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RAD001 Plus Carboplatin in Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT01127763
Recruitment Status : Completed
First Posted : May 21, 2010
Results First Posted : April 9, 2014
Last Update Posted : April 9, 2014
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
New York University School of Medicine

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: RAD001
Drug: Carboplatin
Enrollment 25
Recruitment Details From June 2010 to July 2012, 25 patients were enrolled from New York University Medical center and its affiliated hospitals.
Pre-assignment Details  
Arm/Group Title RAD001+Carboplatin
Hide Arm/Group Description Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 25
Completed 20 [1]
Not Completed 5
Reason Not Completed
Adverse Event             2
Withdrawal by Subject             1
Physician Decision             2
[1]
Patients off study due to disease progression were considered to have completed the study.
Arm/Group Title RAD001+Carboplatin
Hide Arm/Group Description Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
<=18 years
0
   0.0%
Between 18 and 65 years
19
  76.0%
>=65 years
6
  24.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 25 participants
58
(32 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
25
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
Number of prior chemotherapy regimens  
Median (Full Range)
Unit of measure:  Chemotherapy regimens
Number Analyzed 25 participants
1
(0 to 3)
1.Primary Outcome
Title Clinical Benefit Rate (Complete Response, Partial Response, and Stable Disease That Lasts More Than 6 Months)
Hide Description Clinical benefit rate is defined as the number of patients with complete response (CR), partial response (PR), or stable disease (SD) that lasts at least 6 months. Response was assessed every 2 cycles of treatment (6 weeks) by computed tomography (CT), CT/positron emission tomography (PET), or magnetic resonance imaging (MRI). Overall response evaluation is based on Response Evaluation Criteria In Solid Tumors 1.0 (RECIST 1.0). Per RECIST 1.0 for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Time Frame up to 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Any patient with at least one dose of treatment.
Arm/Group Title RAD001+Carboplatin
Hide Arm/Group Description:

Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.

RAD001

Carboplatin

Overall Number of Participants Analyzed 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
36
(21 to 57)
2.Primary Outcome
Title Toxicity Profile-Hematological
Hide Description Reported as percentage of patients who experienced grade 3 and higher hematological adverse events (AEs) related to the study drugs.
Time Frame treatment period (up to 1 year) plus 30 days off treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
any patient who received at least 1 dose of protocol treatment.
Arm/Group Title RAD001+Carboplatin (AUC 6 and 5) RAD001+Carboplatin (AUC 4) RAD001+Carboplatin (All Patients)
Hide Arm/Group Description:
Carboplatin (starting dose of AUC 6 or AUC 5) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day.
Carboplatin (starting dose of AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day.
Carboplatin every 3 weeks as IV infusion and RAD001 as 5 mg pill each day.
Overall Number of Participants Analyzed 7 18 25
Measure Type: Number
Unit of Measure: percentage of patients
Anemia 0 5 4
Thrombocytopenia 71 11 28
Leukopenia 14 0 4
Neutropenia 29 5 12
3.Primary Outcome
Title Toxicity Profile-Non Hematological
Hide Description Reported as percentage of patients who experienced grade 3 and higher non-hematological AEs related to the study drugs.
Time Frame treatment period (up to 1 year) plus 30 days off treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
any patient who received at least 1 dose of protocol treatment.
Arm/Group Title RAD001+Carboplatin (All Patients)
Hide Arm/Group Description:
Carboplatin every 3 weeks as IV infusion and RAD001 as 5 mg pill each day.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: percentage of patients
Nausea 4
Vomiting 4
Dehydration 4
Mucositis 4
Hypersensitivity 4
4.Secondary Outcome
Title Median Progression-free Survival Time
Hide Description Progression-free survival time is defined as the time from first day of treatment to the first date of disease progression or death as a result of any cause. Progression was assessed every 2 cycles of treatment (6 weeks) by CT, CT/PET, or MRI. Progression is defined using RECIST 1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame up to 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Any patient with at least one dose of treatment.
Arm/Group Title RAD001+Carboplatin
Hide Arm/Group Description:

Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.

RAD001

Carboplatin

Overall Number of Participants Analyzed 25
Median (95% Confidence Interval)
Unit of Measure: months
3
(2 to 5)
Time Frame AEs were assessed during the treatment and 30 days from the last day of treatment.
Adverse Event Reporting Description All AEs are reported here regardless of attribution.
 
