Trial Outcomes & Findings for Everolimus Combined With Anti-estrogen Therapy in Hormone-Receptor-Positive HER-2 Negative Advanced Breast Cancer (NCT NCT02291913)

NCT ID: NCT02291913

Last Updated: 2020-02-17

Results Overview

PFS is defined as the time from Day 1 of study drug administration to disease progression as defined by RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1 criteria, or death on study. Participants who are alive and free from disease progression will be censored at the date of last radiologic tumor assessment. Participants who receive non-protocol therapy (subsequent therapy) prior to incurring an event will be censored at the date of last tumor assessment prior to the start of subsequent therapy. Participants who do not have a post-baseline tumor assessment will be censored at the date of first treatment (Day 1).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

48 participants

Primary outcome timeframe

up to 3 years

Results posted on

2020-02-17

Participant Flow

Between December 2014 to December 2015, 48 patients who had locally recurrent or metastatic breast cancer with cytologically or histologically confirmed hormone receptor-positive breast cancer who have demonstrated disease progression on prior anti-estrogen therapy. Study was closed after enrollment goal was reached.

Participant milestones

Participant milestones
Measure	Everolimus Everolimus will be administered at a dose of 10 mg PO daily combined with any one of the following anti-estrogen therapies on which the patient most recently progressed (tamoxifen, fulvestrant, anastrozole, letrozole, exemestane, toremifine, or LHRH agonists in conjunction with anti-estrogen therapy). Anti-estrogen therapy will be administered at the US Food and Drug Administration (FDA) prescribed doses. Everolimus Exemestane: Anti-estrogen therapy Tamoxifen: Anti-estrogen therapy Fulvestrant: Anti-estrogen therapy Anastrozole: Anti-estrogen therapy Letrozole: Anti-estrogen therapy Toremifine: Anti-estrogen therapy
Overall Study STARTED	48
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	48

Reasons for withdrawal

Reasons for withdrawal
Measure	Everolimus Everolimus will be administered at a dose of 10 mg PO daily combined with any one of the following anti-estrogen therapies on which the patient most recently progressed (tamoxifen, fulvestrant, anastrozole, letrozole, exemestane, toremifine, or LHRH agonists in conjunction with anti-estrogen therapy). Anti-estrogen therapy will be administered at the US Food and Drug Administration (FDA) prescribed doses. Everolimus Exemestane: Anti-estrogen therapy Tamoxifen: Anti-estrogen therapy Fulvestrant: Anti-estrogen therapy Anastrozole: Anti-estrogen therapy Letrozole: Anti-estrogen therapy Toremifine: Anti-estrogen therapy
Overall Study Progressive Disease	32
Overall Study Adverse Event	11
Overall Study Death	2
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	1
Overall Study Protocol Violation	1

Baseline Characteristics

Everolimus Combined With Anti-estrogen Therapy in Hormone-Receptor-Positive HER-2 Negative Advanced Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Everolimus n=48 Participants Everolimus will be administered at a dose of 10 mg by mouth daily combined with any one of the following anti-estrogen therapies on which the patient most recently progressed (tamoxifen, fulvestrant, anastrozole, letrozole, exemestane, toremifine, or LHRH agonists in conjunction with anti-estrogen therapy). Anti-estrogen therapy will be administered at the US Food and Drug Administration (FDA) prescribed doses. A treatment cycle was defined as 4 weeks, with radiological evaluations every 8 weeks. Everolimus Exemestane: Anti-estrogen therapy Tamoxifen: Anti-estrogen therapy Fulvestrant: Anti-estrogen therapy Anastrozole: Anti-estrogen therapy Letrozole: Anti-estrogen therapy Toremifine: Anti-estrogen therapy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	40 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	48 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 3 years

Population: Participants who received at least 1 cycle of study treatment and had at least one post-baseline radiologic assessment were evaluable for PFS analysis per protocol. 36 of the total 48 patients were analyzed for PFS. The remaining 12 treated patients did not meet this criteria to be analyzed.

