AzTrials
AzTrials

Recurrent Adenoid Cystic Carcinoma of the Salivary GlandsPhase 2DOVENCT01678105

A Phase II Study of Dovitinib in Recurrent and/or Metastatic Adenoid Cystic Carcinoma of the Salivary Glands

A Phase 2 study testing Dovitinib in people with Recurrent Adenoid Cystic Carcinoma of the Salivary Glands and Metastatic Adenoid Cystic Carcinoma of the Salivary Glands, run by Ontario Clinical Oncology Group (OCOG) at 4 sites in Canada.

Completed

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

Official record
Search all trials

Trial summary

This is a non-randomized, phase II, open label study of dovitinib in patients with progressive, recurrent and/or metastatic adenoid cystic carcinoma (ACC). The primary purpose of this study is to assess the anti-cancer effects of dovitinib in this population in order to evaluate whether dovitinib is worthy of further… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dovitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
4 sitesCanada
Study dates
Nov 2012to Sep 2015
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

  • Histologically or cytologically confirmed ACC of major or minor salivary glands.
  • Recurrent and/or metastatic disease deemed progressive that is not amenable to surgery or curative radiotherapy.
  • Measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1), defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter in the plane of measurement is to be recorded) with a minimum size of:
  • > 10 mm by CT scan (CT scan slice thickness no greater than 5 mm).
  • > 10 mm caliper measurement by clinical exam (lesion which cannot be accurately measured with calipers should be recorded as non-measurable).
  • > 20 mm by chest X-ray Malignant lymph nodes: To be considered pathologically enlarged and measurable, a lymph node must be >15mm in short axis when assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 mm).
  • Progressive disease, defined as one of the following occurring within 12 months of study entry:
  • at least a 10% increase in radiologically or clinically measurable disease; ii) appearance of one or more new lesions, or iii) deterioration in clinical status.

Who cannot join

  • Less than 18 years of age.
  • Life expectancy < 12 weeks.
  • ECOG performance status > 2.
  • Known brain metastases.
  • Treatment with chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  • Major surgery within 4 weeks prior to entering the study.
Show all 35Show fewer
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to dovitinib.
  • Taking medications that are potent CYP3A4 inducers or inhibitors (dovitinib is metabolized primarily by the CYP3A4 liver enzyme, every effort should be made to switch patients taking such agents or substances to other medications).
  • History of cardiac dysfunction with an ECHO or MUGA scan outside the institutional range of normal.
  • QTc prolongation (defined as a QTc interval > 500 msec) or other significant ECG abnormalities.
  • Poorly controlled hypertension (systolic blood pressure of ≥ 140 mmHg or diastolic blood pressure of ≥ 90 mmHg).
  • Any abnormal organ and marrow function as defined below:
  • Leukocytes <3,000/microL
  • Absolute neutrophil count <1,500/microL
  • Platelets <100,000/microL
  • Total bilirubin >1.5X institutional upper limit of normal (ULN)
  • AST(SGOT) / ALT(SGPT) >2.5X institutional ULN
  • Amylase/lipase outside normal institutional limits
  • Serum creatinine >1.5X ULN
  • Creatinine clearance <60mL/min/1.73 m2 for patients with creatinine levels above institutional normal
  • Required use of therapeutic doses of coumarin-derivative anticoagulants such as warfarin, although doses of up to 2mg daily are permitted for prophylaxis of thrombosis. Note: Low molecular weight heparin is permitted provided the patient's PT INR is ≤ 1.5.
  • Pre-existing condition (e.g., gastrointestinal tract disease), resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease that impairs their ability to swallow and retain dovitinib tablets.
  • Pre-existing thyroid abnormality with an inability to maintain thyroid function in the normal range with medication.
  • Any of the following conditions:
  • Serious or non-healing wound, ulcer, or bone fracture,
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of treatment,
  • History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 12 months prior to study entry,
  • History of pulmonary embolism within the past 12 months,
  • History of myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within 12 months prior to study entry,
  • NYHA Class III or IV heart failure as defined by the NYHA functional classification system.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infections, HIV-positive patients on combination antiretroviral therapy.
  • Pregnant or lactating women.
  • Psychiatric illness/social situations that would limit compliance with study requirements.
  • Receiving any other investigational agent(s).
  • Inability to understand or unable to provide written informed consent.

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

  • Tom Baker Cancer Centre

    Calgary, Ontario, T2N 4N2

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • London Health Sciences Centre

    London, Ontario, N6A 4L6

  • Ottawa Hospital Regional Cancer Centre

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

About this study

Official title: A Phase II Study of DOVitinib in REcurrent and/or Metastatic Adenoid Cystic Carcinoma of the Salivary Glands (DOVE)

This is a non-randomized, phase II, open label study of dovitinib in patients with progressive, recurrent and/or metastatic adenoid cystic carcinoma (ACC). The primary purpose of this study is to assess the anti-cancer effects of dovitinib in this population in order to evaluate whether dovitinib is worthy of further study in patients with progressive ACC.

Being tested
Dovitinib
Keywords
Recurrent Adenoid Cystic Carcinoma of the Salivary Glands, Metastatic Adenoid Cystic Carcinoma of the Salivary Glands, Salivary Gland Cancers, ACC, Dovitinib, TKI258, RTK Inhibitor
Medical subject headings
Salivary Gland Neoplasms

What participants receive

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

  • DovitinibDrug

    Also called TKI258, RTK Inhibitor

    Treatment continued until Disease Progression, Toxicity, or patient withdrawal

Study groups in NCT01678105
Study groupRoleWhat they receive
DovitinibExperimentalDovitinib 500 mg PO OD (5 days on, 2 days off); Each cycle = 28 days
Receives: Drug: Dovitinib

What is being measured

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

  1. Clinical Benefit Rate

    The primary outcome measure is the clinical benefit rate, defined as an objective response (complete [CR] or partial [PR]) or stable disease [SD] of ≥6 months duration according to the RECIST version 1.1 criteria.

    Measured: 2 years

Secondary outcomes (3)

  1. Progression Free Survival

    Measured: From the date the patient first receives study medication to the date of death or date of progression according to RECIST or symptomatic deterioration; estimated to be after 12 weeks of treatment

  2. Overall Survival

    Measured: From the date the patient first receives study medication to the date of death; patients will be followed up for survival for up to 2 years after disease progression

  3. Safety and tolerability

    Patients will be evaluated for toxicity. Frequency and severity of adverse events will be tabulated using counts and proportions detailing frequently occuring, serious and severe events of interest.

    Measured: From the date the patient first receives study medication to the date the patient completes the study; patients will be followed up for survival for up to 2 years after disease progression

Timeline

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

  1. First posted3 Sep 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionSep 2015
  4. Study completionSep 2015

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
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01678105
Sponsor's protocol ID
OCOG-2012-DOVE
Acronym
DOVE
Status last verified
Sep 2015
First submitted
23 Aug 2012
Last updated
17 Sep 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dovitinib in people with Recurrent Adenoid Cystic Carcinoma of the Salivary Glands and Metastatic Adenoid Cystic Carcinoma of the Salivary Glands, run by Ontario Clinical Oncology Group (OCOG) at 4 sites in Canada.

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 8 inclusion and 35 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 17 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. 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?

Clinical Benefit Rate (time frame: 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 NCT01678105.

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 17 Sep 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in