Trial Outcomes & Findings for Phosphatidylinositol 3 Kinase and Mammalian Target of Rapamycin (PI3K-mTOR) in Advanced Cancer Patients (NCT NCT00877773)
NCT ID: NCT00877773
Last Updated: 2016-08-25
Results Overview
For solid tumors, initial responses defined by Response Evaluation Criteria in Solid (RECIST) criteria in the evaluable lesion(s) per Complete Response (CR): Disappearance of all target lesions; confirmed at 4 weeks; Partial Response (PR): At least 30% decrease; confirmed at 4 weeks; Stable Disease (SD): Neither PR nor PD criteria met; Progressive Disease (PD): 20% increase; no CR, PR or SD documented before increased disease, or new lesion(s).
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
44 participants
Primary outcome timeframe
Baseline to Disease Progression (restaged at 8 weeks and at 4 months)
Results posted on
2016-08-25
Participant Flow
Recruitment Period: April 6, 2009 to March 28, 2013. All recruitment done at The University of Texas MD Anderson Cancer Center.
Participant milestones
| Measure |
Temsirolimus
Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
44
|
Reasons for withdrawal
| Measure |
Temsirolimus
Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
|
|---|---|
|
Overall Study
Disease Progression
|
44
|
Baseline Characteristics
Phosphatidylinositol 3 Kinase and Mammalian Target of Rapamycin (PI3K-mTOR) in Advanced Cancer Patients
Baseline characteristics by cohort
| Measure |
Temsirolimus
n=44 Participants
Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
|
|---|---|
|
Age, Continuous
|
57 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline to Disease Progression (restaged at 8 weeks and at 4 months)Population: Of the 44 participants enrolled, only 30 were evaluable for response.
For solid tumors, initial responses defined by Response Evaluation Criteria in Solid (RECIST) criteria in the evaluable lesion(s) per Complete Response (CR): Disappearance of all target lesions; confirmed at 4 weeks; Partial Response (PR): At least 30% decrease; confirmed at 4 weeks; Stable Disease (SD): Neither PR nor PD criteria met; Progressive Disease (PD): 20% increase; no CR, PR or SD documented before increased disease, or new lesion(s).
Outcome measures
| Measure |
Temsirolimus
n=30 Participants
Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
|
|---|---|
|
Tumor Response
Complete Response (CR)
|
0 participants
|
|
Tumor Response
Partial Response (PR)
|
2 participants
|
|
Tumor Response
Stable Disease
|
20 participants
|
|
Tumor Response
Progressive Disease (PD)
|
8 participants
|
Adverse Events
Temsirolimus
Serious events: 6 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Temsirolimus
n=44 participants at risk
Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
|
|---|---|
|
Infections and infestations
Symptomatic Hydrocephalous
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
General disorders
Weakness
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
Nervous system disorders
Headaches
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
Nervous system disorders
Syncopal Episode
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
General disorders
Cachexia
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Ventilatory Respiratory Failure
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
Other adverse events
| Measure |
Temsirolimus
n=44 participants at risk
Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.1%
4/44 • Number of events 4 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
Infections and infestations
Neutropenia
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
9.1%
4/44 • Number of events 4 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
Cardiac disorders
Hypotension
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
Gastrointestinal disorders
Tongue Swelling
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
Renal and urinary disorders
Acute Renal Insufficiency
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
General disorders
Pain
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
Blood and lymphatic system disorders
Increased Swelling of the Face
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
Gastrointestinal disorders
Nausea
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
Gastrointestinal disorders
Partial Small Bowel Obstruction
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
Nervous system disorders
Aphasia
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
General disorders
Right-Sided Upper Extremity Weakness
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
Renal and urinary disorders
Acute Renal Failure
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
Gastrointestinal disorders
Increased Ascites
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
Nervous system disorders
Syncopal Episode
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
General disorders
Unbalanced
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Metastasis
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
General disorders
Fever
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
|
Vascular disorders
Epitaxis
|
2.3%
1/44 • Number of events 1 • Adverse event collection through 2 cycles (about 8 weeks) of treatment.
|
Additional Information
Daniel Karp, MD / Professor, Investigational Cancer Therapeutics
University of Texas (UT) MD Anderson Cancer Center
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place