Outcome measures

Outcome measures
Measure	Everolimus n=36 Participants Everolimus will be administered at a dose of 10 mg PO daily combined with any one of the following anti-estrogen therapies on which the patient most recently progressed (tamoxifen, fulvestrant, anastrozole, letrozole, exemestane, toremifine, or LHRH agonists in conjunction with anti-estrogen therapy). Anti-estrogen therapy will be administered at the US Food and Drug Administration (FDA) prescribed doses. Everolimus Exemestane: Anti-estrogen therapy Tamoxifen: Anti-estrogen therapy Fulvestrant: Anti-estrogen therapy Anastrozole: Anti-estrogen therapy Letrozole: Anti-estrogen therapy Toremifine: Anti-estrogen therapy
Median Progression Free Survival (PFS)	7.2 months Interval 4.1 to 10.0

SECONDARY outcome

Timeframe: Up to 20 months

Population: Number of participants who received at least one dose of study drug.

Assessments were made through analysis of the reported incidence of treatment-emergent AEs. All participants who received at least one dose of protocol treatment were followed for safety. Adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Outcome measures

Outcome measures
Measure	Everolimus n=48 Participants Everolimus will be administered at a dose of 10 mg PO daily combined with any one of the following anti-estrogen therapies on which the patient most recently progressed (tamoxifen, fulvestrant, anastrozole, letrozole, exemestane, toremifine, or LHRH agonists in conjunction with anti-estrogen therapy). Anti-estrogen therapy will be administered at the US Food and Drug Administration (FDA) prescribed doses. Everolimus Exemestane: Anti-estrogen therapy Tamoxifen: Anti-estrogen therapy Fulvestrant: Anti-estrogen therapy Anastrozole: Anti-estrogen therapy Letrozole: Anti-estrogen therapy Toremifine: Anti-estrogen therapy
Number of Patients With Adverse Events (AEs) as a Measure of Safety and Tolerability	48 Participants

SECONDARY outcome

Timeframe: every 8 weeks until discontinuation, up to 20 months

Population: Participants who received at least 1 cycle of study treatment and had at least one post-baseline radiologic assessment. 36 of the total 48 patients were analyzed for PFS. The remaining 12 treated patients did not meet this criteria to be analyzed.

Defined as the number of patients with objective evidence of complete or partial response (CR or PR) using RECIST version 1.1. A CR is the complete disappearance of all target lesions. A PR is a decrease of 30% or more of the diameter(s) of all target lesions from the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	Everolimus n=36 Participants Everolimus will be administered at a dose of 10 mg PO daily combined with any one of the following anti-estrogen therapies on which the patient most recently progressed (tamoxifen, fulvestrant, anastrozole, letrozole, exemestane, toremifine, or LHRH agonists in conjunction with anti-estrogen therapy). Anti-estrogen therapy will be administered at the US Food and Drug Administration (FDA) prescribed doses. Everolimus Exemestane: Anti-estrogen therapy Tamoxifen: Anti-estrogen therapy Fulvestrant: Anti-estrogen therapy Anastrozole: Anti-estrogen therapy Letrozole: Anti-estrogen therapy Toremifine: Anti-estrogen therapy
Number of Patients With an Objective Response (CR or PR) Also Called the Overall Response Rate (ORR).	2 Participants

SECONDARY outcome

Timeframe: Up to 20 months

The proportion of patients with Complete Response (CR) or Partial Response (PR) or 6 months or more of Stable Disease (SD). A CR is the complete disappearance of all target lesions. A PR is a decrease of 30% or more of the diameter(s) of all target lesions from the baseline sum of diameters. SD is not meeting the criteria for PR or a 20% increase in target lesions called Progressive Disease (PD).

