Trial Outcomes & Findings for Ph II Atrasentan + DOXIL in Recurrent Ovarian/Fallopian/Peritoneal Serous Papillary Adenocarcinoma (NCT NCT00653328)
NCT ID: NCT00653328
Last Updated: 2012-05-23
Results Overview
Tumor progression is determined by appropriate imaging techniques according to RECIST criteria or by CA-125 serum level \>=2x baseline and \>=70 IU/ml, confirmed by a second determination at least 28 days after the first determination
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Date on study to the date of measured progressive disease, every 2 cycles (2 months)
Results posted on
2012-05-23
Participant Flow
Recruitment period = 5/28/2003 through 9/15/2006
A total of 16 people signed consent to take part in this study; of those, one withdrew consent before beginning treatment.
Participant milestones
| Measure |
Altrasentan + Doxil
Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Altrasentan + Doxil
Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Disease progression
|
10
|
|
Overall Study
Drug manufacturer no longing making drug
|
2
|
Baseline Characteristics
Ph II Atrasentan + DOXIL in Recurrent Ovarian/Fallopian/Peritoneal Serous Papillary Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Altrasentan + Doxil
n=15 Participants
Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age Continuous
|
66 years
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Date on study to the date of measured progressive disease, every 2 cycles (2 months)Population: Patients available for measurement of tumor response. One patient withdrew after beginning treatment.
Tumor progression is determined by appropriate imaging techniques according to RECIST criteria or by CA-125 serum level \>=2x baseline and \>=70 IU/ml, confirmed by a second determination at least 28 days after the first determination
Outcome measures
| Measure |
Altrasentan + Doxil
n=14 Participants
Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
|
|---|---|
|
Median Time to Tumor Progression
|
1 Months
Full Range 2.9 • Interval 0.0 to 11.0
|
SECONDARY outcome
Timeframe: At month 2 and monthly thereafter to cessation of treatmentPopulation: Patients who were available for measurement of tumor response.One patient withdrew after beginning treatment and was not available for measurement.
Patient response to treatment: Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started, or appearance of \>= 1 new lesions, and/or 2x CA-125 levels to \>=70 IU/ml, confirmed by second measurement after 28 days Complete response (CR): disappearance of all target lesions Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD
Outcome measures
| Measure |
Altrasentan + Doxil
n=14 Participants
Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
|
|---|---|
|
Number of Patients With Objective Response
Complete Response
|
0 participants
|
|
Number of Patients With Objective Response
Partial Response
|
0 participants
|
|
Number of Patients With Objective Response
Stable Disease
|
3 participants
|
|
Number of Patients With Objective Response
Progressive Disease
|
11 participants
|
SECONDARY outcome
Timeframe: Date on study to date of death from any causePopulation: All patients who received treatment. Two patients alive at last follow-up.
Outcome measures
| Measure |
Altrasentan + Doxil
n=13 Participants
Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
|
|---|---|
|
Overall Survival
|
10 Months
Interval 1.0 to 33.0
|
SECONDARY outcome
Timeframe: Weekly for 2 weeks, then monthly for 5 monthsNot all participants necessarily have an adverse event, thus not everyone will be accounted for in worst-grade toxicities. Likewise, one participant can potentially have more than one event in various grades 1-5 which accounts for the difference in number of patients analyzed and total number in the worst-grade toxicity tables. Tables represent the number of patients with worst-grade toxicity at each of five grades (grade 1, least severe; to grade 5, most severe) following NCI Common Toxicity Criteria
Outcome measures
| Measure |
Altrasentan + Doxil
n=15 Participants
Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
|
|---|---|
|
Number of Patients With Worst Grade Toxicities
Number of participants with worst grade toxicity 1
|
5 participants
|
|
Number of Patients With Worst Grade Toxicities
Number of participants with worst grade toxicity 2
|
3 participants
|
|
Number of Patients With Worst Grade Toxicities
Number of participants with worst grade toxicity 3
|
3 participants
|
|
Number of Patients With Worst Grade Toxicities
Number of participants with worst grade toxicity 4
|
0 participants
|
|
Number of Patients With Worst Grade Toxicities
Number of participants with worst grade toxicity 5
|
0 participants
|
Adverse Events
Altrasentan + Doxil
Serious events: 5 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Altrasentan + Doxil
n=15 participants at risk
Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
|
|---|---|
|
Cardiac disorders
Pericardial effusion
|
6.7%
1/15 • Number of events 1
|
|
Vascular disorders
Thromboembolism
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Fatigue
|
20.0%
3/15 • Number of events 5
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.3%
2/15 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
1/15 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
13.3%
2/15 • Number of events 2
|
|
General disorders
