Trial Outcomes & Findings for Gemcitabine and Docetaxel in Combination With Pazopanib (Gem/Doce/Pzb) for the Neoadjuvant Treatment of Soft Tissue Sarcoma (STS) (NCT NCT01418001)

NCT ID: NCT01418001

Last Updated: 2018-01-11

Results Overview

Overall objective response measured using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: Every 6 weeks up to 2 years
• Results posted on: 2018-01-11

Participant Flow

Participant milestones

Measure	Pazopanib 400 mg QD Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gemcitabine and Docetaxel in Combination With Pazopanib (Gem/Doce/Pzb) for the Neoadjuvant Treatment of Soft Tissue Sarcoma (STS)

Baseline characteristics by cohort

Measure	Level 1: Pazopanib 400 mg QD Gemcitabine and Docetaxel in Com n=5 Participants Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants
Age, Categorical >=65 years	4 Participants n=93 Participants
Sex: Female, Male Female	1 Participants n=93 Participants
Sex: Female, Male Male	4 Participants n=93 Participants

PRIMARY outcome

Timeframe: Every 6 weeks up to 2 years

Overall objective response measured using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).

Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Outcome measures

Measure	Level 1: Pazopanib 400 mg QD n=5 Participants Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
Overall Objective Response Complete Response (CR)	3 participants
Overall Objective Response Stable Disease (SD)	2 participants

SECONDARY outcome

Timeframe: 2 years

Population: No data is available because data was not collected due to lack of accrual.

will be assessed by both MRI and by pathologic review after surgery. An estimate of each response rate and the 95% CI will be provided

Outcome measures

Outcome data not reported

Adverse Events

Level 1: Pazopanib 400 mg QD

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Level 1: Pazopanib 400 mg QD n=5 participants at risk Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
Infections and infestations Wound infection	20.0% 1/5
General disorders Fatigue	20.0% 1/5
Blood and lymphatic system disorders Alanine aminotransferase increased	20.0% 1/5

Other adverse events

Measure	Level 1: Pazopanib 400 mg QD n=5 participants at risk Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
Blood and lymphatic system disorders Alanine aminotransferase increased	40.0% 2/5
Blood and lymphatic system disorders Anemia	80.0% 4/5
Blood and lymphatic system disorders Aspartate aminotransferase increased	20.0% 1/5
Gastrointestinal disorders Diarrhea	20.0% 1/5
General disorders Fatigue	40.0% 2/5
General disorders Hoarseness	20.0% 1/5
Metabolism and nutrition disorders Hyperglycemia	40.0% 2/5
Cardiac disorders Hypertension	20.0% 1/5
Metabolism and nutrition disorders Hypertriglyceridemia	40.0% 2/5
Metabolism and nutrition disorders Hypoalbuminemia	40.0% 2/5
Metabolism and nutrition disorders Hypocalcemia	40.0% 2/5
Metabolism and nutrition disorders Hyponatremia	20.0% 1/5
Blood and lymphatic system disorders Lymphocyte count decreased	40.0% 2/5
General disorders Mucositis oral	20.0% 1/5
Gastrointestinal disorders Nausea	20.0% 1/5
Blood and lymphatic system disorders Platelet count decreased	20.0% 1/5

Additional Information

Dr. William Tap

Memorial Sloan Kettering Cancer Center

Phone: 646-888-4163

Email: tapw@mskcc.org

Results disclosure agreements

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