Trial Outcomes & Findings for SJG-136 in Treating Patients With Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer That Did Not Respond to Previous Treatment With Cisplatin or Carboplatin (NCT NCT01200797)
NCT ID: NCT01200797
Last Updated: 2015-05-25
Results Overview
Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), \>=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), \>=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR\>PR\>SD\>PD. Confirmation of CR or PR is required to deem either one the best overall response.
TERMINATED
PHASE2
19 participants
On-treatment date to date of disease progression (assessed up to 12 months)
2015-05-25
Participant Flow
The study opened to accrual in July 2010, with participants enrolled from 11/1/2010 through 8/30/2012. Five Southeast Phase 2 Consortium (SEP2C) cancer center sites participated in this study.
Twenty-two patients consented to this study. Three were not eligible to receive treatment.
Participant milestones
| Measure |
Treatment (SJG-136)
SJG-136 was administered consecutively on days 1 - 3 as a 20-minute intravenous infusion, at a dose of 30 mcg/m2/day. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Treatment (SJG-136)
SJG-136 was administered consecutively on days 1 - 3 as a 20-minute intravenous infusion, at a dose of 30 mcg/m2/day. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
symptomatic deterioration
|
2
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Disease Progression
|
13
|
Baseline Characteristics
SJG-136 in Treating Patients With Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer That Did Not Respond to Previous Treatment With Cisplatin or Carboplatin
Baseline characteristics by cohort
| Measure |
Treatment (SJG-136)
n=19 Participants
Patients receive SJG-136 IV over 20 minutes on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
60.57895 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: On-treatment date to date of disease progression (assessed up to 12 months)Population: All patients with best overall response data; patients are excluded if best overall response data is missing or if the patient is nonevaluable for best overall response
Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), \>=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), \>=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR\>PR\>SD\>PD. Confirmation of CR or PR is required to deem either one the best overall response.
Outcome measures
| Measure |
Treatment (SJG-136)
n=17 Participants
Patients receive 30 mcg/m2 of SJG-136 intravenously, over a period of 20 minutes, on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Response (OR)
Number of patients with complete response
|
0 participants
|
|
Overall Response (OR)
Number of patients with partial response
|
0 participants
|
|
Overall Response (OR)
Number of patients with stable disease
|
6 participants
|
|
Overall Response (OR)
Number of patients with progressive disease
|
11 participants
|
|
Overall Response (OR)
Number of patients not evaluable
|
2 participants
|
PRIMARY outcome
Timeframe: On-study date to 30 days following final dose of studyPopulation: Total number of patients reported with any toxicity. Not all participants may have an adverse event, thus not every patient on-treatment may be accounted for in worst-grade toxicities.
Count of patients according to the worst-grade toxicity experienced by each, where worst-grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life-threatening; grade 5, death.
Outcome measures
| Measure |
Treatment (SJG-136)
n=18 Participants
Patients receive 30 mcg/m2 of SJG-136 intravenously, over a period of 20 minutes, on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Patients With Each Worst-grade Toxicity
Number of patients with worst-grade toxicity 5
|
0 participants
|
|
Number of Patients With Each Worst-grade Toxicity
Number of patients with worst-grade toxicity 1
|
5 participants
|
|
Number of Patients With Each Worst-grade Toxicity
Number of patients with worst-grade toxicity 2
|
8 participants
|
|
Number of Patients With Each Worst-grade Toxicity
Number of patients with worst-grade toxicity 3
|
4 participants
|
|
Number of Patients With Each Worst-grade Toxicity
Number of patients with worst-grade toxicity 4
|
1 participants
|
PRIMARY outcome
Timeframe: On-study date to lesser of date of progression or date of (assessed up to 12 months)Population: All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where either death or progression is an event, with censoring for non-progressed, non-expired patients at greater of off-study date or last known alive date.
Estimated probable duration of life without disease progression, from on-study date to earlier of progression date or date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as \>=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.
Outcome measures
| Measure |
Treatment (SJG-136)
n=19 Participants
Patients receive 30 mcg/m2 of SJG-136 intravenously, over a period of 20 minutes, on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Progression-free Survival (PFS)
|
49 days
Interval 44.0 to 79.0
|
PRIMARY outcome
Timeframe: On-study date to date of death from any cause (assessed up to 12 months)Population: All patients are included in the analysis on intention-to treat basis. Analysis is by Kaplan-Meier method, where death is an event, with censoring for non-expired patients at greater of off-study date or last known alive date.
Estimated probable duration of life from on-study date to date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details).
Outcome measures
| Measure |
Treatment (SJG-136)
n=19 Participants
Patients receive 30 mcg/m2 of SJG-136 intravenously, over a period of 20 minutes, on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival (OS)
|
271 daya
Interval 145.0 to 371.0
|
PRIMARY outcome
Timeframe: On-study date to date of progression (assessed up to 12 months)Population: All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where progression is an event, with censoring for non-progressed patients at greater of off-study date, last known alive date, or date of death not attributable to disease progression.
Estimated probable duration from on-study date to date of disease progression, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as \>=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.