Outcome measures

Outcome measures
Measure	Everolimus n=36 Participants Everolimus will be administered at a dose of 10 mg PO daily combined with any one of the following anti-estrogen therapies on which the patient most recently progressed (tamoxifen, fulvestrant, anastrozole, letrozole, exemestane, toremifine, or LHRH agonists in conjunction with anti-estrogen therapy). Anti-estrogen therapy will be administered at the US Food and Drug Administration (FDA) prescribed doses. Everolimus Exemestane: Anti-estrogen therapy Tamoxifen: Anti-estrogen therapy Fulvestrant: Anti-estrogen therapy Anastrozole: Anti-estrogen therapy Letrozole: Anti-estrogen therapy Toremifine: Anti-estrogen therapy
Number of Participants With CR, PR, or 6 Months of SD Also Called Clinical Benefit Rate (CBR)	12 Participants

SECONDARY outcome

Timeframe: every 8 weeks until discontinuation, up to 20 months

Population: Only those patients who achieved Complete Response or Partial Response will be included in the summaries of DOR. A CR is the complete disappearance of all target lesions. A PR is a decrease of 30% or more of the diameter(s) of all target lesions from the baseline sum of diameters.

Only those patients who achieved Complete Response or Partial Response will be included in the summaries of DOR. DOR is defined as time from first date of response of CR or PR to disease progression or death as defined by RECIST v1.1 criteria. Participants who are alive and free from disease progression will be censored at the date of last tumor assessment. Patients who receive non-protocol therapy (subsequent therapy) prior to incurring an event will be censored at the date of last tumor assessment prior to the start of subsequent therapy. A CR is the complete disappearance of all target lesions. A PR is a decrease of 30% or more of the diameter(s) of all target lesions from the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	Everolimus n=2 Participants Everolimus will be administered at a dose of 10 mg PO daily combined with any one of the following anti-estrogen therapies on which the patient most recently progressed (tamoxifen, fulvestrant, anastrozole, letrozole, exemestane, toremifine, or LHRH agonists in conjunction with anti-estrogen therapy). Anti-estrogen therapy will be administered at the US Food and Drug Administration (FDA) prescribed doses. Everolimus Exemestane: Anti-estrogen therapy Tamoxifen: Anti-estrogen therapy Fulvestrant: Anti-estrogen therapy Anastrozole: Anti-estrogen therapy Letrozole: Anti-estrogen therapy Toremifine: Anti-estrogen therapy
Median Time From First Occurrence of CR or PR to Disease Progression or Death Also Called Duration of Response (DOR)	8.8 months Interval 1.8 to 11.8

SECONDARY outcome

Timeframe: up to 3 years from first treatment

Population: Participants who received at least 1 cycle of study treatment and had at least one post-baseline radiologic assessment were evaluable for OS analysis per protocol. 36 of the total 48 patients were analyzed for OS. The remaining 12 treated patients did not meet this criteria to be analyzed.

Defined as the time from date of first study treatment to date of death due to any cause. Patients who are alive will be censored at the date of last known date alive.

Outcome measures

Outcome measures
Measure	Everolimus n=36 Participants Everolimus will be administered at a dose of 10 mg PO daily combined with any one of the following anti-estrogen therapies on which the patient most recently progressed (tamoxifen, fulvestrant, anastrozole, letrozole, exemestane, toremifine, or LHRH agonists in conjunction with anti-estrogen therapy). Anti-estrogen therapy will be administered at the US Food and Drug Administration (FDA) prescribed doses. Everolimus Exemestane: Anti-estrogen therapy Tamoxifen: Anti-estrogen therapy Fulvestrant: Anti-estrogen therapy Anastrozole: Anti-estrogen therapy Letrozole: Anti-estrogen therapy Toremifine: Anti-estrogen therapy
Median Overall Survival (OS)	26.7 months Interval 16.3 to 26.7

