Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Everolimus and OSI-906 for Patients With Refractory Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01154335
Recruitment Status : Completed
First Posted : June 30, 2010
Results First Posted : January 14, 2015
Last Update Posted : January 14, 2015
Sponsor:
Collaborators:
Novartis Pharmaceuticals
OSI Pharmaceuticals
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Colorectal Cancer
Interventions Drug: OSI-906
Drug: Everolimus
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dose Level 1 Dose Level 2 Dose Level 2a
Hide Arm/Group Description

combination of OSI-906 and everolimus

OSI-906: 50 mg Twice a Day, cycle-28 days

Everolimus: 5mg Daily, cycle-28 days

combination of OSI-906 and everolimus

OSI-906: 100 mg Twice a Day, cycle-28 days

Everolimus: 10mg Daily, cycle-28 days

combination of OSI-906 and everolimus

OSI-906: 100 mg Twice a Day, cycle-28 days

Everolimus: 5mg Daily, cycle-28 days

Period Title: Overall Study
Started 7 6 5
Completed 0 [1] 0 [1] 0 [1]
Not Completed 7 6 5
[1]
Patients continued treatment until disease progression or unacceptable toxicity occurred.
Arm/Group Title Dose Level 1 Dose Level 2 Dose Level 2a Total
Hide Arm/Group Description

