Trial Outcomes & Findings for Ziv-aflibercept in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gynecologic Soft Tissue Sarcoma (NCT NCT00390234)
NCT ID: NCT00390234
Last Updated: 2015-12-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2015-12-07
Participant Flow
Participant milestones
| Measure |
Treatment (Ziv-aflibercept)
Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
63
|
|
Overall Study
COMPLETED
|
63
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ziv-aflibercept in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gynecologic Soft Tissue Sarcoma
Baseline characteristics by cohort
| Measure |
Treatment (Ziv-aflibercept)
n=63 Participants
Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsOutcome measures
| Measure |
Treatment (Ziv-aflibercept)
n=63 Participants
Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Objective Response Rate, Evaluated According to the RECIST Criteria
|
0 participants
|
PRIMARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Treatment (Ziv-aflibercept)
n=40 Participants
Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Leiomyosaroma Group)
|
0.17 months
Interval 0.06 to 0.32
|
PRIMARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Treatment (Ziv-aflibercept)
n=22 Participants
Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Carcinosarcoma Group)
|
1.6 months
Interval 1.1 to 1.7
|
SECONDARY outcome
Timeframe: Up to 3 yearsSurvival statistics will be estimated using the Kaplan-Meier method. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. 95% confidence intervals will be provided for estimates of interest where possible.
Outcome measures
| Measure |
Treatment (Ziv-aflibercept)
n=40 Participants
Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Survival (Leiomyosarcoma Group)
|
18.1 months
Interval 8.5 to
Value not reached
|
SECONDARY outcome
Timeframe: Up to 3 yearsSurvival statistics will be estimated using the Kaplan-Meier method. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. 95% confidence intervals will be provided for estimates of interest where possible.
Outcome measures
| Measure |
Treatment (Ziv-aflibercept)
n=22 Participants
Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Survival (Carcinosarcoma Group)
|
3.2 months
Interval 1.4 to
Value not reached
|
Adverse Events
Treatment (Ziv-aflibercept)
Serious events: 29 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Ziv-aflibercept)
n=63 participants at risk
Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.2%
2/63
|
|
General disorders
Non-cardiac chest pain
|
1.6%
1/63
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.2%
2/63
|
|
Investigations
Creatinine increased
|
1.6%
1/63
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.6%
1/63
|
|
Metabolism and nutrition disorders
Dehydration
|
6.3%
4/63
|
|
General disorders
Death NOS
|
6.3%
4/63
|
|
Vascular disorders
Hypotension
|
1.6%
1/63
|
|
Eye disorders
Extraocular muscle paresis
|
1.6%
1/63
|
|
Infections and infestations
Infections and infestations - Other, specify
|
3.2%
2/63
|
|
Vascular disorders
Hypertension
|
9.5%
6/63
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.6%
1/63
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.6%
1/63
|
|
General disorders
Edema limbs
|
1.6%
1/63
|
|
Nervous system disorders
Headache
|
3.2%
2/63
|
|
Nervous system disorders
Intracranial hemorrhage
|
3.2%
2/63
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
4.8%
3/63
|
|
Renal and urinary disorders
Acute kidney injury
|
3.2%
2/63
|
|
Investigations
Lymphocyte count decreased
|
1.6%
1/63
|
|
Renal and urinary disorders
Proteinuria
|
1.6%
1/63
|
|
Gastrointestinal disorders
Small intestinal perforation
|
1.6%
1/63
|
|
Nervous system disorders
Reversible posterior leukoencephalopathy syndrome
|
1.6%
1/63
|
|
Gastrointestinal disorders
Abdominal pain
|
9.5%
6/63
|
|
Investigations
Alanine aminotransferase increased
|
1.6%
1/63
|
|
Infections and infestations
Urinary tract infection
|
1.6%
1/63
|
|
General disorders
Fatigue
|
1.6%
1/63
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
3/63
|
|
Gastrointestinal disorders
Abdominal distension
|
1.6%
1/63
|
|
Gastrointestinal disorders
Constipation
|
4.8%
3/63
|
|
Gastrointestinal disorders
Nausea
|
3.2%
2/63
|
|
Eye disorders
Vitreous hemorrhage
|
3.2%
2/63
|
|
Gastrointestinal disorders
Anorexia
|
1.6%
1/63
|
|
Nervous system disorders
Cognitive disturbance
|
1.6%
1/63
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
2/63
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.6%
1/63
|
|
Renal and urinary disorders
Urinary tract pain
|
1.6%
1/63
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.6%
1/63
|
Other adverse events
| Measure |
Treatment (Ziv-aflibercept)
n=63 participants at risk
Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
ziv-aflibercept: Given IV
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
General disorders
Fatigue
|
74.6%
47/63
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60