Trial Outcomes & Findings for Study of ABT-510 (Thrombospondin Analogue) in Patients With Advanced Head and Neck Cancer (NCT NCT00113334)
NCT ID: NCT00113334
Last Updated: 2014-08-07
Results Overview
Response rate defined as percentage of number of complete response or partial response in total number of participants treated. Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>30% decrease in sum longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): \>20% increase in sum LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1/\> new lesions; Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD, reference smallest sum LD. Trial conducted by Simon's optimal two-stage design and response rate estimated accordingly. For status of PR or CR, changes in tumor measurements confirmed by repeat assessments performed at 6 weeks, no less than 4 weeks after criteria for response is first met.
COMPLETED
PHASE1/PHASE2
6 participants
Baseline to 6 weeks for PR or CR response assessment (minimal 4 week cycle + assessments). Overall study period 3 years.
2014-08-07
Participant Flow
Recruitment Period: 06/10/05 through 03/02/07. All participants recruited at University of Texas (UT) MD Anderson Cancer Center.
Participant milestones
| Measure |
ABT-510 (Thrombospondin)
Fixed dose level of thrombospondin 100 mg subcutaneously twice daily.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of ABT-510 (Thrombospondin Analogue) in Patients With Advanced Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
ABT-510 (Thrombospondin)
n=6 Participants
Fixed dose level of thrombospondin 100 mg subcutaneously twice daily.
|
|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 weeks for PR or CR response assessment (minimal 4 week cycle + assessments). Overall study period 3 years.Population: Three (3) patients were inevaluable for response.
Response rate defined as percentage of number of complete response or partial response in total number of participants treated. Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>30% decrease in sum longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): \>20% increase in sum LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1/\> new lesions; Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD, reference smallest sum LD. Trial conducted by Simon's optimal two-stage design and response rate estimated accordingly. For status of PR or CR, changes in tumor measurements confirmed by repeat assessments performed at 6 weeks, no less than 4 weeks after criteria for response is first met.
Outcome measures
| Measure |
ABT-510 (Thrombospondin)
n=3 Participants
Fixed dose level of thrombospondin 100 mg subcutaneously twice daily.
|
|---|---|
|
Response Rate
No Change/Stable Disease
|
2 participants
|
|
Response Rate
Progressive Disease
|
1 participants
|
Adverse Events
ABT-510 (Thrombospondin)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ABT-510 (Thrombospondin)
n=6 participants at risk
Fixed dose level of thrombospondin 100 mg subcutaneously twice daily.
|
|---|---|
|
General disorders
Fatigue
|
33.3%
2/6 • 8 weeks, minimally 28 days for treatment cycle (4 weeks).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • 8 weeks, minimally 28 days for treatment cycle (4 weeks).
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • 8 weeks, minimally 28 days for treatment cycle (4 weeks).
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
1/6 • 8 weeks, minimally 28 days for treatment cycle (4 weeks).
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • 8 weeks, minimally 28 days for treatment cycle (4 weeks).
|
|
Metabolism and nutrition disorders
Weight loss
|
16.7%
1/6 • 8 weeks, minimally 28 days for treatment cycle (4 weeks).
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
16.7%
1/6 • 8 weeks, minimally 28 days for treatment cycle (4 weeks).
|
|
Metabolism and nutrition disorders
Lymphopenia
|
16.7%
1/6 • 8 weeks, minimally 28 days for treatment cycle (4 weeks).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
16.7%
1/6 • 8 weeks, minimally 28 days for treatment cycle (4 weeks).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
1/6 • 8 weeks, minimally 28 days for treatment cycle (4 weeks).
|
Additional Information
Edward Kim, MD, BS / Assistant Professor
University of Texas (UT) MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place