Outcome measures
| Measure |
Treatment (SJG-136)
n=19 Participants
Patients receive 30 mcg/m2 of SJG-136 intravenously, over a period of 20 minutes, on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Time to Progression (TTP)
|
49 days
Interval 44.0 to 129.0
|
Adverse Events
Treatment (SJG-136)
Serious adverse events
| Measure |
Treatment (SJG-136)
n=19 participants at risk
Patients receive SJG-136 IV over 20 minutes on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Cardiac disorders
Heart failure
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain - Grade 2
|
10.5%
2/19 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain - Grade 3
|
10.5%
2/19 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Colonic obstruction
|
10.5%
2/19 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Ileus
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Nausea - Grade 2
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Nausea - Grade 3
|
10.5%
2/19 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Vomiting - Grade 1
|
5.3%
1/19 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Vomiting - Grade 2
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Vomiting - Grade 3
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
General disorders
Edema limbs
|
10.5%
2/19 • Number of events 2 • 2 years
|
|
General disorders
Edema trunk
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
General disorders
Fatigue
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
General disorders
General disorders and administration site conditions - other
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
General disorders
Pain
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Infections and infestations
Urinary tract infection
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Injury - other (car crash)
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Investigations
Alkaline phosphatase increased
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Investigations
Creatinine increased
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Investigations
Weight gain
|
5.3%
1/19 • Number of events 2 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Anxiety
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea - Grade 2
|
10.5%
2/19 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea - Grade 3
|
10.5%
2/19 • Number of events 4 • 2 years
|
|
Vascular disorders
Capillary leak syndrome
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Vascular disorders
Hypotension
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
General disorders
Death NOS
|
5.3%
1/19 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Treatment (SJG-136)
n=19 participants at risk
Patients receive SJG-136 IV over 20 minutes on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
General disorders
Fatigue
|
47.4%
9/19 • Number of events 11 • 2 years
|
|
General disorders
Edema limbs
|
36.8%
7/19 • Number of events 8 • 2 years
|
|
General disorders
Pain
|
15.8%
3/19 • Number of events 5 • 2 years
|
|
General disorders
General disorders and administration site conditions - other
|
10.5%
2/19 • Number of events 2 • 2 years
|
|
General disorders
Edema face
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
General disorders
Edema trunk
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
26.3%
5/19 • Number of events 10 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
21.1%
4/19 • Number of events 5 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
21.1%
4/19 • Number of events 5 • 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
15.8%
3/19 • Number of events 4 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
15.8%
3/19 • Number of events 4 • 2 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - other
|
15.8%
3/19 • Number of events 5 • 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.5%
2/19 • Number of events 2 • 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.5%
2/19 • Number of events 2 • 2 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
52.6%
10/19 • Number of events 12 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
42.1%
8/19 • Number of events 11 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
36.8%
7/19 • Number of events 9 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
31.6%
6/19 • Number of events 9 • 2 years
|
|
Gastrointestinal disorders
Ascites
|
10.5%
2/19 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
10.5%
2/19 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Colonic obstruction
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Stomach pain
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Investigations
Weight gain
|
26.3%
5/19 • Number of events 7 • 2 years
|
|
Investigations
Lymphocyte count decreased
|
21.1%
4/19 • Number of events 7 • 2 years
|
|
Investigations
Alkaline phosphatase increased
|
10.5%
2/19 • Number of events 3 • 2 years
|
|
Investigations
Creatinine increased
|
10.5%
2/19 • Number of events 2 • 2 years
|
|
Investigations
Investigations - other
|
5.3%
1/19 • Number of events 2 • 2 years
|
|
Investigations
Lymphocyte count increased
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Investigations
Platelet count decreased
|
5.3%
1/19 • Number of events 2 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
15.8%
3/19 • Number of events 3 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.5%
2/19 • Number of events 3 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.5%
2/19 • Number of events 2 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - other
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
42.1%
8/19 • Number of events 12 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.8%
3/19 • Number of events 3 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - other
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
36.8%
7/19 • Number of events 10 • 2 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - other
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Nervous system disorders
Dizziness
|
10.5%
2/19 • Number of events 3 • 2 years
|
|
Nervous system disorders
Dysgeusia
|
10.5%
2/19 • Number of events 2 • 2 years
|
|
Nervous system disorders
Headache
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Nervous system disorders
Memory impairment
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Nervous system disorders
Nervous system disorders - other
|
5.3%
1/19 • Number of events 2 • 2 years
|
|
Nervous system disorders
Parethesia
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Vascular disorders
Capillary leak syndrome
|
10.5%
2/19 • Number of events 3 • 2 years
|
|
Vascular disorders
Hypertension
|
10.5%
2/19 • Number of events 2 • 2 years
|
|
Vascular disorders
Hypotension
|
5.3%
1/19 • Number of events 2 • 2 years
|
|
Vascular disorders
Phlebitis
|
5.3%
1/19 • Number of events 2 • 2 years
|
|
Vascular disorders
Vascular disorders - other
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Infections and infestations
Urinary tract infection
|
15.8%
3/19 • Number of events 3 • 2 years
|
|
Infections and infestations
Vaginal infection
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Renal and urinary disorders - other
|
10.5%
2/19 • Number of events 2 • 2 years
|
|
Renal and urinary disorders
Urinary tract pain
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Urinary urgency
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Eye disorders
Blurred vision
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Eye disorders
Eye disorders - other
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benigh, malignant and unspecified (incl cysts and polyps) - other
|
10.5%
2/19 • Number of events 2 • 2 years
|
|
Psychiatric disorders
Insomnia
|
10.5%
2/19 • Number of events 3 • 2 years
|
|
Psychiatric disorders
Anxiety
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Restlessness
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - other
|
10.5%
2/19 • Number of events 2 • 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
5.3%
1/19 • Number of events 1 • 2 years
|
|
Reproductive system and breast disorders
Premature menopause
|
5.3%
1/19 • Number of events 1 • 2 years
|
Additional Information
Marta A. Crispens, M.D.
Vanderbilt-Ingram Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60