Clinical Trial of Dovitinib in First-line Metastatic or Locally Advanced Non-resectable Adrenocor… (NCT01514526) | Clinical Trial Compass
CompletedPhase 2
Clinical Trial of Dovitinib in First-line Metastatic or Locally Advanced Non-resectable Adrenocortical Carcinoma
Spain17 participantsStarted 2012-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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chemotherapy other than mitotane (Patients who have previously received mitotane will only be eligible if drig has been withdrawn at least two weeks earlier than dovitinib first dose is administered).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 fo…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy
Timeframe: Up to 6 months (Study treatment expected duration)