Trial Outcomes & Findings for SB-715992 in Treating Patients With Advanced or Metastatic Colorectal Cancer (NCT NCT00103311)

Last Updated: 2015-03-02

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

64 participants

Primary outcome timeframe

Up to 5 years

Results posted on

2015-03-02

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ispinesib: Given IV laboratory biomarker analysis: Correlative studies	Arm II Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ispinesib: Given IV laboratory biomarker analysis: Correlative studies
Overall Study STARTED	33	31
Overall Study COMPLETED	29	30
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ispinesib: Given IV laboratory biomarker analysis: Correlative studies	Arm II Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ispinesib: Given IV laboratory biomarker analysis: Correlative studies
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	2	1
Overall Study Adverse Event	1	0

Baseline Characteristics

SB-715992 in Treating Patients With Advanced or Metastatic Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I n=33 Participants Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ispinesib: Given IV laboratory biomarker analysis: Correlative studies	Arm II n=31 Participants Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ispinesib: Given IV laboratory biomarker analysis: Correlative studies	Total n=64 Participants Total of all reporting groups
Age, Continuous	59 years n=5 Participants	60 years n=7 Participants	59 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants	31 participants n=7 Participants	64 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome measures
Measure	Arm I n=33 Participants Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ispinesib: Given IV laboratory biomarker analysis: Correlative studies	Arm II n=31 Participants Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ispinesib: Given IV laboratory biomarker analysis: Correlative studies
Objective Response (CR or PR) as Determined by the RECIST Criteria	0 participants	0 participants

SECONDARY outcome

Timeframe: From the date of registration to the date of documented PSA progression, assessed up to 6 months

Will be estimated using the product-limit method of Kaplan and Meier by arm. 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	Arm I n=33 Participants Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ispinesib: Given IV laboratory biomarker analysis: Correlative studies	Arm II n=31 Participants Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ispinesib: Given IV laboratory biomarker analysis: Correlative studies
Progression-free Survival	7.0 weeks Interval 6.3 to 7.3	5.3 weeks Interval 5.0 to 5.9

SECONDARY outcome

Timeframe: From the date of registration to the date of death, assessed up to 12 months

Will be estimated using the product-limit method of Kaplan and Meier by arm.

Outcome measures

Outcome measures
Measure	Arm I n=33 Participants Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ispinesib: Given IV laboratory biomarker analysis: Correlative studies	Arm II n=31 Participants Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ispinesib: Given IV laboratory biomarker analysis: Correlative studies
Overall Survival	3.6 months Interval 2.5 to 8.2	4.5 months Interval 3.7 to 7.0

Adverse Events

Arm I

Serious events: 14 serious events

Other events: 33 other events

Deaths: 0 deaths

Arm II

Serious events: 13 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

DCC Project Administrator

California Cancer Consortium

Phone: 626-256-4673

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Arm I n=33 participants at risk Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ispinesib: Given IV laboratory biomarker analysis: Correlative studies	Arm II n=31 participants at risk Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ispinesib: Given IV laboratory biomarker analysis: Correlative studies
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/33 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.2% 1/31 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Hemoglobin decreased	3.0% 1/33 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/31 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	9.1% 3/33 • Number of events 4 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.2% 1/31 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Ileal obstruction	3.0% 1/33 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/31 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	12.1% 4/33 • Number of events 5 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.2% 1/31 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Rectal hemorrhage	3.0% 1/33 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/31 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Small intestinal stenosis	0.00% 0/33 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.2% 1/31 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	9.1% 3/33 • Number of events 3 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.2% 1/31 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Death	0.00% 0/33 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.2% 1/31 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Disease progression	6.1% 2/33 • Number of events 2 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.9% 4/31 • Number of events 4 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	3.0% 1/33 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/31 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	3.0% 1/33 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/31 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Multi-organ failure	3.0% 1/33 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/31 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Hepatobiliary disorders Gallbladder obstruction	0.00% 0/33 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.5% 2/31 • Number of events 2 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Catheter related infection	0.00% 0/33 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.2% 1/31 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Kidney infection	0.00% 0/33 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.2% 1/31 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Sepsis	0.00% 0/33 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.2% 1/31 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Skin infection	0.00% 0/33 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.2% 1/31 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alanine aminotransferase increased	0.00% 0/33 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.5% 2/31 • Number of events 2 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline phosphatase increased	3.0% 1/33 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.5% 2/31 • Number of events 2 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/33 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.2% 1/31 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hyperbilirubinemia	3.0% 1/33 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.7% 3/31 • Number of events 3 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations INR increased	3.0% 1/33 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/31 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	0.00% 0/33 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.8% 8/31 • Number of events 8 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Anorexia	3.0% 1/33 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/31 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Dehydration	12.1% 4/33 • Number of events 4 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.2% 1/31 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/33 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.2% 1/31 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/33 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.2% 1/31 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Iron increased	0.00% 0/33 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.2% 1/31 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Back pain	6.1% 2/33 • Number of events 2 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/31 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Ischemia cerebrovascular	0.00% 0/33 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.2% 1/31 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/33 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.2% 1/31 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	3.0% 1/33 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.2% 1/31 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypotension	6.1% 2/33 • Number of events 2 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/31 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Thrombosis	3.0% 1/33 • Number of events 1 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/31 • Adverse events were over a period of 4 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.