Trial Outcomes & Findings for Lenalidomide With Gemcitabine in Treatment of Untreated Advanced Carcinoma of the Pancreas (NCT NCT00837031)
NCT ID: NCT00837031
Last Updated: 2013-03-13
Results Overview
The percentage of patients who were alive 6 months after beginning treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
6 months
Results posted on
2013-03-13
Participant Flow
Participant milestones
| Measure |
Lenalidomide/Gemcitabine
The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
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|---|---|
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Overall Study
STARTED
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72
|
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Overall Study
COMPLETED
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72
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lenalidomide With Gemcitabine in Treatment of Untreated Advanced Carcinoma of the Pancreas
Baseline characteristics by cohort
| Measure |
Lenalidomide/Gemcitabine
n=72 Participants
The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
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|---|---|
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Age Continuous
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64 years
n=5 Participants
|
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Sex: Female, Male
Female
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23 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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49 Participants
n=5 Participants
|
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Region of Enrollment
United States
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72 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 6 monthsThe percentage of patients who were alive 6 months after beginning treatment
Outcome measures
| Measure |
Lenalidomide/Gemcitabine
n=72 Participants
The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
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|---|---|
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Six-Month Overall Survival (OS) Probability, the Percentage of Patients Estimated to be Alive Six Months After Beginning Protocol Treatment
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37 percentage of participants
Interval 26.0 to 48.0
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SECONDARY outcome
Timeframe: 18 monthsThe length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease
Outcome measures
| Measure |
Lenalidomide/Gemcitabine
n=72 Participants
The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
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|---|---|
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Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease
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2.3 months
Interval 1.9 to 3.5
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SECONDARY outcome
Timeframe: 18 monthsLength of time, in months, that patients were alive from their first date of protocol treatment until death
Outcome measures
| Measure |
Lenalidomide/Gemcitabine
n=56 Participants
The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
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|---|---|
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Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
|
4.7 months
Interval 3.4 to 5.7
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Adverse Events
Lenalidomide/Gemcitabine
Serious events: 8 serious events
Other events: 71 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lenalidomide/Gemcitabine
n=72 participants at risk
The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
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|---|---|
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Metabolism and nutrition disorders
Hypokalemia
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1.4%
1/72 • Number of events 1
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|
General disorders
Weakness
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1.4%
1/72 • Number of events 1
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Renal and urinary disorders
Renal Failure
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1.4%
1/72 • Number of events 1
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|
Metabolism and nutrition disorders
Hyperbilirubinemia
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1.4%
1/72 • Number of events 1
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|
Infections and infestations
Infection - Sepsis
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1.4%
1/72 • Number of events 1
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|
Nervous system disorders
Syncope
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1.4%
1/72 • Number of events 1
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Blood and lymphatic system disorders
Hemorrhage
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1.4%
1/72 • Number of events 1
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General disorders
Death
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4.2%
3/72 • Number of events 3
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Gastrointestinal disorders
Perforation, GI
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1.4%
1/72 • Number of events 1
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|
Vascular disorders
Thrombosis/Thrombus/Embolism
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2.8%
2/72 • Number of events 2
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Cardiac disorders
Supraventricular arrhythmia - Atrial fibrillation
|
1.4%
1/72 • Number of events 1
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Blood and lymphatic system disorders
Splenic Abscess
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1.4%
1/72 • Number of events 1
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Other adverse events
| Measure |
Lenalidomide/Gemcitabine
n=72 participants at risk
The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
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|---|---|
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Metabolism and nutrition disorders
Alkaline phosphatase
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13.9%
10/72 • Number of events 16
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Metabolism and nutrition disorders
ALT
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19.4%
14/72 • Number of events 17
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Blood and lymphatic system disorders
Neutrophils
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37.5%
27/72 • Number of events 91
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Gastrointestinal disorders
Anorexia
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37.5%
27/72 • Number of events 37
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Psychiatric disorders