combination of OSI-906 and everolimus

OSI-906: 50 mg Twice a Day, cycle-28 days

Everolimus: 5mg Daily, cycle-28 days

combination of OSI-906 and everolimus

OSI-906: 100 mg Twice a Day, cycle-28 days

Everolimus: 10mg Daily, cycle-28 days

combination of OSI-906 and everolimus

OSI-906: 100 mg Twice a Day, cycle-28 days

Everolimus: 5mg Daily, cycle-28 days

Total of all reporting groups
Overall Number of Baseline Participants 7 6 5 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 7 participants 6 participants 5 participants 18 participants
55
(47 to 73)
54
(51 to 76)
70
(44 to 76)
55
(44 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 5 participants 18 participants
Female
4
  57.1%
4
  66.7%
1
  20.0%
9
  50.0%
Male
3
  42.9%
2
  33.3%
4
  80.0%
9
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 6 participants 5 participants 18 participants
7 6 5 18
1.Primary Outcome
Title To Determine the Maximum Tolerated Dose (MTD) of the Combination of OSI-906 and Everolimus for the Treatment of Patients With Refractory Metastatic Colorectal Cancer.
Hide Description [Not Specified]
Time Frame 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
Determination of the MTD consists of the selection of one of the three dose levels as the maximum tolerated dose. This outcome is the same for all patients.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: milligrams
OSI-906 BID Dose 50
Everolimus QD Dose 5
2.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description Progression-free survival (PFS) is defined as the time between Day 1 Cycle 1 and date of first documented recurrence or death. Patients who do not exhibit progression while on trial will be censored at their last known assessment. Progression is defined per RECIST criteria as either 1) at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest (nadir) sum since the treatment started, or the appearance of one or more new lesions. Requires not only 20% increase, but absolute increase of a minimum of 5 mm over sum. OR 2) Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Time Frame 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
Progression-Free Survival was determined only as a preliminary indication of efficacy and was calculated for all patients at all dose levels
Overall Number of Participants Analyzed 18
Median (95% Confidence Interval)
Unit of Measure: weeks
8
(7 to 9)
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival (OS) is defined as the time between Day 1 Cycle 1 to the date of death from any cause. Those remaining alive will be censored at their last known assessment or follow-up.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
Overall Survival was determined only as a preliminary indication of efficacy and was calculated for all patients at all dose levels
Overall Number of Participants Analyzed 18
Median (95% Confidence Interval)
Unit of Measure: weeks
30.6
(16.7 to 32.1)
4.Secondary Outcome
Title Response Rate
Hide Description Response rate (RR) will be estimated as the proportion of patients exhibiting complete response or partial response out of all evaluable cases. Complete Response is defined per RECIST as disappearance of all target/non-target lesions and normalization of tumor markers. Partial Response is defined per RECIST as At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients who received at least 8 weeks of treatment were considered evaluable for response and were included in the response rate analysis
Arm/Group Title All Patients
Hide Arm/Group Description:
Response Rate was determined only as a preliminary indication of efficacy and was calculated for all patients at all dose levels
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Patients
Hide Arm/Group Description Adverse Event data was was calculated for all patients at all dose levels
All-Cause Mortality
All Patients
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
All Patients
Affected / at Risk (%)
Total   6/18 (33.33%) 
Gastrointestinal disorders   
Gastrointestinal disorders - Other, esophageal spasm  1  1/18 (5.56%) 
Gastrointestinal disorders - Other, mechanical bowel obstruction  1  1/18 (5.56%) 
General disorders   
General disorders and administration site conditions - Other, disease progression  1  1/18 (5.56%) 
Investigations   
Platelet count decreased  1  1/18 (5.56%) 
Respiratory, thoracic and mediastinal disorders   
Respiratory failure  1  1/18 (5.56%) 
Pleural effusion  1  1/18 (5.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Patients
Affected / at Risk (%)
Total   18/18 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1  5/18 (27.78%) 
Gastrointestinal disorders   
Diarrhea  1  7/18 (38.89%) 
Nausea  1  7/18 (38.89%) 
Constipation  1  5/18 (27.78%) 
Mucositis  1  5/18 (27.78%) 
Vomiting  1  4/18 (22.22%) 
Oral pain  1  2/18 (11.11%) 
Anal pain  1  1/18 (5.56%) 
Dry mouth  1  1/18 (5.56%) 
Gastrointestinal pain  1  1/18 (5.56%) 
General disorders   
Fatigue  1  8/18 (44.44%) 
Pain  1  3/18 (16.67%) 
Edema face  1  1/18 (5.56%) 
Edema limbs  1  1/18 (5.56%) 
General disorders and administration site conditions - Other, hemorrhage  1  1/18 (5.56%) 
Non-cardiac chest pain  1  1/18 (5.56%) 
Infections and infestations   
Sinusitis  1  1/18 (5.56%) 
Urinary tract infection  1  1/18 (5.56%) 
Injury, poisoning and procedural complications   
Injury, poisoning and procedural complications - Other, laceration  1  1/18 (5.56%) 
Investigations   
Neutrophil count decreased  1  2/18 (11.11%) 
Platelet count decreased  1  2/18 (11.11%) 
Weight loss  1  2/18 (11.11%) 
Alanine aminotransferase increased  1  1/18 (5.56%) 
Aspartate aminotransferase increased  1  1/18 (5.56%) 
Blood bilirubin increased  1  1/18 (5.56%) 
Creatinine increased  1  1/18 (5.56%) 
Metabolism and nutrition disorders   
Anorexia  1  8/18 (44.44%) 
Dehydration  1  2/18 (11.11%) 
Hypokalemia  1  1/18 (5.56%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  3/18 (16.67%) 
Myalgia  1  2/18 (11.11%) 
Generalized muscle weakness  1  1/18 (5.56%) 
Neck pain  1  1/18 (5.56%) 
Nervous system disorders   
Peripheral sensory neuropathy  1  2/18 (11.11%) 
Dizziness  1  1/18 (5.56%) 
Headache  1  1/18 (5.56%) 
Tremor  1  1/18 (5.56%) 
Psychiatric disorders   
Depression  1  1/18 (5.56%) 
Insomnia  1  1/18 (5.56%) 
Renal and urinary disorders   
Renal and urinary disorders - Other, dysuria  1  1/18 (5.56%) 
Urinary retention  1  1/18 (5.56%) 
Urinary tract pain  1  1/18 (5.56%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  4/18 (22.22%) 
Dyspnea  1  3/18 (16.67%) 
Nasal congestion  1  3/18 (16.67%) 
Aspiration  1  1/18 (5.56%) 
Respiratory, thoracic and mediastinal disorders - Other, runny nose  1  1/18 (5.56%) 
Sore throat  1  1/18 (5.56%) 
Skin and subcutaneous tissue disorders   
Rash  1  3/18 (16.67%) 
Pruritus  1  1/18 (5.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The sponsor can review/embargo results communications prior to public release for a period that is >60 but =180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John D Hainsworth, MD
Organization: Sarah Cannon Research Institute
Phone: 1-877-691-7274
EMail: asksarah@scresearch.net
Layout table for additonal information
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT01154335    
Other Study ID Numbers: SCRI GI 124
First Submitted: June 29, 2010
First Posted: June 30, 2010
Results First Submitted: January 6, 2015
Results First Posted: January 14, 2015
Last Update Posted: January 14, 2015