Death
|
6.7%
1/15 • Number of events 1
|
|
General disorders
edema
|
6.7%
1/15 • Number of events 2
|
|
General disorders
fever
|
13.3%
2/15 • Number of events 2
|
|
General disorders
fatigue
|
13.3%
2/15 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.7%
1/15 • Number of events 2
|
|
Reproductive system and breast disorders
pelvic pain
|
6.7%
1/15 • Number of events 1
|
|
Renal and urinary disorders
urinary frequency
|
6.7%
1/15 • Number of events 1
|
|
Investigations
hemoglobin
|
13.3%
2/15 • Number of events 2
|
|
Gastrointestinal disorders
abdominal cramping
|
6.7%
1/15 • Number of events 1
|
|
Vascular disorders
hot flashes
|
6.7%
1/15 • Number of events 1
|
Other adverse events
| Measure |
Altrasentan + Doxil
n=15 participants at risk
Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
46.7%
7/15 • Number of events 50
|
|
General disorders
fatigue
|
66.7%
10/15 • Number of events 34
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypoalbuminemia
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.7%
1/15 • Number of events 2
|
|
Reproductive system and breast disorders
pelvic pain
|
13.3%
2/15 • Number of events 2
|
|
Renal and urinary disorders
Urinary urgency
|
6.7%
1/15 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
33.3%
5/15 • Number of events 8
|
|
Gastrointestinal disorders
Vomiting
|
26.7%
4/15 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal Pain
|
26.7%
4/15 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
53.3%
8/15 • Number of events 11
|
|
Vascular disorders
Hot flashes
|
13.3%
2/15 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
20.0%
3/15 • Number of events 5
|
|
Blood and lymphatic system disorders
Leukocytes
|
26.7%
4/15 • Number of events 29
|
|
Investigations
neutrophils, granulocytes
|
13.3%
2/15 • Number of events 25
|
|
Investigations
platelets
|
6.7%
1/15 • Number of events 14
|
|
Cardiac disorders
arrhythmias
|
6.7%
1/15 • Number of events 1
|
|
General disorders
edema
|
53.3%
8/15 • Number of events 13
|
|
Vascular disorders
hypotension
|
13.3%
2/15 • Number of events 2
|
|
General disorders
fever
|
13.3%
2/15 • Number of events 2
|
|
General disorders
rigors, chills
|
6.7%
1/15 • Number of events 1
|
|
Vascular disorders
sweating
|
6.7%
1/15 • Number of events 1
|
|
Investigations
weight gain
|
26.7%
4/15 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
alopecia
|
26.7%
4/15 • Number of events 11
|
|
Injury, poisoning and procedural complications
bruising
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
rash
|
20.0%
3/15 • Number of events 8
|
|
Infections and infestations
infectious wound
|
6.7%
1/15 • Number of events 2
|
|
Endocrine disorders
endrocrine
|
6.7%
1/15 • Number of events 1
|
|
Psychiatric disorders
anorexia
|
13.3%
2/15 • Number of events 3
|
|
Gastrointestinal disorders
constipation
|
40.0%
6/15 • Number of events 8
|
|
Gastrointestinal disorders
dehydration
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
diarrhea
|
13.3%
2/15 • Number of events 2
|
|
Gastrointestinal disorders
dysphagia
|
13.3%
2/15 • Number of events 2
|
|
Gastrointestinal disorders
GI other
|
46.7%
7/15 • Number of events 12
|
|
Gastrointestinal disorders
mouth dryness
|
6.7%
1/15 • Number of events 1
|
|
General disorders
hemorrhage
|
6.7%
1/15 • Number of events 1
|
|
Investigations
alkaline phosphatase
|
13.3%
2/15 • Number of events 2
|
|
Hepatobiliary disorders
SGOT
|
13.3%
2/15 • Number of events 5
|
|
Hepatobiliary disorders
SGPT
|
13.3%
2/15 • Number of events 3
|
|
Infections and infestations
infection without neutropenia
|
13.3%
2/15 • Number of events 2
|
|
Metabolism and nutrition disorders
hyperglycemia
|
33.3%
5/15 • Number of events 11
|
|
Metabolism and nutrition disorders
hypocalcemia
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
hypokalemia
|
6.7%
1/15 • Number of events 2
|
|
Metabolism and nutrition disorders
metabolic, other
|
20.0%
3/15 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
arthritis
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
dizziness
|
6.7%
1/15 • Number of events 1
|
|
Psychiatric disorders
insomnia
|
20.0%
3/15 • Number of events 7
|
|
Psychiatric disorders
mood alteration
|
26.7%
4/15 • Number of events 6
|
|
Nervous system disorders
neuropathy
|
46.7%
7/15 • Number of events 12
|
|
Eye disorders
dry eye
|
13.3%
2/15 • Number of events 3
|
|
Eye disorders
tearing
|
6.7%
1/15 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
6.7%
1/15 • Number of events 2
|
|
Nervous system disorders
headache
|
26.7%
4/15 • Number of events 7
|
|
Cardiac disorders
chest pain
|
6.7%
1/15 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
6.7%
1/15 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
pleuritic pain
|
6.7%
1/15 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
tumor pain
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
26.7%
4/15 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary, other
|
13.3%
2/15 • Number of events 2
|
|
Investigations
creatinine
|
13.3%
2/15 • Number of events 2
|
|
Renal and urinary disorders
dysuria
|
13.3%
2/15 • Number of events 2
|
|
Renal and urinary disorders
Renal, other
|
13.3%
2/15 • Number of events 2
|
|
General disorders
constitutional symptoms
|
6.7%
1/15 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
pain
|
13.3%
2/15 • Number of events 5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place