Anxiety
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8.3%
6/72 • Number of events 8
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Nervous system disorders
Chills
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9.7%
7/72 • Number of events 7
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Psychiatric disorders
Confusion
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9.7%
7/72 • Number of events 8
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Gastrointestinal disorders
Constipation
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34.7%
25/72 • Number of events 33
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Respiratory, thoracic and mediastinal disorders
Cough
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12.5%
9/72 • Number of events 12
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Gastrointestinal disorders
Dehydration
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18.1%
13/72 • Number of events 25
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Psychiatric disorders
Depression
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6.9%
5/72 • Number of events 5
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Gastrointestinal disorders
Diarrhea
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29.2%
21/72 • Number of events 32
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Nervous system disorders
Dizziness
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15.3%
11/72 • Number of events 15
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Respiratory, thoracic and mediastinal disorders
Dyspnea
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23.6%
17/72 • Number of events 20
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Blood and lymphatic system disorders
Edema - limb
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31.9%
23/72 • Number of events 32
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General disorders
Fatigue
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63.9%
46/72 • Number of events 88
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General disorders
Fever
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15.3%
11/72 • Number of events 18
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Blood and lymphatic system disorders
Hemoglobin
|
62.5%
45/72 • Number of events 111
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Metabolism and nutrition disorders
Hyperbilirubinemia
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12.5%
9/72 • Number of events 15
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Metabolism and nutrition disorders
Hyperglycemia
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11.1%
8/72 • Number of events 12
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|
Metabolism and nutrition disorders
Hypocalcemia
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8.3%
6/72 • Number of events 12
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|
Metabolism and nutrition disorders
Hypokalemia
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16.7%
12/72 • Number of events 24
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Metabolism and nutrition disorders
Hyponatremia
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12.5%
9/72 • Number of events 14
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Cardiac disorders
Hypotension
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11.1%
8/72 • Number of events 9
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Infections and infestations
Infection - urinary tract
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5.6%
4/72 • Number of events 4
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|
Nervous system disorders
Insomnia
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8.3%
6/72 • Number of events 9
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|
Hepatobiliary disorders
Jaundice
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6.9%
5/72 • Number of events 7
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|
Blood and lymphatic system disorders
Leukocytes
|
33.3%
24/72 • Number of events 77
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Gastrointestinal disorders
Nausea
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45.8%
33/72 • Number of events 51
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Nervous system disorders
Neuropathy - sensory
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11.1%
8/72 • Number of events 10
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|
General disorders
Pain - abdomen
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41.7%
30/72 • Number of events 46
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General disorders
Pain - back
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18.1%
13/72 • Number of events 15
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|
General disorders
Pain - chest
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16.7%
12/72 • Number of events 21
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|
General disorders
Pain - headache
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9.7%
7/72 • Number of events 9
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|
General disorders
Pain - limb
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12.5%
9/72 • Number of events 14
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|
General disorders
Pain - stomach
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6.9%
5/72 • Number of events 6
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|
Blood and lymphatic system disorders
Platelets
|
56.9%
41/72 • Number of events 147
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Skin and subcutaneous tissue disorders
Pruritis
|
5.6%
4/72 • Number of events 5
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|
Skin and subcutaneous tissue disorders
Rash
|
30.6%
22/72 • Number of events 33
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|
Gastrointestinal disorders
Taste alteration
|
8.3%
6/72 • Number of events 7
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|
Vascular disorders
Thrombus/thrombosis/embolism
|
27.8%
20/72 • Number of events 27
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|
Nervous system disorders
Tremor
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5.6%
4/72 • Number of events 5
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|
Gastrointestinal disorders
Vomiting
|
20.8%
15/72 • Number of events 21
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|
General disorders
Weakness
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15.3%
11/72 • Number of events 21
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|
General disorders
Weight loss
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15.3%
11/72 • Number of events 17
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
- Publication restrictions are in place
Restriction type: OTHER