Adenoid Cystic CarcinomaPhase 2ACCNCT01524692
Study of Dovitinib (TKI258) in Adenoid Cystic Carcinoma
A Phase 2 study testing Dovitinib (TKI258) in people with Adenoid Cystic Carcinoma, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this study is to improve survival of patients with recurrent or metastatic Adenoid Cystic Carcinoma (ACC). This study will test the efficacy of the investigational drug, TKI258, in treating ACC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenoid Cystic Carcinoma
- What is being tested?
- Dovitinib (TKI258)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Dec 2015
- 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
- Patients eligible for inclusion in this study have to meet all of the following criteria:
- Patients must have histology or cytology studies that confirm the diagnosis of adenoid cystic carcinoma. (Note: Subsequent central review of the pathology slides will be provided by Drs. Christopher Moskaluk or Henry Frierson, Department of Pathology at the University of Virginia Health Sciences Center).
- Patients must have recurrent and/or metastatic disease that is not amenable to potentially curative surgical resection or radiotherapy.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >10 mm with spiral CT scan (or >20 mm with conventional techniques). Pathologic lymph nodes are measured by shortest diameter as per RECIST.
- Patients must have serial imaging that allows measurement of tumor growth rates by change point analysis:
- 1. The remote baseline study scan must be within six calendar months of the immediate pre-study scan.
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- 2. The remote baseline scan must have measurable disease ≥ 10 mm for non-pulmonary lesions or ≥ 4 mm for pulmonary metastases that show subsequent progression.
- 3. Comparison of the remote baseline and subsequent studies must show progressive disease in 1-5 selected target lesions based on the following:
- Modified RECIST criteria (i.e. proportional increase of 1.2 or the appearance of new lesions) AND/OR
- Progression by change point analysis with an increase in the slope of the average tumor measurements of at least 0.22 b
- a = "remote baseline scan" refers to scan done prior to pre-study scan which is used to determine pre-treatment tumor growth rate.
- b = the estimated mean minus one standard deviation based on analysis of progressive tumors from untreated patients with ACC.
- 5. Life expectancy > 16 weeks.
- 6. ECOG (WHO) performance status 0-2
- 7. Age ≥ 18 years old
- 8. Patients must have the following laboratory values:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelets ≥ 100 x 109/L
- Hemoglobin (Hgb) > 9 g/dL
- Serum total bilirubin: ≤ 1.5 x ULN
- ALT and AST ≤ 3.0 x ULN
- Serum creatinine ≤ 1.5 x ULN or serum creatinine >1.5 - 3 x ULN if calculated creatinine clearance (CrCl) is ≥ 30 mL/min using the Cockroft-Gault equation, see formula below:
- CrCl = [140-age (years)] x weight (kg) / [72 x serum Cr (mg/dL)] (if patient is female multiply the above by 0.85)
- 9. Patients who give a written informed consent obtained according to local guidelines
Who cannot join
- Patients are ineligible for this study if he or she has any of the following:
- Patients with brain metastases
- Patients with another primary malignancy within 3 years prior to starting study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, or skin cancer (such as basal cell carcinoma, squamous cell carcinoma, or non-melanomatous skin cancer)
- Patients who have received the last administration of an anticancer therapy including chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies (but excluding nitrosurea, mitomycin-C, targeted therapy and radiation) ≤ 4 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy
- Patients who have received the last administration of nitrosurea or mitomycin-C ≤ 6 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy
- Patients who have received targeted therapy (e.g. sunitinib, sorafenib, pazopanib) ≤ 2 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy
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- Patients who have had radiotherapy ≤ 4 weeks prior to starting study drug or ≤ 2 weeks prior to starting study drug in the case of localized radiotherapy (e.g. for analgesic purpose or for lytic lesions at risk of fracture), if the measurable lesions are outside the radiation field. Also excluded would be those who have not recovered from toxicity radiotherapy.
- Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury ≤ 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤ 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury
- Patients with any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:
- 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 assessed by 2-D echocardiogram (ECHO) or multiple gated acquisition scan (MUGA) < 45%
- Any of the following within 6 months prior to starting study drug: myocardial infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Pulmonary Embolism (PE)
- Uncontrolled hypertension defined by a SBP ≥ 160 mm Hg and/or DBP ≥ 100 mm Hg, with or without anti-hypertensive medication(s)
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of dovitinib (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
- Cirrhosis, chronic active hepatitis or chronic persistent hepatitis
- Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)
- Patients who are currently receiving anticoagulation treatment with therapeutic doses of warfarin
- Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol
- Pregnant or breast-feeding women
- Women of child-bearing potential not employing an effective method of birth control. Two birth control methods must be used throughout the trial and one month after the last dose of study drug (e.g. condom with spermicidal jelly, foam suppository or film; diaphragm with spermicide; male condom and diaphragm with spermicide). Contraceptives that are affected by cytochrome P450 interactions (e.g. oral, implantable, injectable, or intrauterine hormonal contraceptives) are 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 ≤ 7 days prior to starting study drug.
- Fertile males not willing to use contraception, as stated above
- Patients unwilling or unable to comply with the protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
Official title: A Phase II Pilot Study of Dovitinib (TKI258) in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma.
The purpose of this study is to improve survival of patients with recurrent or metastatic Adenoid Cystic Carcinoma (ACC). This study will test the efficacy of the investigational drug, TKI258, in treating ACC.
Read the detailed description
Adenoid cystic carcinoma (ACC) is an uncommon malignancy that arises in secretory glands. The most common sites for the disease are the major and minor salivary glands but these tumors may also arise in the nasal cavity, lacrimal gland, tracheobronchial tree, breast or vulva. The mainstay of treatment for localized ACC is surgical resection often followed by post-operative radiotherapy. Although this leads to an initially high rate of local control, the 5-year disease-free survival rate is 50-75%. In addition, a significant proportion of the patients develop distant metastases, most frequently in the lung. Compared to other malignancies, ACC tends to grow more slowly. Thus, patients often do well in the short-term but long-term prognosis remains guarded and most succumb to the disease within 10-15 years. To date, systemic therapies have proven to be largely ineffective against recurrent and metastatic ACC. Dovitinib is a broad-targeted-profiled RTK inhibitor active against these three RTKs (VEGF, FGF and PDGF) involved in tumor cell growth. Based on its potency as an inhibitor of these RTKs both in vitro and in vivo, and the compound's oral availability, several clinical trials of dovitinib are underway. This phase II trial will test the hypothesis that dovitinib will be active against this disease. The rationale is based on pre-clinical studies that suggest that dovitinib suppresses tumor growth by blocking constitutive signaling of the fibroblast growth factor receptor-1 (FGFR1) and animal studies in which the drug proved to be active against primary ACC xenografts.
- Conditions
- Adenoid Cystic Carcinoma
- Being tested
- Dovitinib (TKI258)
- Medical subject headings
- Carcinoma, Adenoid Cystic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dovitinib (TKI258)Drug
500 mg orally on a 5-days on/2-days off schedule each week of a 4-week (28-day) cycle. Treatment will continue until progression as defined by RECIST, unacceptable adverse events, patient refusal to continue on study, or physician's decision to withdraw the patient.
| Study group | Role | What they receive |
|---|---|---|
| Single ARM Dovitinib treatment | Experimental | Single ARM Dovitinib treatment Receives: Drug: Dovitinib (TKI258) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the Objective Tumor Response Rate Following Treatment With TKI258
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by cross sectional imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: From enrollment up to 36months
Secondary outcomes (5)
Estimate the Progression-free Survival Following Treatment With TKI258.
PFS is measured from enrollment up to first progression event (median= 8.2 months). 1 patient was not evaluable for response evaluation due to withdrawal prior to first interval scan.
