Trial Outcomes & Findings for Recombinant Human Hyaluronidase in Treating Lymphedema in Patients With Cancer (NCT NCT01928030)
NCT ID: NCT01928030
Last Updated: 2017-03-21
Results Overview
Reported as any untoward medical occurrence or worsening of a pre-existing medical condition in a participant administered recombinant human hyaluronidase, and judged possibly, probably, or definitely related to treatment
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
3 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2017-03-21
Participant Flow
Participant milestones
| Measure |
450 Units rHuPH20 (Days 1, 3, 5, and 7)
Patients receive 450 units rHuPH20 SC on days 1, 3, 5, and 7
|
900 Units rHuPH20 (Days 1, 3, 5, and 7)
Patients receive 900 units rHuPH20 SC on days 1, 3, 5, and 7
|
MTD rHuPH20 (Days 1 to 21)
Days 1 to 21 Patients receive the maximum tolerated dose (MTD) of rHuPH20 SC on days 1 to 21.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
0
|
|
Overall Study
COMPLETED
|
3
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Recombinant Human Hyaluronidase in Treating Lymphedema in Patients With Cancer
Baseline characteristics by cohort
| Measure |
Hyaluronidase, Recombinant Human
n=3 Participants
Patients receive recombinant human hyaluronidase 450 units or 900 units SC on days 1, 3, 5, and 7 (Phase 1) and then on days 1 to 21 (Phase 2) 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
|
2 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
56 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearReported as any untoward medical occurrence or worsening of a pre-existing medical condition in a participant administered recombinant human hyaluronidase, and judged possibly, probably, or definitely related to treatment
Outcome measures
| Measure |
450 Units Recombinant Human Hyaluronidase (rHuPH20)
n=3 Participants
Participants receive 450 units recombinant human hyaluronidase (rHuPH20) subcutaneously (SC) on Days 1, 3, 5, and 7 (Phase 1) and then on Days 1 to 21 (Phase 2) in the absence of disease progression or unacceptable toxicity.
|
900 Units rHuPH20 (Days 1, 3, 5, and 7)
Patients receive 900 units rHuPH20 SC on days 1, 3, 5, and 7
|
MTD rHuPH20 (Days 1 to 21)
Days 1 to 21 Patients receive the maximum tolerated dose (MTD) of rHuPH20 SC on days 1 to 21.
|
|---|---|---|---|
|
Treatment-related Adverse Events
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: No participants received 900 units rHuPH20, and the MTD was not determined, so no participants received rHuPH20 at the MTD.
Number of patients that achieve a clinically significant reduction in lymphedema, assessed as a 20% reduction in excess forearm volume
Outcome measures
| Measure |
450 Units Recombinant Human Hyaluronidase (rHuPH20)
n=3 Participants
Participants receive 450 units recombinant human hyaluronidase (rHuPH20) subcutaneously (SC) on Days 1, 3, 5, and 7 (Phase 1) and then on Days 1 to 21 (Phase 2) in the absence of disease progression or unacceptable toxicity.
|
900 Units rHuPH20 (Days 1, 3, 5, and 7)
Patients receive 900 units rHuPH20 SC on days 1, 3, 5, and 7
|
MTD rHuPH20 (Days 1 to 21)
Days 1 to 21 Patients receive the maximum tolerated dose (MTD) of rHuPH20 SC on days 1 to 21.
|
|---|---|---|---|
|
Reduction in Forearm Volume
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Recombinant Human Hyaluronidase
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Recombinant Human Hyaluronidase
n=3 participants at risk
Participants who received 450 units recombinant human hyaluronidase (rHuPH20) subcutaneously in Phase 1 were assessed in this outcome measure, treatment-related adverse events.
Biomarker analysis and pharmacology study were performed during study.
recombinant human hyaluronidase: Given subcutaneously
|
|---|---|
|
Skin and subcutaneous tissue disorders
Erythema (injection site reaction)
|
33.3%
1/3 • Number of events 1
|
Additional Information
Dr. Mark Pegram, Susy Yuan-Huey Hung Professor
Stanford University
Phone: 650-723-5801
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place