Trial Outcomes & Findings for Saracatinib in Treating Patients With Previously Treated Metastatic Pancreatic Cancer (NCT NCT00735917)
NCT ID: NCT00735917
Last Updated: 2019-04-02
Results Overview
The proportion of successes will be estimated by the number of surviving participants at 6 months divided by the total number of evaluable patients. A confidence interval for the 6-month survival rate was calculated using the exact binomial method.
COMPLETED
PHASE2
19 participants
Up to 6 months
2019-04-02
Participant Flow
Nineteen patients with gemcitabine-resistant metastatic pancreatic cancer were enrolled from four U.S. locations from October 2008 to January 2011.
All 19 patients accrued to this study were used to report endpoints.
Participant milestones
| Measure |
Treatment (Saracatinib)
Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Saracatinib in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Saracatinib)
n=19 Participants
Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsThe proportion of successes will be estimated by the number of surviving participants at 6 months divided by the total number of evaluable patients. A confidence interval for the 6-month survival rate was calculated using the exact binomial method.
Outcome measures
| Measure |
Treatment (Saracatinib)
n=19 Participants
Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Six Month Survival
|
11 percentage of patients
Interval 1.0 to 33.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsOverall survival time is defined as the time from registration to death due to any cause. The median survival time and 95% confidence intervals will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Treatment (Saracatinib)
n=19 Participants
Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival
|
2.5 months
Interval 1.3 to 3.6
|
SECONDARY outcome
Timeframe: Evaluated using the first 6 courses of treatmentA confirmed tumor response is defined to be a CR or PR noted as\> the objective status on 2 consecutive evaluations at least 4 weeks apart. Response will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)\> \> Complete Response (CR): Disappearance of all non-nodal target lesions and each target lymph node must have a reduction in short axis to \<1.0 centimeters.\> \> Partial response (PR): At least a 30% decrease in the sum of the longest diameters of the non-nodal target lesions and the short axes of the target lymph nodes taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Treatment (Saracatinib)
n=19 Participants
Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Confirmed Tumor Responses (Complete Response [CR] or Partial Response [PR])
|
0 participants
|
SECONDARY outcome
Timeframe: From the date first objective status is noted to be either a CR or PR to the date progression is documented, assessed up to 2 yearsPopulation: No patients qualified for a confirmed response and therefore this endpoint was not analyzed.
Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented. Estimated by the method of Kaplan-Meier.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Progression and survival status assessed every month, up to 2 yearsTime from the date of registration to the date of progression or death, whichever occurs first. Estimated by the method of Kaplan-Meier.
Outcome measures
| Measure |
Treatment (Saracatinib)
n=19 Participants
Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Progression-Free Survival
|
1.6 months
Interval 0.9 to 1.8
|
Adverse Events
Treatment (Saracatinib)
Serious adverse events
| Measure |
Treatment (Saracatinib)
n=19 participants at risk
Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
15.8%
3/19 • Number of events 3
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
10.5%
2/19 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
21.1%
4/19 • Number of events 4
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
21.1%
4/19 • Number of events 4
|
|
General disorders
Disease progression
|
10.5%
2/19 • Number of events 2
|
|
General disorders
Fatigue
|
15.8%
3/19 • Number of events 3
|
|
Hepatobiliary disorders
Gallbladder perforation
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Biliary tract infection
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Infection
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Sepsis
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Alkaline phosphatase increased
|
10.5%
2/19 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
10.5%
2/19 • Number of events 2
|
|
Investigations
Bilirubin increased
|
15.8%
3/19 • Number of events 3
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.3%
1/19 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
10.5%
2/19 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
1/19 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
10.5%
2/19 • Number of events 2
|
|
Renal and urinary disorders
Cystitis
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.5%
2/19 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
5.3%
1/19 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Saracatinib)
n=19 participants at risk
Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
63.2%
12/19 • Number of events 16
|
|
Gastrointestinal disorders
Abdominal pain
|
10.5%
2/19 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
21.1%
4/19 • Number of events 5
|
|
Gastrointestinal disorders
Dry mouth
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Duodenal ulcer
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
42.1%
8/19 • Number of events 10
|
|
Gastrointestinal disorders
Vomiting
|
15.8%
3/19 • Number of events 3
|
|
General disorders
Chills
|
10.5%
2/19 • Number of events 2
|
|
General disorders
Fatigue
|
47.4%
9/19 • Number of events 13
|
|
General disorders
Fever
|
15.8%
3/19 • Number of events 3
|
|
Hepatobiliary disorders
Hepatic failure
|
10.5%
2/19 • Number of events 2
|
|
Investigations
Activated partial thromboplastin time prolonged
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
15.8%
3/19 • Number of events 3
|
|
Investigations
Alkaline phosphatase increased
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
15.8%
3/19 • Number of events 3
|
|
Investigations
Bilirubin increased
|
15.8%
3/19 • Number of events 3
|
|
Investigations
Creatinine increased
|
21.1%
4/19 • Number of events 4
|
|
Investigations
INR increased
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
10.5%
2/19 • Number of events 2
|
|
Investigations
Lymphocyte count decreased
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Platelet count decreased
|
15.8%
3/19 • Number of events 3
|
|
Metabolism and nutrition disorders
Anorexia
|
10.5%
2/19 • Number of events 2
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
10.5%
2/19 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
10.5%
2/19 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
10.5%
2/19 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
5.3%
1/19 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
5.3%
1/19 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
5.3%
1/19 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
26.3%
5/19 • Number of events 6
|
|
Renal and urinary disorders
Protein urine positive
|
10.5%
2/19 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.3%
1/19 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
10.5%
2/19 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60