Trial Outcomes & Findings for Carboplatin and ABI-007 in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery (NCT NCT00404235)

Last Updated: 2018-10-16

Results Overview

The RECIST criteria will be used for response assessments. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. The tumor response rate is defined as the total number of eligible patients who achieved a complete or partial response according to the RECIST criteria divided by the total number of eligible patients enrolled on study. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

76 participants

Primary outcome timeframe

Up to 2 years

Results posted on

2018-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1 (Prior Chemotherapy, PT) Patients with malignant melanoma who have received prior chemotherapy for their metastatic disease receive 100 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.	Cohort 2 (Chemotherapy Naive, CN) For patients with malignant melanoma who have not received prior chemotherapy for their metastatic disease, patients receive 100 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	35	41
Overall Study COMPLETED	34	39
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 (Prior Chemotherapy, PT) Patients with malignant melanoma who have received prior chemotherapy for their metastatic disease receive 100 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.	Cohort 2 (Chemotherapy Naive, CN) For patients with malignant melanoma who have not received prior chemotherapy for their metastatic disease, patients receive 100 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.
Overall Study Withdrawal by Subject	1	2

Baseline Characteristics

Carboplatin and ABI-007 in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 (Prior Chemotherapy, PT) n=34 Participants Patients with malignant melanoma who have received prior chemotherapy for their metastatic disease receive 100 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.	Cohort 2 (Chemotherapy Naive, CN) n=39 Participants For patients with malignant melanoma who have not received prior chemotherapy for their metastatic disease, patients receive 100 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.	Total n=73 Participants Total of all reporting groups
Age, Continuous	60 years n=99 Participants	59 years n=107 Participants	59 years n=206 Participants
Sex: Female, Male Female	11 Participants n=99 Participants	16 Participants n=107 Participants	27 Participants n=206 Participants
Sex: Female, Male Male	23 Participants n=99 Participants	23 Participants n=107 Participants	46 Participants n=206 Participants
Region of Enrollment United States	34 participants n=99 Participants	39 participants n=107 Participants	73 participants n=206 Participants

PRIMARY outcome

Timeframe: Up to 2 years

Outcome measures

Outcome measures
Measure	Cohort 1 (Prior Chemotherapy, PT) n=34 Participants Patients with malignant melanoma who have received prior chemotherapy for their metastatic disease receive 100 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.	Cohort 2 (Chemotherapy Naive, CN) n=39 Participants For patients with malignant melanoma who have not received prior chemotherapy for their metastatic disease, patients receive 100 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.
Tumor Response Rate, as Measured by RECIST Criteria	8.8 percentage of participants Interval 2.5 to 21.3	25.6 percentage of participants Interval 14.6 to 39.6

SECONDARY outcome

Timeframe: Up to 2 years

Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), 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.

Outcome measures

Outcome measures
Measure	Cohort 1 (Prior Chemotherapy, PT) n=34 Participants Patients with malignant melanoma who have received prior chemotherapy for their metastatic disease receive 100 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.	Cohort 2 (Chemotherapy Naive, CN) n=39 Participants For patients with malignant melanoma who have not received prior chemotherapy for their metastatic disease, patients receive 100 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.
Survival Time	10.9 months Interval 4.0 to At the time follow-up was terminated for this clinical trial, several patients had not yet died. Their survival time will remain unknown and not collected.	11.1 months Interval 1.0 to At the time follow-up was terminated for this clinical trial, several patients had not yet died. Their survival time will remain unknown and not collected.

SECONDARY outcome

Timeframe: Up to 2 years

Time-to-disease progression (TTP) is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of time-to-progression will be estimated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), 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.

Outcome measures

Outcome measures
Measure	Cohort 1 (Prior Chemotherapy, PT) n=34 Participants Patients with malignant melanoma who have received prior chemotherapy for their metastatic disease receive 100 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.	Cohort 2 (Chemotherapy Naive, CN) n=39 Participants For patients with malignant melanoma who have not received prior chemotherapy for their metastatic disease, patients receive 100 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.
Time to Disease Progression	4.1 months Interval 1.0 to At the time follow-up was terminated for this clinical trial, several patients had not yet progressed or died. Their time to progression will remain unknown and not collected.	4.5 months Interval 1.0 to At the time follow-up was terminated for this clinical trial, several patients had not yet progressed or died. Their time to progression will remain unknown and not collected.

