Trial Outcomes & Findings for Saracatinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer (NCT NCT00513435)
NCT ID: NCT00513435
Last Updated: 2014-04-30
Results Overview
Response was determined as inicated in the protocol.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
From the start of treatment for up to 12 weeks
Results posted on
2014-04-30
Participant Flow
Protocol Open to Accrual 08/22/2006 Protocol Closed to Accrual 07/14/2009 Primary Completion Date 03/08/2011 Recruitment Location is the medical clinic
Participant milestones
| Measure |
Treatment (Enzyme Inhibitor Therapy)
Patients receive saracatinib 175 mg PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Saracatinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=9 Participants
Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
|
Age, Continuous
|
53.8 years
STANDARD_DEVIATION 13.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From the start of treatment for up to 12 weeksResponse was determined as inicated in the protocol.
Outcome measures
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=9 Participants
Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Response Rate
Stable Disease
|
1 participants
|
|
Overall Response Rate
Progression of Disease
|
8 participants
|
SECONDARY outcome
Timeframe: Up to 12 weeksThe Kaplan-Meier method will be used to estimate overall survival.
Outcome measures
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=9 Participants
Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival
|
180 Days
Interval 27.0 to 1605.0
|
Adverse Events
Treatment (Enzyme Inhibitor Therapy)
Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=9 participants at risk
Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
General disorders
Death not assoc w CTCAE term- Sudden death
|
33.3%
3/9 • Number of events 3
|
|
Blood and lymphatic system disorders
Lymphopenia
|
22.2%
2/9 • Number of events 2
|
|
Blood and lymphatic system disorders
Inf norm ANC/gr1/2 neut-Cellulitis(skin)
|
11.1%
1/9 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=9 participants at risk
Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Metabolism and nutrition disorders
Fatigue (asthenia, lethargy, malaise)
|
66.7%
6/9 • Number of events 14
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
44.4%
4/9 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhea
|
44.4%
4/9 • Number of events 7
|
|
Gastrointestinal disorders
Nausea
|
44.4%
4/9 • Number of events 4
|
|
Renal and urinary disorders
AST, SGOT
|
44.4%
4/9 • Number of events 4
|
|
Renal and urinary disorders
Alkaline phosphatase
|
44.4%
4/9 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
33.3%
3/9 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
3/9 • Number of events 3
|
|
Blood and lymphatic system disorders
Lymphopenia
|
22.2%
2/9 • Number of events 2
|
|
Blood and lymphatic system disorders
Platelets
|
22.2%
2/9 • Number of events 2
|
|
Metabolism and nutrition disorders
Creatinine
|
22.2%
2/9 • Number of events 2
|
|
Renal and urinary disorders
Proteinuria
|
22.2%
2/9 • Number of events 2
|
|
Nervous system disorders
Neuropathy: sensory
|
22.2%
2/9 • Number of events 2
|
|
Blood and lymphatic system disorders
Epistaxis
|
22.2%
2/9 • Number of events 2
|
Additional Information
Matthew Fury, MD
Memorial Sloan-Kettering Cancer Center
Phone: 646-888-4233
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60