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Trial Outcomes & Findings for SB-715992 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer (NCT NCT00095628)

NCT ID: NCT00095628

Last Updated: 2017-03-06

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 lesion

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

Up to 18 months

Results posted on

2017-03-06

Participant Flow

Participant milestones

Participant milestones
Measure
Treatment (Ispinesib)
Patients receive SB-715992 IV 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 pharmacological study: Correlative studies
Overall Study
STARTED
21
Overall Study
COMPLETED
20
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Treatment (Ispinesib)
Patients receive SB-715992 IV 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 pharmacological study: Correlative studies
Overall Study
Disease progression prior to treatment
1

Baseline Characteristics

SB-715992 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Treatment (Ispinesib)
n=20 Participants
Patients receive SB-715992 IV 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 pharmacological study: Correlative studies
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
13 Participants
n=5 Participants
Age, Categorical
>=65 years
7 Participants
n=5 Participants
Age, Continuous
60 participants
n=5 Participants
Gender
Female
3 Participants
n=5 Participants
Gender
Male
17 Participants
n=5 Participants
Region of Enrollment
Canada
18 participants
n=5 Participants
Region of Enrollment
United States
2 participants
n=5 Participants

PRIMARY outcome

Timeframe: Up to 18 months

Population: 20 eligible patients were analyzed

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 lesion

Outcome measures

Outcome measures
Measure
Treatment (Ispinesib)
n=20 Participants
Patients receive SB-715992 IV 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 pharmacological study: Correlative studies
Antitumor Activity of SB-715992 Using Objective Response Rates (Partial and Complete Responses)
0 participants

SECONDARY outcome

Timeframe: Up to 18 months

Population: Data were not collected because 0 participants showed a response.

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 lesion

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 18 months

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease.

Outcome measures

Outcome measures
Measure
Treatment (Ispinesib)
n=20 Participants
Patients receive SB-715992 IV 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 pharmacological study: Correlative studies
Number of Participants With Clinical and Objective Stable Disease
5 participants

SECONDARY outcome

Timeframe: Up to 18 months

Overall survival is defined as the time from enrolment until death due to any cause. The Kaplan-Meier method was used to estimate overall survival.

Outcome measures

Outcome measures
Measure
Treatment (Ispinesib)
n=20 Participants
Patients receive SB-715992 IV 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 pharmacological study: Correlative studies
Median Overall Survival of SB-715992
3.5 months
Interval 2.8 to 7.8

SECONDARY outcome

Timeframe: Up to 18 months

Time to progression (TTP) is defined as the time from enrolment onto the study until progression or death. The Kaplan-Meier method was used to estimate TTP.

Outcome measures

Outcome measures
Measure
Treatment (Ispinesib)
n=20 Participants
Patients receive SB-715992 IV 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 pharmacological study: Correlative studies
Median Time to Progression
1.4 months
Interval 1.3 to 2.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Overall survival is defined as the time from enrolment until death due to any cause. The Kaplan-Meier method was used to estimate overall survival.

Outcome measures

Outcome measures
Measure
Treatment (Ispinesib)
n=20 Participants
Patients receive SB-715992 IV 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 pharmacological study: Correlative studies
1 Year Overall Survival
20 percentage of participants
Interval 8.3 to 48.1

Adverse Events

Treatment (Ispinesib)

Serious events: 6 serious events
Other events: 20 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Treatment (Ispinesib)
n=20 participants at risk
Patients receive SB-715992 IV 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 pharmacological study: Correlative studies
Metabolism and nutrition disorders
Anorexia
5.0%
1/20 • Number of events 1
Respiratory, thoracic and mediastinal disorders
Cough
5.0%
1/20 • Number of events 1
Respiratory, thoracic and mediastinal disorders
Dyspnea
10.0%
2/20 • Number of events 2
Investigations
Leukopenia
5.0%
1/20 • Number of events 1
Investigations
Neutropenia
5.0%
1/20 • Number of events 1
Metabolism and nutrition disorders
Hyperkalemia
5.0%
1/20 • Number of events 1
Infections and infestations
Pneumonia
5.0%
1/20 • Number of events 1
Injury, poisoning and procedural complications
Tracheal hemorrhage
5.0%
1/20 • Number of events 1
General disorders
Edema face
5.0%
1/20 • Number of events 1
Blood and lymphatic system disorders
Febrile neutropenia
10.0%
2/20 • Number of events 2
Infections and infestations
Upper respiratory infection
5.0%
1/20 • Number of events 1
Injury, poisoning and procedural complications
Injury to superior vena cava
5.0%
1/20 • Number of events 1
Injury, poisoning and procedural complications
Tracheal obstruction
5.0%
1/20 • Number of events 1

Other adverse events

Other adverse events
Measure
Treatment (Ispinesib)
n=20 participants at risk
Patients receive SB-715992 IV 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 pharmacological study: Correlative studies
Investigations
Neutropenia
70.0%
14/20
Investigations
Leukopenia
75.0%
15/20
Gastrointestinal disorders
Nausea
45.0%
9/20
Investigations
Lymphopenia
45.0%
9/20
Blood and lymphatic system disorders
Anemia
30.0%
6/20
Metabolism and nutrition disorders
Hyponatremia
30.0%
6/20
General disorders
Fatigue
25.0%
5/20
Metabolism and nutrition disorders
Hypoalbuminemia
15.0%
3/20
Skin and subcutaneous tissue disorders
Injection site reaction
15.0%
3/20
Gastrointestinal disorders
Vomiting
15.0%
3/20
Musculoskeletal and connective tissue disorders
Bone pain
5.0%
1/20

Additional Information

Dr. Eric Winquist

London Regional Cancer Centre

Phone: 519-685-8600

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60