, run by Spanish Oncology Genito-Urinary Group at 7 sites in Spain.

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

Design: non-randomized, open label, phase II clinical trial. Study population and disease: adult patients with metastatic or locally advanced non-resectable adrenocortical carcinoma, confirmed histologically. Estimated number of patients: 15. 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?
Dovitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
7 sitesSpain
Study dates
Jan 2012to Nov 2016
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

  • Male or female patients aged ≥ 18 years old
  • A performance status of 0, 1, or 2, according to the Eastern Cooperative Oncology Group (ECOG) scale.
  • Histologically confirmed adrenocortical carcinoma.
  • Metastatic or locally advanced non-resectable disease.
  • At least one radiologically measurable lesion, according to RECIST 1.1.
  • Adequate liver function as shown by: serum or plasma ALT and AST ≤ 3.0 x ULN (regardless of the presence or absence of metastases)and serum or plasma total bilirubin: ≤ 1.5 x ULN.
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  • Adequate bone marrow function as shown by: blood absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L and hemoglobin (Hb) > 9g/dL.
  • Adequate renal function as shown by serum creatinine ≤ 1.5 x ULN.
  • Patients give a written informed consent obtained according to local guidelines.

Who cannot join

  • Prior chemotherapy other than mitotane (Patients who have previously received mitotane will only be eligible if drig has been withdrawn at least two weeks earlier than dovitinib first dose is administered).
  • Patients with another primary malignancy within 3 years prior to starting the study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, or completely excised basal or squamous cell carcinoma of the skin.
  • Patients who have received radical radiotherapy ≤4 weeks prior to starting the study treatment or who have not recovered from radiotherapy-related toxicities. Palliative radiotherapy for bone lesions ≤2 weeks prior to starting study treatment is allowed.
  • Patients who have undergone any major surgery (i.e., intra-thoracic, intrabdominal, or intra-pelvic) ≤4 weeks prior to starting study treatment or who have not recovered from side effects of such therapy.
  • Patients with a history of pulmonary embolism (PE) within the past 6 months or untreated deep-venous-thrombosis (DVT) within the past 6 months. Adequately treated DVT will be permitted providing that patient has been on anticoagulation for at least 2 weeks.
  • Patients with impaired cardiac function or clinically significant cardiac diseases, including any of the following:
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  • History or presence of serious uncontrolled ventricular arrhythmias.
  • Clinically significant resting bradycardia.
  • LVEF <45% when assessed by 2-D echocardiogram (ECHO) or multiple gated acquisition scan (MUGA). (No basal cardiac test is mandatory other than ECG)
  • Any of the following within 6 months prior to starting study treatment: Myocardial infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF),Cerebrovascular Accident (CVA), Transient Ischemic Attack TIA).
  • Uncontrolled hypertension defined by a SBP ≥160 mm Hg and/or DBP ≥100 mm Hg, with or without anti-hypertensive medication. Initiation or adjustment of antihypertensive medication (s) is allowed prior to study entry.
  • Patients with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of Dovitinib (TKI258) (i.e., severe ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or extensive (>1m) small bowel resection, inability to swallow oral medications). Prior partial or total gastrectomy is not an exclusion criterion.
  • Known diagnosis of human immunodeficiency virus (HIV) infection. HIV testing is not mandatory.
  • Patients who are currently receiving full dose of anticoagulation treatment with therapeutic doses of dicumarinical drugs as warfarin/acenocoumarol or anti-platelet therapy (i.e.,clopidogrel bisulfate). Treatment with acetylsalicyclic acid 100mg daily is allowed, as well as prophylactic or therapeutic low-weight-heparin.
  • Pregnant or breast-feeding women.
  • Women of child-bearing potential not employing an effective method of birth control. Effective contraception (e.g. condom with spermicidal jelly, foam suppository or film; diaphragm with spermicide; male condom and diaphragm with spermicide) must be used throughout the trial and 8 weeks after the end of Dovitinib treatment. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. Women of child-bearing potential defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months), must have a negative serum pregnancy test ≤ 14 days prior to starting study drug. Women of child-bearing potential not employing and not willing to use an effective method of birth control. Post-menopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.
  • Fertile males not willing to use contraception as stated above.
  • Patients unwilling or unable to comply with the protocol.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Spain7 sites

