Trial Outcomes & Findings for Sirolimus in Treating Patients With Advanced Pancreatic Cancer (NCT NCT00499486)

NCT ID: NCT00499486

Last Updated: 2016-10-19

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 47 participants
• Primary outcome timeframe: 6- month survival rate (6mSR)
• Results posted on: 2016-10-19

Participant Flow

During baseline evaluation (approximately 72 hours prior to treatment with rapamycin), patients will receive a single dose of 3 mg oral midazolam as phenotypic evaluation of CYP3A4 activity.

Participant milestones

Measure	Sirolimus Patients with advanced pancreatic adenocarcinoma refractory to gemcitibine received Sirolimus at a single oral flat dose of 5 mg. per day. A treatment cycle was 28 days.
Overall Study STARTED	47
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Measure	Sirolimus Patients with advanced pancreatic adenocarcinoma refractory to gemcitibine received Sirolimus at a single oral flat dose of 5 mg. per day. A treatment cycle was 28 days.
Overall Study Withdrawal by Subject	16

Baseline Characteristics

Sirolimus in Treating Patients With Advanced Pancreatic Cancer

Baseline characteristics by cohort

Measure	Sirolimus n=47 Participants adencarcinoma refractory to gemcitibine
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants
Age, Categorical >=65 years	22 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants
Region of Enrollment United States	47 participants n=5 Participants

PRIMARY outcome

Timeframe: 6- month survival rate (6mSR)

Outcome measures

Measure	One Group n=31 Participants Patients with advanced pancreatic adenocarcinoma refractory to gemcitabine
Percentage of Patients With Overall Survival at 6 Months	26 % of participants

PRIMARY outcome

Timeframe: response at 2 and 6 months

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; Progression, a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Response for Stable disease was assessed at 2 months and for complete and partial response at 6 months.

Outcome measures

Measure	One Group n=31 Participants Patients with advanced pancreatic adenocarcinoma refractory to gemcitabine
Response Rate (Complete, Partial Response and Stable Disease) as Assessed by RECIST complete and partial response at 6 months	0 participants
Response Rate (Complete, Partial Response and Stable Disease) as Assessed by RECIST stable disease at 2 months	4 participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	One Group n=31 Participants Patients with advanced pancreatic adenocarcinoma refractory to gemcitabine
Severity of Adverse Events as Assessed by NCI CTCAE v3.0 Grade 1	67 percentage of Adverse Events
Severity of Adverse Events as Assessed by NCI CTCAE v3.0 Grade 2	24 percentage of Adverse Events
Severity of Adverse Events as Assessed by NCI CTCAE v3.0 Grade 3	9 percentage of Adverse Events
Severity of Adverse Events as Assessed by NCI CTCAE v3.0 Grade 4	0 percentage of Adverse Events

Adverse Events

Sirolimus

Serious events: 7 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sirolimus n=31 participants at risk Treatment with rapamycin will begin on Day 1 at a single flat dose level of 5 mg/day. Rapamycin will be administered continuously without interruption through all cycles in an outpatient setting. Each cycle will last 28 days.
General disorders Failure to thrive	6.5% 2/31 • Number of events 2 • 6 months
Endocrine disorders Hyperglycemia	3.2% 1/31 • Number of events 1 • 6 months
Metabolism and nutrition disorders dehydration	9.7% 3/31 • Number of events 3 • 6 months
Vascular disorders Hypotension	3.2% 1/31 • Number of events 1 • 6 months

Other adverse events

Measure	Sirolimus n=31 participants at risk Treatment with rapamycin will begin on Day 1 at a single flat dose level of 5 mg/day. Rapamycin will be administered continuously without interruption through all cycles in an outpatient setting. Each cycle will last 28 days.
Metabolism and nutrition disorders elevated Alkaline Phosphatase	6.5% 2/31 • Number of events 2 • 6 months
Metabolism and nutrition disorders elevated ALT	12.9% 4/31 • Number of events 7 • 6 months
Blood and lymphatic system disorders Anemia	29.0% 9/31 • Number of events 11 • 6 months
Gastrointestinal disorders Anorexia	16.1% 5/31 • Number of events 7 • 6 months
Metabolism and nutrition disorders elevated AST	16.1% 5/31 • Number of events 8 • 6 months
Gastrointestinal disorders Constipation	9.7% 3/31 • Number of events 3 • 6 months
Respiratory, thoracic and mediastinal disorders cough	6.5% 2/31 • Number of events 2 • 6 months
Renal and urinary disorders elevated creatinine	6.5% 2/31 • Number of events 2 • 6 months
Metabolism and nutrition disorders dehydration	6.5% 2/31 • Number of events 3 • 6 months
Gastrointestinal disorders diarrhea	12.9% 4/31 • Number of events 4 • 6 months
General disorders Dry mouth	6.5% 2/31 • Number of events 2 • 6 months
Skin and subcutaneous tissue disorders Dry skin	6.5% 2/31 • Number of events 2 • 6 months
Skin and subcutaneous tissue disorders erythema	6.5% 2/31 • Number of events 2 • 6 months
General disorders fatigue	38.7% 12/31 • Number of events 12 • 6 months
Metabolism and nutrition disorders hyperglycemia	58.1% 18/31 • Number of events 26 • 6 months
Metabolism and nutrition disorders Hypocalcemia	6.5% 2/31 • Number of events 2 • 6 months
Metabolism and nutrition disorders Hypomagnesemia	6.5% 2/31 • Number of events 2 • 6 months
Metabolism and nutrition disorders hyponatremia	6.5% 2/31 • Number of events 2 • 6 months
Blood and lymphatic system disorders Leukopenia	38.7% 12/31 • Number of events 13 • 6 months
Blood and lymphatic system disorders lymphopenia	38.7% 12/31 • Number of events 15 • 6 months
Gastrointestinal disorders Mucositis	16.1% 5/31 • Number of events 7 • 6 months
Gastrointestinal disorders nausea	12.9% 4/31 • Number of events 4 • 6 months
Blood and lymphatic system disorders Neutropenia	38.7% 12/31 • Number of events 12 • 6 months
Gastrointestinal disorders abdominal pain	19.4% 6/31 • Number of events 6 • 6 months
Blood and lymphatic system disorders thrombocytopenia	38.7% 12/31 • Number of events 12 • 6 months
Skin and subcutaneous tissue disorders pruritis	6.5% 2/31 • Number of events 2 • 6 months
Skin and subcutaneous tissue disorders rash	45.2% 14/31 • Number of events 14 • 6 months
Gastrointestinal disorders vomiting	9.7% 3/31 • Number of events 3 • 6 months
Metabolism and nutrition disorders hyperchoesterolaemia	6.5% 2/31 • Number of events 2 • 6 months

Additional Information

Dr. Hidalgo

The Sidney Kimmel Comprehensive Cancer Centre at Johns Hopkins

Email: mhidalgo@cnio.es

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place