Measured: From enrollment up to first progression event
The Adverse Event Profile of TKI258 in Subjects Who Have ACC.
Adverse events were collected per CTCAE v3.
Measured: From enrollment up to 36months
Quality of Life Measurements During TKI258 Treatment.
Participants were asked to fill out FACT-G (Functional Assessment of Chronic Illness Therapy) quality of life questionnaires at baseline and off-treatment visit (average 8.2 months). This scale measures physical well-being, social/family well-being, emotional well-being, and functional well-being on a 5 point Likert scale. Scores range from 0 to 4 on a Likert scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The raw score range for each subscale is 0-28 points and the total score range is 0-108. Higher values represent higher well-being in each functional subscale. The mean difference from baseline to off-study assessment are presented with range from minimum to maximum.
Measured: Baseline FACT-G questionnaire and FACT-G questionnaire at time of off-treatment visit (average of 8.2 months)
Feasibility of Measuring and Analyzing TKI258 Induced Changes in the Growth Rate of Adenoid Cystic Carcinomas.
Collect descriptive data about the change in tumor growth rates as measured by the change point method. Tumor growth rate is defined as the estimated slope (slope is then defined as Y1-Y0 divided by X1-X0) from tumor measurements taken prior to treatment (TG0). TG0 is compared with TG1 (tumor growth rate) as defined by the estimated slope after treatment (comparing time 0 to 4mo). Each patient's tumor growth profile is allowed one slope measured from pre-study (-6 months to time 0), and the other slope (time 0 to time 4 months). Change between those 2 slopes is reported. Slope is measured on a plot of time on the x axis and sum of longest diameters of RECIST target lesions on the y axis. The slope of the tumor growth curve (plotted as sum of longest diameters vs month since starting dovitinib) is measured at time points -6mo, 0, and 4 months. Pre-study scans (-6mo) were required of all patients and on-study scans were at times, 0, 2, 4months, 8months, 12mo, 16mo.
Measured: All patients provided pre-study scans with target lesions. The target lesions from pre-study scans were compared to the target lesions on the baseline scan at time 0. TG0 was measured from -6 months to time 0. TG1 is defined as time 0 to time 4 months.
Expression of MYB Protein and Chromosomal Rearrangements of the MYB Locus
Assess archival tumor samples for the expression of MYB protein and chromosomal rearrangements of the MYB locus.
Measured: Anticipated Reporting Date 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionJan 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adenoid Cystic CarcinomaStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Principal investigator, Patrick Dillon, MD, University of Virginia
- Investigators
- Patrick Dillon, MD, Principal investigator, University of Virginia Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524692
- Sponsor's protocol ID
- 15627
- Acronym
- ACC
- Status last verified
- Oct 2018
- First submitted
- 17 Jan 2012
- Last updated
- 9 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Pilot Study of Dovitinib (TKI258) in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma.
- ClinicalTrials.gov ID
- NCT01524692
- Acronym / sponsor ID
- ACC / 15627
- Conditions
- Adenoid Cystic Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Mar 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 2 Feb 2012 (estimated)
- Results
- Posted 7 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to improve survival of patients with recurrent or metastatic Adenoid Cystic Carcinoma (ACC). This study will test the efficacy of the investigational drug, TKI258, in treating ACC.