  • Hospital Universitario Fundación de Alcorcón

    Alcorcón, Madrid, 28922

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

  • Hospital Universitario Central de Asturias

    Oviedo, 33006

  • Complejo Hospitalario de Navarra

    Pamplona, 31008

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, A Coruña, 15706

  • Fundación Instituto Valenciano de Oncología

    Valencia, 46009

Other trials in Spain

About this study

Official title: Phase II Clinical Trial of Dovitinib (TKI-258) in First-line Metastatic or Locally Advanced Non-resectable Adrenocortical Carcinoma

  • Design: non-randomized, open label, phase II clinical trial.
  • Study population and disease: adult patients with metastatic or locally advanced non-resectable adrenocortical carcinoma, confirmed histologically.
  • Estimated number of patients: 15.
  • Study drug: dovitinib (TKI-258), dosed on a flat scale of 500mg/day on a 5 days on / 2 days off.
  • Treatment duration: study treatment period will be continued until disease progression, unacceptable toxicity, death or premature withdrawal from study. An average of 6 months treatment period is expected.
  • Study duration: expected recruitment period will be 18 months, and patients will be followed for 6 additional months after last patient is included in the trial.Study total expected duration is 24 months.
  • Sites: the study is planned to be conducted in 7 Spanish centers.
Read the detailed description

Non applicable

Being tested
Dovitinib
Keywords
Adrenocortical carcinoma
Medical subject headings
Adrenocortical Carcinoma

What participants receive

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

  • DovitinibDrug

    Also called TKI258

    Dovitinib (TKI-258), gelatin capsule of 100mg, developed and supplied by Novartis Inc. The study regimen consists of the administration of 500 mg / day (5 x 100mg) once daily, taken orally with a large amount of water, preferably one hour prior to a meal or at least two hours following a meal. This dose will be taken once daily according to 5 days on/2 days off schedule.

    The patient will continue on treatment until disease progression,unacceptable toxicity, death or premature withdrawal.

Study groups in NCT01514526
Study groupRoleWhat they receive
DovitinibExperimentalDovitinib (TKI-258) f 500 mg / day (5 x 100mg) once daily. The patient will continue on treatment until disease progression,unacceptable toxicity, death or premature withdrawal.
Receives: Drug: Dovitinib

What is being measured

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

  1. Efficacy

    Efficacy in terms of overall response rate (ORR) of dovitinib as treatment for metastatic or locally advanced non-resectable primary adrenocortical carcinoma (measured by an external evaluator)

    Measured: Up to 6 months (Study treatment expected duration)

Secondary outcomes (6)

  1. Safety profile of dovitinib in study population

    Safety will be assessed considering the number of study participants with Adverse Events during the conduct of the trial, from date of patient inclusion until the date of study end, up to 24 months.

    Measured: Up to 24 months (Study expected duration, including patient treatment and follow up)

  2. Efficacy of dovitinib in reducing ACC hormonal production (cortisol, testosterone, aldosterone or estrogens)

    Efficacy of dovitinib in reducing ACC hormonal production (cortisol, testosterone, aldosterone or estrogens)

    Measured: Up to 6 months (Study treatment expected duration)

  3. Progression free survival (PFS) in all treated patients (measured by an external evaluator)

    From date of patient inclusion until the date of first documented progression, assessed up to 24 months.

    Measured: Up to 24 months (Study expected duration, including patient treatment and follow up)

  4. Overall survival (OS)(measured by an external evaluator)

    From date of patient inclusion until the date of of death from any cause, assessed up to 24 months.

    Measured: Up to 24 months (Study expected duration, including patient treatment and follow up)

  5. Quality of Life (QoL)

    From date of patient inclusion until the date of study end, up to 24 months.

    Measured: Up to 24 months (Study expected duration, including patient treatment and follow up)

  6. Progression Free Survival and Overall Survival (determined by the local researchers)

    From date of patient inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.

    Measured: Up to 24 months (Study expected duration, including patient treatment and follow up)

Timeline

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

  1. First posted23 Jan 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionJul 2013
  4. Study completionNov 2016

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
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01514526
Sponsor's protocol ID
SOGUG2011-03
Other IDs
2011-002873-47
Status last verified
Apr 2016
First submitted
21 Dec 2011
Last updated
25 Apr 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dovitinib in people with Adrenocortical Carcinoma, run by Spanish Oncology Genito-Urinary Group at 7 sites in Spain.

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 9 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 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Spain. 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?

Efficacy (time frame: Up to 6 months (Study treatment expected duration)). 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 NCT01514526.

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 25 Apr 2017.

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