Trial Outcomes & Findings for Temsirolimus and Cixutumumab in Treating Patients With Locally Advanced, Metastatic, or Recurrent Soft Tissue Sarcoma or Bone Sarcoma (NCT NCT01016015)
NCT ID: NCT01016015
Last Updated: 2015-07-30
Results Overview
From study entry until recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurement recorded on study), death or date of last contact, assessed at 12 weeks
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
178 participants
Primary outcome timeframe
From study entry until recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurement recorded on study), death or date of last contact, assessed at 12 weeks
Results posted on
2015-07-30
Participant Flow
Participant milestones
| Measure |
Cixutumumab and Temsirolimus
Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
178
|
|
Overall Study
COMPLETED
|
159
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Cixutumumab and Temsirolimus
Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Not Treated
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
15
|
Baseline Characteristics
Temsirolimus and Cixutumumab in Treating Patients With Locally Advanced, Metastatic, or Recurrent Soft Tissue Sarcoma or Bone Sarcoma
Baseline characteristics by cohort
| Measure |
Cixutumumab and Temsirolimus
n=178 Participants
Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
144 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
178 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From study entry until recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurement recorded on study), death or date of last contact, assessed at 12 weeksFrom study entry until recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurement recorded on study), death or date of last contact, assessed at 12 weeks
Outcome measures
| Measure |
Cixutumumab and Temsirolimus
n=159 Participants
Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Progression-free Survival Rate, Defined as CR + PR + SD, as Assessed by RECIST Criteria
Partial Response
|
4 participants
|
|
Progression-free Survival Rate, Defined as CR + PR + SD, as Assessed by RECIST Criteria
Progression of Disease
|
57 participants
|
|
Progression-free Survival Rate, Defined as CR + PR + SD, as Assessed by RECIST Criteria
Stable Disease
|
98 participants
|
Adverse Events
Cixutumumab and Temsirolimus
Serious events: 83 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cixutumumab and Temsirolimus
n=175 participants at risk
Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.9%
5/175 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.7%
3/175 • Number of events 3
|
|
Gastrointestinal disorders
Proctitis
|
0.57%
1/175 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.57%
1/175 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash maculo papular
|
0.57%
1/175 • Number of events 1
|
|
Renal and urinary disorders
Renal and urinary disorder
|
1.7%
3/175 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic & mediastinal disorder Other, spec
|
0.57%
1/175 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
0.57%
1/175 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.57%
1/175 • Number of events 2
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.57%
1/175 • Number of events 1
|
|
Surgical and medical procedures
Surgical and medical procedures
|
0.57%
1/175 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.57%
1/175 • Number of events 1
|
|
Vascular disorders
Thromboembolic event
|
1.7%
3/175 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
2.3%
4/175 • Number of events 7
|
|
Gastrointestinal disorders
Vomiting
|
0.57%
1/175 • Number of events 1
|
|
Investigations
White blood cell decreased
|
4.0%
7/175 • Number of events 10
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
3/175 • Number of events 6
|
|
Investigations
Alanine aminotransferase increased
|
1.1%
2/175 • Number of events 2
|
|
Investigations
Alkaline phosphatase increased
|
0.57%
1/175 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
2.3%
4/175 • Number of events 4
|
|
Metabolism and nutrition disorders
Anorexia
|
0.57%
1/175 • Number of events 1
|
|
Gastrointestinal disorders
Ascites
|
0.57%
1/175 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
1.1%
2/175 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.57%
1/175 • Number of events 1
|
|
Blood and lymphatic system disorders
Blood and lymph system disorder
|
0.57%
1/175 • Number of events 1
|
|
Investigations
Blood Bilirubin increase
|
0.57%
1/175 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.57%
1/175 • Number of events 1
|
|
Cardiac disorders
Cardiac arrest
|
0.57%
1/175 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
0.57%
1/175 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
1.7%
3/175 • Number of events 3
|
|
Gastrointestinal disorders
Colonic fistula
|
0.57%
1/175 • Number of events 1
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.57%
1/175 • Number of events 1
|
|
Gastrointestinal disorders