Arm/Group Title RAD001+Carboplatin
Hide Arm/Group Description Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.
All-Cause Mortality
RAD001+Carboplatin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
RAD001+Carboplatin
Affected / at Risk (%)
Total   5/25 (20.00%) 
Cardiac disorders   
Hypertension  1  1/25 (4.00%) 
Gastrointestinal disorders   
Dehydration  1  1/25 (4.00%) 
Infections and infestations   
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils  1  2/25 (8.00%) 
Nervous system disorders   
Pain  1  1/25 (4.00%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea (Shortness Of Breath)  1  2/25 (8.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
RAD001+Carboplatin
Affected / at Risk (%)
Total   25/25 (100.00%) 
Blood and lymphatic system disorders   
Hemolysis (E.G., Immune Hemolytic Anemia, Drug-Related Hemolysis)  1  9/25 (36.00%) 
Dermal Change Lymphedema, Phlebolymphedema  1  2/25 (8.00%) 
Edema: Head And Neck  1  1/25 (4.00%) 
Edema: Limb  1  4/25 (16.00%) 
Endocrine disorders   
Hot Flashes/Flushes  1  1/25 (4.00%) 
Eye disorders   
Dry Eye Syndrome  1  1/25 (4.00%) 
Gastrointestinal disorders   
Anorexia  1  3/25 (12.00%) 
Constipation  1  6/25 (24.00%) 
Diarrhea  1  2/25 (8.00%) 
Dry Mouth/Salivary Gland (Xerostomia)  1  1/25 (4.00%) 
Mucositis/Stomatitis (Functional/Symptomatic)  1  2/25 (8.00%) 
Nausea  1  11/25 (44.00%) 
Taste Alteration (Dysgeusia)  1  2/25 (8.00%) 
Vomiting  1  7/25 (28.00%) 
Pain_stomach  1  1/25 (4.00%) 
General disorders   
Fatigue (Asthenia, Lethargy, Malaise)  1  11/25 (44.00%) 
Fever (In The Absence Of Neutropenia, Where Neutropenia Is Defined As Anc <1.0 X 10e9/L)  1  3/25 (12.00%) 
Immune system disorders   
Allergic Reaction/Hypersensitivity (Including Drug Fever)  1  1/25 (4.00%) 
Infections and infestations   
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils  1  2/25 (8.00%) 
Injury, poisoning and procedural complications   
Bruising (In Absence Of Grade 3 Or 4 Thrombocytopenia)  1  1/25 (4.00%) 
Pain - Other (Specify, incisional pain)  1  1/25 (4.00%) 
Investigations   
Leukocytes (Total Wbc)  1  4/25 (16.00%) 
Neutrophils/Granulocytes (Anc/Agc)  1  11/25 (44.00%) 
Platelets  1  16/25 (64.00%) 
Inr (International Normalized Ratio Of Prothrombin Time)  1  1/25 (4.00%) 
Cholesterol, Serum-High (Hypercholestremia)  1  1/25 (4.00%) 
Metabolism and nutrition disorders   
Alkaline Phosphatase  1  3/25 (12.00%) 
Alt, Sgpt (Serum Glutamic Pyruvic Transaminase)  1  3/25 (12.00%) 
Ast, Sgot(Serum Glutamic Oxaloacetic Transaminase)  1  2/25 (8.00%) 
Proteinuria  1  1/25 (4.00%) 
Musculoskeletal and connective tissue disorders   
Extremity-Lower (Gait/Walking)  1  1/25 (4.00%) 
Muscle Weakness, Generalized Or Specific Area (Not Due To Neuropathy)  1  2/25 (8.00%) 
Pain_extremity-limb  1  3/25 (12.00%) 
Pain_joint  1  1/25 (4.00%) 
Pain_back  1  4/25 (16.00%) 
Pain_bone  1  1/25 (4.00%) 
Nervous system disorders   
Dizziness  1  4/25 (16.00%) 
Mood Alteration  1  1/25 (4.00%) 
Neuropathy: Sensory  1  3/25 (12.00%) 
Pain_headache  1  4/25 (16.00%) 
Psychiatric disorders   
Insomnia  1  1/25 (4.00%) 
Reproductive system and breast disorders   
Vaginal Discharge (Non-Infectious)  1  1/25 (4.00%) 
Pain_breast  1  2/25 (8.00%) 
Respiratory, thoracic and mediastinal disorders   
Hemorrhage, Pulmonary/Upper Respiratory  1  3/25 (12.00%) 
Cough  1  2/25 (8.00%) 
Dyspnea (Shortness Of Breath)  1  3/25 (12.00%) 
Nasal Cavity/Paranasal Sinus Reactions  1  1/25 (4.00%) 
Voice Changes/Dysarthria (E.G., Hoarseness, Loss Or Alteration In Voice, Laryngitis)  1  1/25 (4.00%) 
Skin and subcutaneous tissue disorders   
Dermatology/Skin - Other (Specify, skin nodules  1  1/25 (4.00%) 
Pruritus/Itching  1  1/25 (4.00%) 
Rash/Desquamation  1  4/25 (16.00%) 
Rash: Acne/Acneiform  1  4/25 (16.00%) 
Vascular disorders   
Flushing  1  1/25 (4.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Amy Tiersten, MD
Organization: Mt Sinai School of Medicine
Phone: 212-249-3300
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01127763     History of Changes
Other Study ID Numbers: NYU 09-0060
First Submitted: May 19, 2010
First Posted: May 21, 2010
Results First Submitted: January 24, 2014
Results First Posted: April 9, 2014
Last Update Posted: April 9, 2014