Trial Outcomes & Findings for Lapatinib in Treating Patients With Recurrent and/or Metastatic Adenoid Cystic Cancer or Other Salivary Gland Cancers (NCT NCT00095563)
NCT ID: NCT00095563
Last Updated: 2017-04-18
Results Overview
Per Response - Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions;
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2017-04-18
Participant Flow
1 enrolled patient was a screen failure.
Participant milestones
| Measure |
Treatment (Lapatinib Ditosylate)
Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
lapatinib ditosylate: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lapatinib in Treating Patients With Recurrent and/or Metastatic Adenoid Cystic Cancer or Other Salivary Gland Cancers
Baseline characteristics by cohort
| Measure |
Treatment (Lapatinib Ditosylate)
n=40 Participants
Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
lapatinib ditosylate: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=93 Participants
|
|
Age, Continuous
|
57 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=93 Participants
|
|
Region of Enrollment
Canada
|
40 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: 36 assessable participants.
Per Response - Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions;
Outcome measures
| Measure |
Treatment (Lapatinib Ditosylate)
n=36 Participants
Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
lapatinib ditosylate: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Objective Response Rates (Partial and Complete Responses)
|
0 participants
|
SECONDARY outcome
Timeframe: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 yearsPopulation: This assessment was not performed since no participants showed a response.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: 36 assessable participants, 19 with ACC and 17 with non-ACC.
Number of patients who had Stable disease for more than or equal to 6 months together in both Adenoid cystic carcinoma (ACC) and non-adenoid cyctic carcinoma (non-ACC)
Outcome measures
| Measure |
Treatment (Lapatinib Ditosylate)
n=36 Participants
Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
lapatinib ditosylate: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Rate of Stable Disease
ACC
|
9 participants
|
|
Rate of Stable Disease
Non-ACC
|
4 participants
|
SECONDARY outcome
Timeframe: From the date of study enrolment to disease progression, death or last contact, or last tumor assessment before the start of further anti-tumor therapy, assessed up to 5 yearsPopulation: 36 assessable participants, 19 with ACC and 17 with non-ACC.
Outcome measures
| Measure |
Treatment (Lapatinib Ditosylate)
n=36 Participants
Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
lapatinib ditosylate: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Progression-free Survival (PFS) According to RECIST
ACC
|
3.6 months
Interval 3.1 to 12.4
|
|
Progression-free Survival (PFS) According to RECIST
Non-ACC
|
2.1 months
Interval 1.6 to 9.2
|
SECONDARY outcome
Timeframe: From the date of study enrolment to death or last contact, assessed up to 5 yearsPopulation: 20 participants with ACC, 19 participants with non-ACC.
Survival estimates will be computed using the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Lapatinib Ditosylate)
n=39 Participants
Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
lapatinib ditosylate: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Survival (OS)
Non-ACC
|
16.5 months
Interval 9.1 to 30.9
|
|
Overall Survival (OS)
ACC
|
NA months
Not reached
|
SECONDARY outcome
Timeframe: Up to 5 yearsNumber of participants that experienced the most frequent adverse events of grade 1-2 by CTCAE grading.
Outcome measures
| Measure |
Treatment (Lapatinib Ditosylate)
n=39 Participants
Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
lapatinib ditosylate: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Most Frequent Adverse Events of Grade 1-2 by CTCAE Grading
Diarrhea
|
26 participants
|
|
Most Frequent Adverse Events of Grade 1-2 by CTCAE Grading
Fatigue
|
28 participants
|
|
Most Frequent Adverse Events of Grade 1-2 by CTCAE Grading
Rash
|
19 participants
|
Adverse Events
Treatment (Lapatinib Ditosylate)
Serious events: 6 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Lapatinib Ditosylate)
n=39 participants at risk
Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
lapatinib ditosylate: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
2.6%
1/39
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
2.6%
1/39
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.1%
2/39
|
|
Ear and labyrinth disorders
Hearing loss
|
2.6%
1/39
|
|
Renal and urinary disorders
Ureteric obstruction
|
2.6%
1/39
|
|
Investigations
Weight gain
|
2.6%
1/39
|
|