Detailed description
Adenoid cystic carcinoma (ACC) is an uncommon malignancy that arises in secretory glands. The most common sites for the disease are the major and minor salivary glands but these tumors may also arise in the nasal cavity, lacrimal gland, tracheobronchial tree, breast or vulva. The mainstay of treatment for localized ACC is surgical resection often followed by post-operative radiotherapy. Although this leads to an initially high rate of local control, the 5-year disease-free survival rate is 50-75%. In addition, a significant proportion of the patients develop distant metastases, most frequently in the lung. Compared to other malignancies, ACC tends to grow more slowly. Thus, patients often do well in the short-term but long-term prognosis remains guarded and most succumb to the disease within 10-15 years. To date, systemic therapies have proven to be largely ineffective against recurrent and metastatic ACC. Dovitinib is a broad-targeted-profiled RTK inhibitor active against these three RTKs (VEGF, FGF and PDGF) involved in tumor cell growth. Based on its potency as an inhibitor of these RTKs both in vitro and in vivo, and the compound's oral availability, several clinical trials of dovitinib are underway. This phase II trial will test the hypothesis that dovitinib will be active against this disease. The rationale is based on pre-clinical studies that suggest that dovitinib suppresses tumor growth by blocking constitutive signaling of the fibroblast growth factor receptor-1 (FGFR1) and animal studies in which the drug proved to be active against primary ACC xenografts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single ARM Dovitinib treatment | Experimental | Drug: Dovitinib (TKI258)Single ARM Dovitinib treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Patients must have histology or cytology studies that confirm the diagnosis of adenoid cystic carcinoma. (Note: Subsequent central review of the pathology slides will be provided by Drs. Christopher Moskaluk or Henry Frierson, Department of Pathology at the University of Virginia Health Sciences Center).
- Patients must have recurrent and/or metastatic disease that is not amenable to potentially curative surgical resection or radiotherapy.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >10 mm with spiral CT scan (or >20 mm with conventional techniques). Pathologic lymph nodes are measured by shortest diameter as per RECIST.
- Patients must have serial imaging that allows measurement of tumor growth rates by change point analysis:
- 1. The remote baseline study scan must be within six calendar months of the immediate pre-study scan.
Key exclusion criteria (24 listed)
- Patients with brain metastases
- Patients with another primary malignancy within 3 years prior to starting study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, or skin cancer (such as basal cell carcinoma, squamous cell carcinoma, or non-melanomatous skin cancer)
- Patients who have received the last administration of an anticancer therapy including chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies (but excluding nitrosurea, mitomycin-C, targeted therapy and radiation) ≤ 4 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy
- Patients who have received the last administration of nitrosurea or mitomycin-C ≤ 6 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy
- Patients who have received targeted therapy (e.g. sunitinib, sorafenib, pazopanib) ≤ 2 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dovitinib (TKI258)500 mg orally on a 5-days on/2-days off schedule each week of a 4-week (28-day) cycle. Treatment will continue until progression as defined by RECIST, unacceptable adverse events, patient refusal to continue on study, or physician's decision to withdraw the patient. | Drug | Single ARM Dovitinib treatment |
Primary outcome
Determine the Objective Tumor Response Rate Following Treatment With TKI258
Time frame: From enrollment up to 36months
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by cross sectional imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
5 secondary outcomes
Estimate the Progression-free Survival Following Treatment With TKI258.
Time frame: From enrollment up to first progression event
The Adverse Event Profile of TKI258 in Subjects Who Have ACC.
Time frame: From enrollment up to 36months
Quality of Life Measurements During TKI258 Treatment.
Time frame: Baseline FACT-G questionnaire and FACT-G questionnaire at time of off-treatment visit (average of 8.2 months)
Feasibility of Measuring and Analyzing TKI258 Induced Changes in the Growth Rate of Adenoid Cystic Carcinomas.
Time frame: All patients provided pre-study scans with target lesions. The target lesions from pre-study scans were compared to the target lesions on the baseline scan at time 0. TG0 was measured from -6 months to time 0. TG1 is defined as time 0 to time 4 months.
Expression of MYB Protein and Chromosomal Rearrangements of the MYB Locus
Time frame: Anticipated Reporting Date 2020
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Dillon, MD principal investigator
University of Virginia Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dovitinib (TKI258) in people with Adenoid Cystic Carcinoma, run by University of Virginia at 1 site in United States.
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 24 inclusion and 24 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 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 7 May 2018). 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?
Determine the Objective Tumor Response Rate Following Treatment With TKI258 (time frame: From enrollment up to 36months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2018.