Trial Outcomes & Findings for Eribulin Mesylate as Second-Line Therapy for Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer Patients (NCT NCT00383760)

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: 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

15 participants

Primary outcome timeframe

Up to 3 years

Results posted on

2017-10-20

Participant Flow

Participant milestones

Participant milestones
Measure	E7389 Patients receive E7389 IV on days 1 and 8. eribulin mesylate: Given IV
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Eribulin Mesylate as Second-Line Therapy for Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Eribulin Mesylate) n=15 Participants Patients receive E7389 IV on days 1 and 8. eribulin mesylate: 1.4mg/m2 given IV weekly day 1,8 every 21 days (1 cycle).
Age, Continuous	62 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment Canada	15 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: 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

Outcome measures
Measure	Treatment (Eribulin Mesylate) n=15 Participants Patients receive E7389 IV on days 1 and 8. eribulin mesylate: Given IV
Objective Response (Complete and Partial) Evaluated Using RECIST Criteria	0 participants

SECONDARY outcome

Timeframe: Up to 3 years

Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Outcome measures

Outcome measures
Measure	Treatment (Eribulin Mesylate) n=15 Participants Patients receive E7389 IV on days 1 and 8. eribulin mesylate: Given IV
Stable Disease Rate, Evaluated Using RECIST Criteria	33 percentage of participants Interval 15.0 to 59.0

SECONDARY outcome

Timeframe: Up to 3 years

Estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Treatment (Eribulin Mesylate) n=15 Participants Patients receive E7389 IV on days 1 and 8. eribulin mesylate: Given IV
Median Survival Time	6 months Interval 1.0 to 21.0

SECONDARY outcome

Timeframe: At 6 months

Estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Treatment (Eribulin Mesylate) n=15 Participants Patients receive E7389 IV on days 1 and 8. eribulin mesylate: Given IV
Overall Survival	58 percentage of participants Interval 25.0 to 81.0

SECONDARY outcome

Timeframe: At 1 year

Estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Treatment (Eribulin Mesylate) n=15 Participants Patients receive E7389 IV on days 1 and 8. eribulin mesylate: Given IV
Overall Survival	0 participants

SECONDARY outcome

Timeframe: Duration of time from start of treatment until the criteria for progression are met, assessed up to 3 years

Estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Treatment (Eribulin Mesylate) n=15 Participants Patients receive E7389 IV on days 1 and 8. eribulin mesylate: Given IV
Median Time to Disease Progression	1.5 months Interval 1.0 to 9.0

SECONDARY outcome

Timeframe: At 6 months

Estimated using the Kaplan-Meier method. Median time to progression

Outcome measures

Outcome measures
Measure	Treatment (Eribulin Mesylate) n=15 Participants Patients receive E7389 IV on days 1 and 8. eribulin mesylate: Given IV
Time to Progression	1.4 months Interval 1.2 to 8.5

SECONDARY outcome

Timeframe: At 1 year

Population: Time to progression at 1 year not analyzed

Estimated using the Kaplan-Meier method.

Outcome measures

Outcome data not reported

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 3 years

Population: Data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: All patients will be evaluable for toxicity from the time of their first treatment with E7389.

Types of Gr 3 or greater adverse events that are atleast possibly related to study drug

Outcome measures

Outcome measures
Measure	Treatment (Eribulin Mesylate) n=15 Participants Patients receive E7389 IV on days 1 and 8. eribulin mesylate: Given IV
Toxicity	8 Types of adverse event

SECONDARY outcome

Timeframe: Upto 3 years

Population: Data was not collected

Objective stable disease rate Using RECIST

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Eribulin Mesylate)

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Eribulin Mesylate) n=15 participants at risk Patients receive E7389 IV on days 1 and 8. eribulin mesylate: Given IV
Skin and subcutaneous tissue disorders Dry skin	6.7% 1/15
Renal and urinary disorders Urinary tract obstruction	6.7% 1/15
Investigations Creatinine increased	6.7% 1/15
General disorders Death NOS	13.3% 2/15
Gastrointestinal disorders Constipation	6.7% 1/15

Other adverse events

Other adverse events
Measure	Treatment (Eribulin Mesylate) n=15 participants at risk Patients receive E7389 IV on days 1 and 8. eribulin mesylate: Given IV
Investigations Lymphocyte count decreased	93.3% 14/15
Gastrointestinal disorders Abdominal pain	86.7% 13/15
Blood and lymphatic system disorders Anemia	86.7% 13/15
Investigations Alkaline phosphatase increased	80.0% 12/15
General disorders Fatigue	80.0% 12/15
Gastrointestinal disorders Nausea	80.0% 12/15
Metabolism and nutrition disorders Hypoalbuminemia	73.3% 11/15
Gastrointestinal disorders Constipation	66.7% 10/15
Metabolism and nutrition disorders Hyperglycemia	66.7% 10/15
Investigations White blood cell decreased	66.7% 10/15
Investigations Alanine aminotransferase increased	60.0% 9/15
Investigations Neutrophil count decreased	60.0% 9/15

Additional Information

Dr. Malcolm Moore

Princess Margaret Cancer Centre

Phone: 416-945-2263

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60