Injury, poisoning and procedural complications
Fracture
|
2.6%
1/39
|
|
Vascular disorders
Hypertension
|
2.6%
1/39
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.6%
1/39
|
Other adverse events
| Measure |
Treatment (Lapatinib Ditosylate)
n=39 participants at risk
Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
lapatinib ditosylate: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
5.1%
2/39
|
|
Gastrointestinal disorders
Abdominal pain
|
10.3%
4/39
|
|
Investigations
Activated partial thromboplastin time prolonged
|
10.3%
4/39
|
|
Investigations
Alanine aminotransferase increased
|
20.5%
8/39
|
|
Investigations
Alkaline phosphatase increased
|
30.8%
12/39
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
12.8%
5/39
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.3%
4/39
|
|
Metabolism and nutrition disorders
Anorexia
|
25.6%
10/39
|
|
Psychiatric disorders
Anxiety
|
10.3%
4/39
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.6%
1/39
|
|
Investigations
Aspartate aminotransferase increased
|
30.8%
12/39
|
|
Nervous system disorders
Ataxia
|
2.6%
1/39
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.9%
7/39
|
|
Investigations
Bilirubin increased
|
15.4%
6/39
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
41.0%
16/39
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
5.1%
2/39
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.3%
4/39
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
2.6%
1/39
|
|
Nervous system disorders
Burning in feet
|
2.6%
1/39
|
|
Gastrointestinal disorders
Cheilitis
|
5.1%
2/39
|
|
General disorders
Chest pain
|
15.4%
6/39
|
|
General disorders
Chest wall pain
|
5.1%
2/39
|
|
Investigations
Coagulopathy - PT
|
2.6%
1/39
|
|
Gastrointestinal disorders
Constipation
|
17.9%
7/39
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
35.9%
14/39
|
|
Investigations
Creatinine increased
|
10.3%
4/39
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cyst on back
|
2.6%
1/39
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
1/39
|
|
Psychiatric disorders
Depression
|
7.7%
3/39
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
2.6%
1/39
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
26/39
|
|
Eye disorders
Diplopia
|
2.6%
1/39
|
|
Nervous system disorders
Dizziness
|
10.3%
4/39
|
|
Eye disorders
Dry eye syndrome
|
2.6%
1/39
|
|
Gastrointestinal disorders
Dry lips
|
2.6%
1/39
|
|
Gastrointestinal disorders
Dry mouth
|
7.7%
3/39
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
30.8%
12/39
|
|
Gastrointestinal disorders
Dyspepsia
|
28.2%
11/39
|
|
Gastrointestinal disorders
Dysphagia
|
15.4%
6/39
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
46.2%
18/39
|
|
Renal and urinary disorders
Dysuria
|
5.1%
2/39
|
|
General disorders
Ear, nose and throat examination abnormal
|
10.3%
4/39
|
|
Gastrointestinal disorders
Early Satiety
|
2.6%
1/39
|
|
General disorders
Edema limbs
|
12.8%
5/39
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.6%
1/39
|
|
Ear and labyrinth disorders
External ear inflammation
|
5.1%
2/39
|
|
Infections and infestations
Eye infection
|
5.1%
2/39
|
|
Eye disorders
Eye pain
|
2.6%
1/39
|
|
Nervous system disorders
Facial nerve disorder
|
2.6%
1/39
|
|
General disorders
Facial pain
|
7.7%
3/39
|
|
General disorders
Fatigue
|
71.8%
28/39
|
|
General disorders
Fever
|
5.1%
2/39
|
|
General disorders
Flu-like symptoms
|
2.6%
1/39
|
|
Vascular disorders
Flushing
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
2.6%
1/39
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.6%
1/39
|
|
Nervous system disorders
Headache
|
25.6%
10/39
|
|
Ear and labyrinth disorders
Hearing loss
|
10.3%
4/39
|
|
Investigations
Hemoglobin decreased
|
51.3%
20/39
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
12.8%
5/39
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.1%
2/39
|
|
Investigations
INR increased
|
2.6%
1/39
|
|
Psychiatric disorders
Insomnia
|
28.2%
11/39
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
7.7%
3/39
|
|
Infections and infestations
Kidney infection
|
2.6%
1/39
|
|
Injury, poisoning and procedural complications
Knee injury
|
2.6%
1/39
|
|
Respiratory, thoracic and mediastinal disorders
Laryngitis
|
2.6%
1/39
|
|
Infections and infestations
Left Ear Drainage
|
2.6%
1/39
|
|
Cardiac disorders
Left ventricular failure
|
2.6%
1/39
|
|
Blood and lymphatic system disorders
Leukocyte count decreased
|
28.2%
11/39
|
|
General disorders
Localized edema
|
2.6%
1/39
|
|
Eye disorders
Loss Of Peripheral Vision
|
2.6%
1/39
|
|
Investigations
Lymphocyte count decreased
|
64.1%
25/39
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
2.6%
1/39
|
|
Infections and infestations
Mucosal infection
|
2.6%
1/39
|
|
Gastrointestinal disorders
Mucositis oral
|
20.5%
8/39
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.3%
