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

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Brief Title

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

Official Title

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

Brief 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.

        -  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.
    

Detailed Description

      Non applicable
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Efficacy

Secondary Outcome

 Safety profile of dovitinib in study population

Condition

Adrenocortical Carcinoma

Intervention

Dovitinib

Study Arms / Comparison Groups

 Dovitinib
Description:  Dovitinib (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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

17

Start Date

January 2012

Completion Date

November 2016

Primary Completion Date

July 2013

Eligibility Criteria

        Inclusion Criteria:

          -  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.

          -  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.

        Exclusion Criteria:

          -  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:

               -  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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jesús García-Donás Jiménez, MD, , 

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT01514526

Organization ID

SOGUG2011-03

Secondary IDs

2011-002873-47

Responsible Party

Sponsor

Study Sponsor

Spanish Oncology Genito-Urinary Group


Study Sponsor

Jesús García-Donás Jiménez, MD, Principal Investigator, Spanish Oncology Genito-Urinary Group


Verification Date

April 2016