SECONDARY outcome

Timeframe: Up to 3 years

Population: Participants with Complete or Partial response, were analyzed

Duration of response is defined for all eligible patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented.

Outcome measures

Outcome measures
Measure	Cohort 1 (Prior Chemotherapy, PT) n=3 Participants Patients with malignant melanoma who have received prior chemotherapy for their metastatic disease receive 100 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.	Cohort 2 (Chemotherapy Naive, CN) n=10 Participants For patients with malignant melanoma who have not received prior chemotherapy for their metastatic disease, patients receive 100 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.
Duration of Response	3.5 months Interval 3.2 to 11.6	12.1 months Interval 4.0 to 30.6

SECONDARY outcome

Timeframe: Up to 2 years

Number of treatment cycles administered is defined to be the number of treatment cycles administered until the patient is removed from treatment due to progression, toxicity, or refusal. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), 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.

Outcome measures

Outcome measures
Measure	Cohort 1 (Prior Chemotherapy, PT) n=34 Participants Patients with malignant melanoma who have received prior chemotherapy for their metastatic disease receive 100 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.	Cohort 2 (Chemotherapy Naive, CN) n=39 Participants For patients with malignant melanoma who have not received prior chemotherapy for their metastatic disease, patients receive 100 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.
Number of Treatment Cycles Administered	4 cycles Interval 1.0 to 10.0	4 cycles Interval 1.0 to 26.0

Adverse Events

Cohort 1 (Prior Chemotherapy, PT)

Serious events: 3 serious events

Other events: 34 other events

Deaths: 0 deaths

Cohort 2 (Chemotherapy Naive, CN)

Serious events: 5 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Svetomir N. Markovic, MD, Ph.D

Mayo Clinic

Phone: (507) 284-1370

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Cohort 1 (Prior Chemotherapy, PT) n=34 participants at risk chemotherapy for their metastatic disease receive 100 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.	Cohort 2 (Chemotherapy Naive, CN) n=39 participants at risk prior chemotherapy for their metastatic disease, patients receive 100 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) IV over 30 minutes followed by AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/34 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.	2.6% 1/39 • Number of events 1 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Gastrointestinal disorders Diarrhea	0.00% 0/34 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.	2.6% 1/39 • Number of events 1 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
General disorders Fatigue	0.00% 0/34 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.	2.6% 1/39 • Number of events 1 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Infections and infestations Colitis, infectious (e.g., Clostridium difficile)	0.00% 0/34 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.	2.6% 1/39 • Number of events 1 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Infections and infestations Skin infection	0.00% 0/34 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.	2.6% 1/39 • Number of events 1 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Investigations Creatinine increased	0.00% 0/34 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.	2.6% 1/39 • Number of events 1 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Investigations Leukocyte count decreased	0.00% 0/34 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.	2.6% 1/39 • Number of events 1 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Investigations Neutrophil count decreased	2.9% 1/34 • Number of events 1 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.	2.6% 1/39 • Number of events 1 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Musculoskeletal and connective tissue disorders Joint pain	0.00% 0/34 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.	2.6% 1/39 • Number of events 1 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/34 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.	2.6% 1/39 • Number of events 1 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/34 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.	2.6% 1/39 • Number of events 1 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Nervous system disorders Seizure	2.9% 1/34 • Number of events 1 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.	0.00% 0/39 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Renal and urinary disorders Renal failure	2.9% 1/34 • Number of events 1 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.	0.00% 0/39 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Renal and urinary disorders Ureteric obstruction	2.9% 1/34 • Number of events 1 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.	0.00% 0/39 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Vascular disorders Hypotension	0.00% 0/34 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.	2.6% 1/39 • Number of events 1 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Vascular disorders Thrombosis	2.9% 1/34 • Number of events 1 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.	2.6% 1/39 • Number of events 1 • Adverse events are assessed during the Active Monitoring Phase prior to each cycle of treatment, during observation every 2 months until progression, and at time of progression; up to 2 years post-registration. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.