4/39
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
7.7%
3/39
|
|
Infections and infestations
Nail infection
|
7.7%
3/39
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.3%
4/39
|
|
Gastrointestinal disorders
Nausea
|
41.0%
16/39
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.8%
5/39
|
|
Musculoskeletal and connective tissue disorders
Neck soft tissue necrosis
|
2.6%
1/39
|
|
Nervous system disorders
Neuralgia
|
5.1%
2/39
|
|
Investigations
Neutrophil count decreased
|
17.9%
7/39
|
|
Nervous system disorders
Nystagmus
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Onycolysis
|
2.6%
1/39
|
|
Nervous system disorders
Optic nerve disorder
|
2.6%
1/39
|
|
Gastrointestinal disorders
Oral pain
|
2.6%
1/39
|
|
Ear and labyrinth disorders
Otitis externa
|
2.6%
1/39
|
|
Infections and infestations
Pain
|
2.6%
1/39
|
|
Musculoskeletal and connective tissue disorders
Pain - hands
|
2.6%
1/39
|
|
Musculoskeletal and connective tissue disorders
Pain - hip
|
5.1%
2/39
|
|
Musculoskeletal and connective tissue disorders
Pain - jaw
|
2.6%
1/39
|
|
Musculoskeletal and connective tissue disorders
Pain - left jaw
|
2.6%
1/39
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.1%
2/39
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
30.8%
12/39
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.6%
1/39
|
|
Infections and infestations
Plantar Wart
|
2.6%
1/39
|
|
Investigations
Platelet count decreased
|
5.1%
2/39
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
17.9%
7/39
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
2.6%
1/39
|
|
Nervous system disorders
Pyramidal tract syndrome
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
48.7%
19/39
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
12.8%
5/39
|
|
Gastrointestinal disorders
Salivation
|
2.6%
1/39
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second Malignancy, Supraglottic Cancer
|
2.6%
1/39
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
7.7%
3/39
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
7.7%
3/39
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
12.8%
5/39
|
|
Investigations
Serum cholesterol increased
|
5.1%
2/39
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
2.6%
1/39
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
5.1%
2/39
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
17.9%
7/39
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
12.8%
5/39
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
2.6%
1/39
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
12.8%
5/39
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
5.1%
2/39
|
|
Cardiac disorders
Sinus bradycardia
|
5.1%
2/39
|
|
Cardiac disorders
Sinus tachycardia
|
2.6%
1/39
|
|
Infections and infestations
Sinusitis
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Skin change
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Skin-Carbuncle
|
2.6%
1/39
|
|
Nervous system disorders
Speech disorder
|
2.6%
1/39
|
|
Nervous system disorders
Taste alteration
|
15.4%
6/39
|
|
Injury, poisoning and procedural complications
Thermal burn
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Thinner Skin Finger Tips
|
2.6%
1/39
|
|
Ear and labyrinth disorders
Tinnitus
|
2.6%
1/39
|
|
Infections and infestations
Tooth infection
|
2.6%
1/39
|
|
Gastrointestinal disorders
Toothache
|
5.1%
2/39
|
|
Nervous system disorders
Tremor
|
5.1%
2/39
|
|
Nervous system disorders
Trigeminal nerve disorder
|
2.6%
1/39
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
2.6%
1/39
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
2.6%
1/39
|
|
Gastrointestinal disorders
Ulceration - medical intervention not indicated
|
2.6%
1/39
|
|
Infections and infestations
Upper aerodigestive tract infection
|
2.6%
1/39
|
|
Infections and infestations
Upper respiratory infection
|
7.7%
3/39
|
|
Renal and urinary disorders
Ureteric obstruction
|
2.6%
1/39
|
|
Renal and urinary disorders
Urinary frequency
|
7.7%
3/39
|
|
Renal and urinary disorders
Urinary incontinence
|
2.6%
1/39
|
|
Renal and urinary disorders
Urinary tract infection
|
5.1%
2/39
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.6%
1/39
|
|
Reproductive system and breast disorders
Vaginal discharge
|
2.6%
1/39
|
|
Reproductive system and breast disorders
Vaginal dryness
|
2.6%
1/39
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
2.6%
1/39
|
|
Eye disorders
Vision blurred
|
5.1%
2/39
|
|
Eye disorders
Vision Changes
|
2.6%
1/39
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
10.3%
4/39
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
6/39
|
|
Eye disorders
Watering eyes
|
2.6%
1/39
|
|
Investigations
Weight gain
|
2.6%
1/39
|
|
Investigations
Weight loss
|
7.7%
3/39
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60