Adverse Events

Everolimus

Serious events: 15 serious events

Other events: 48 other events

Deaths: 32 deaths

Serious adverse events

Serious adverse events
Measure	Everolimus n=48 participants at risk Everolimus will be administered at a dose of 10 mg PO daily combined with any one of the following anti-estrogen therapies on which the patient most recently progressed (tamoxifen, fulvestrant, anastrozole, letrozole, exemestane, toremifine, or LHRH agonists in conjunction with anti-estrogen therapy). Anti-estrogen therapy will be administered at the US Food and Drug Administration (FDA) prescribed doses. Everolimus Exemestane: Anti-estrogen therapy Tamoxifen: Anti-estrogen therapy Fulvestrant: Anti-estrogen therapy Anastrozole: Anti-estrogen therapy Letrozole: Anti-estrogen therapy Toremifine: Anti-estrogen therapy
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	2.1% 1/48 • Number of events 1 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.1% 1/48 • Number of events 1 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Blood and lymphatic system disorders Anemia	2.1% 1/48 • Number of events 1 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Cardiac disorders Cardiac failure congestive	2.1% 1/48 • Number of events 1 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Constipation	4.2% 2/48 • Number of events 2 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Esophagitis	2.1% 1/48 • Number of events 1 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Gastrointestinal hemorrhage	2.1% 1/48 • Number of events 1 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Non-Cardiac chest pain	2.1% 1/48 • Number of events 1 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Pain	2.1% 1/48 • Number of events 2 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Hepatobiliary disorders Cholecystitis	2.1% 1/48 • Number of events 1 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Diverticulitis	2.1% 1/48 • Number of events 1 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Cellulitis	2.1% 1/48 • Number of events 1 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Gastroenteritis	2.1% 1/48 • Number of events 1 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Sepsis	2.1% 1/48 • Number of events 1 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Dehydration	2.1% 1/48 • Number of events 1 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	2.1% 1/48 • Number of events 1 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.1% 1/48 • Number of events 1 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.1% 1/48 • Number of events 1 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Vascular disorders Embolism	2.1% 1/48 • Number of events 1 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Other adverse events

Other adverse events
Measure	Everolimus n=48 participants at risk Everolimus will be administered at a dose of 10 mg PO daily combined with any one of the following anti-estrogen therapies on which the patient most recently progressed (tamoxifen, fulvestrant, anastrozole, letrozole, exemestane, toremifine, or LHRH agonists in conjunction with anti-estrogen therapy). Anti-estrogen therapy will be administered at the US Food and Drug Administration (FDA) prescribed doses. Everolimus Exemestane: Anti-estrogen therapy Tamoxifen: Anti-estrogen therapy Fulvestrant: Anti-estrogen therapy Anastrozole: Anti-estrogen therapy Letrozole: Anti-estrogen therapy Toremifine: Anti-estrogen therapy
General disorders Fatigue	64.6% 31/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Nausea	37.5% 18/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Stomatitis	31.2% 15/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Rash	31.2% 15/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Mucosal Inflammation	27.1% 13/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Dyspnoea	27.1% 13/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Diarrhoea	25.0% 12/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Headache	22.9% 11/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Vomiting	20.8% 10/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Urinary Tract Infection	18.8% 9/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Cough	18.8% 9/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Blood and lymphatic system disorders Anaemia	16.7% 8/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Decreased Appetite	14.6% 7/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Musculoskeletal and connective tissue disorders Back Pain	14.6% 7/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	14.6% 7/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Psychiatric disorders Insomnia	14.6% 7/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Oedema Peripheral	14.6% 7/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Blood and lymphatic system disorders Thrombocytopenia	10.4% 5/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Constipation	10.4% 5/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Aspartate Aminotransferase Increased	10.4% 5/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Hyperglycaemia	10.4% 5/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Epistaxis	10.4% 5/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Respiratory, thoracic and mediastinal disorders Pneumonitis	10.4% 5/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Blood and lymphatic system disorders Neutropenia	8.3% 4/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Musculoskeletal and connective tissue disorders Arthralgia	8.3% 4/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Nervous system disorders Dizziness	8.3% 4/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Abdominal Pain	6.2% 3/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Dry Mouth	6.2% 3/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Gastrointestinal disorders Haemorrhoids	6.2% 3/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
General disorders Pyrexia	6.2% 3/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Cellulitis	6.2% 3/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Infections and infestations Sinusitis	6.2% 3/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Alanine Aminotransferase Increased	6.2% 3/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Investigations Weight Decreased	6.2% 3/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Metabolism and nutrition disorders Dehydration	6.2% 3/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Musculoskeletal and connective tissue disorders Muscle Spasms	6.2% 3/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Psychiatric disorders Depression	6.2% 3/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Skin and subcutaneous tissue disorders Rash Pruritic	6.2% 3/48 • Up to 20 months All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Additional Information

Senior Director, Regulatory Science

Sarah Cannon Development Innovations

Phone: 844-710-6157

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60