Colonic perforation
|
0.57%
1/175 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
0.57%
1/175 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
2/175 • Number of events 2
|
|
General disorders
Death NOS
|
6.3%
11/175 • Number of events 11
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
5/175 • Number of events 5
|
|
Gastrointestinal disorders
Diarrhea
|
5.1%
9/175 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.4%
6/175 • Number of events 7
|
|
General disorders
Edema-Limb
|
0.57%
1/175 • Number of events 1
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.57%
1/175 • Number of events 1
|
|
Eye disorders
Eye disorder
|
0.57%
1/175 • Number of events 1
|
|
General disorders
Fatigue
|
0.57%
1/175 • Number of events 1
|
|
General disorders
Fever
|
1.7%
3/175 • Number of events 3
|
|
Injury, poisoning and procedural complications
Fracture
|
1.1%
2/175 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.57%
1/175 • Number of events 1
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.57%
1/175 • Number of events 1
|
|
Hepatobiliary disorders
Hepatobiliary disorder
|
1.1%
2/175 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.1%
2/175 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
2.3%
4/175 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.1%
2/175 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.1%
2/175 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.57%
1/175 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.1%
2/175 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.0%
7/175 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.57%
1/175 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypotension
|
0.57%
1/175 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.1%
2/175 • Number of events 2
|
|
Infections and infestations
Infection and Infestations
|
1.7%
3/175 • Number of events 3
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.57%
1/175 • Number of events 2
|
|
General disorders
Localized edema
|
0.57%
1/175 • Number of events 1
|
|
Infections and infestations
Lung Infection
|
4.0%
7/175 • Number of events 8
|
|
Investigations
Lymphocyte count decrease
|
0.57%
1/175 • Number of events 1
|
|
Infections and infestations
Mucosal infection
|
1.1%
2/175 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis-Oral
|
6.9%
12/175 • Number of events 14
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limbs
|
0.57%
1/175 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.57%
1/175 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
3.4%
6/175 • Number of events 8
|
|
General disorders
Non-cardiac chest pain
|
0.57%
1/175 • Number of events 1
|
|
General disorders
Pain
|
2.9%
5/175 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.1%
2/175 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.57%
1/175 • Number of events 1
|
|
Infections and infestations
Paronychia
|
1.1%
2/175 • Number of events 2
|
|
Cardiac disorders
Pericardial effusion
|
1.1%
2/175 • Number of events 2
|
|
Investigations
Platelet count decreased
|
5.7%
10/175 • Number of events 10
|
Other adverse events
| Measure |
Cixutumumab and Temsirolimus
n=175 participants at risk
Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Investigations
Activated partial thromboplastin time prolonged
|
8.0%
14/175 • Number of events 25
|
|
Investigations
Alanine aminotransferase
|
18.3%
32/175 • Number of events 60
|
|
Investigations
Alkaline phosphatase increased
|
18.3%
32/175 • Number of events 175
|
|
Investigations
Aspartate aminotransferase increased
|
17.7%
31/175 • Number of events 132
|
|
Investigations
Blood Bilirubin increased
|
6.9%
12/175 • Number of events 29
|
|
Investigations
Cholesterol, High
|
23.4%
41/175 • Number of events 139
|
|
Investigations
Creatinine increased
|
10.9%
19/175 • Number of events 192
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
34.9%
61/175 • Number of events 915
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.6%
8/175 • Number of events 21
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
22.9%
40/175 • Number of events 159
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
29.1%
51/175 • Number of events 509
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.9%
26/175 • Number of events 157
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.6%
15/175 • Number of events 57
|
|
Investigations
Hyponatremia
|
17.1%
30/175 • Number of events 133
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.9%
19/175 • Number of events 52
|
|
Metabolism and nutrition disorders
INR increased
|
17.7%
31/175 • Number of events 107
|
|
Investigations
Lymphocyte count decrease
|
10.3%
18/175 • Number of events 98
|
|
Investigations
Neutrophil count decrease
|
12.0%
21/175 • Number of events 59
|
|
Investigations
Platelet Count decrease
|
28.6%
50/175 • Number of events 404
|
|
Investigations
White blood cell decrease
|
25.1%
44/175 • Number of events 285
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60