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

NCT01678105 | Completed Phase 2 DMC

• 1 other identifier: OCOG-2012-DOVE
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 4

Brief 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 study in patients with progressive ACC.

Conditions

Recurrent Adenoid Cystic Carcinoma of the Salivary Glands; Metastatic Adenoid Cystic Carcinoma of the Salivary Glands; Salivary Gland Cancers; ACC

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

Outcome Measures

Primary Outcomes (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.

  2 years

Secondary Outcomes (3)

• Progression Free Survival

  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

• Overall Survival

  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

• Safety and tolerability

  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

Study Arms (1)

Dovitinib

EXPERIMENTAL

Dovitinib 500 mg PO OD (5 days on, 2 days off); Each cycle = 28 days

Drug: Dovitinib

Interventions

Dovitinib DRUG

Treatment continued until Disease Progression, Toxicity, or patient withdrawal

Also known as: TKI258, RTK Inhibitor

Dovitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• i) 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Ontario Clinical Oncology Group (OCOG): lead
• Novartis Pharmaceuticals: collaborator

Study Sites (4)

Tom Baker Cancer Centre

Calgary, Ontario, T2N 4N2, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

Salivary Gland Neoplasms

Interventions

4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-one

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases

Study Officials

• Sebastien Hotte, MD

  Juravinski Cancer Centre

  PRINCIPAL INVESTIGATOR

• Mark Levine, MD

  Ontario Clinical Oncology Group (OCOG)

  STUDY DIRECTOR

• Greg Pond, PhD

  Ontario Clinical Oncology Group (OCOG)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2012
• First Posted: September 3, 2012
• Study Start: November 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 17, 2015

Record last verified: 2015-09

Locations

CA (4)