Trial Outcomes & Findings for Pazopanib in Combination With Capecitabine in Patients With Metastatic Breast Cancer (NCT NCT01498458)

NCT ID: NCT01498458

Last Updated: 2022-06-10

Results Overview

The maximum tolerated dose (MTD) is defined as the highest dose level with DLT in no more than 1 out of 6 patients. A maximal tolerated dose (MTD) could not be established.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 9 participants
• Primary outcome timeframe: 3 years
• Results posted on: 2022-06-10

Participant Flow

9 patients were registered in the study but patient number 9 withdrew consent immediately without receiving any Pazopanib.

Participant milestones

Measure	Pazopanib Plus Capecitabine The baseline refers only to the 8 patients who received Pazopanib.
Overall Study STARTED	8
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Pazopanib Plus Capecitabine The baseline refers only to the 8 patients who received Pazopanib.
Overall Study Adverse Event	4
Overall Study Physician Decision	3

Baseline Characteristics

Pazopanib in Combination With Capecitabine in Patients With Metastatic Breast Cancer

Baseline characteristics by cohort

Measure	Pazopanib Plus Capecitabine n=8 Participants pazopanib plus capecitabine
Age, Customized premenopausal	1 participants n=5 Participants
Age, Customized Postmenopausal	7 participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
ECOG ECOG 0	6 participants n=5 Participants
ECOG ECOG 1	2 participants n=5 Participants
T status T1	2 participants n=5 Participants
T status T2	3 participants n=5 Participants
T status T3	0 participants n=5 Participants
T status T4	2 participants n=5 Participants
T status Tis	1 participants n=5 Participants
N Status N0	2 participants n=5 Participants
N Status N1	5 participants n=5 Participants
N Status N2	0 participants n=5 Participants
N Status N3	1 participants n=5 Participants
Grading G1	0 participants n=5 Participants
Grading G2	5 participants n=5 Participants
Grading G3	3 participants n=5 Participants
Hormone Receptor Status ERneg/PRneg	2 participants n=5 Participants
Hormone Receptor Status ERneg/PRpos	1 participants n=5 Participants
Hormone Receptor Status ERpos/PRneg	2 participants n=5 Participants
Hormone Receptor Status ERpos/PRpos	3 participants n=5 Participants
HER2 Status Her2 Negative	8 participants n=5 Participants
HER2 Status Her2 Positive	0 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

The maximum tolerated dose (MTD) is defined as the highest dose level with DLT in no more than 1 out of 6 patients. A maximal tolerated dose (MTD) could not be established.

Outcome measures

Measure	Pazopanib Plus Capecitabine n=8 Participants A maximal tolerated dose (MTD) could not be established. The study was stopped after 8 patients.
Maximum Tolerable Dose (MTD) of Pazopanib	NA mg no patients reached the second dose level.

SECONDARY outcome

Timeframe: 3 years

Outcome measures

Measure	Pazopanib Plus Capecitabine n=8 Participants A maximal tolerated dose (MTD) could not be established. The study was stopped after 8 patients.
Dose-limiting Toxicity (DLT)	5 participants

SECONDARY outcome

Timeframe: 3 years

Outcome measures

Measure	Pazopanib Plus Capecitabine n=8 Participants A maximal tolerated dose (MTD) could not be established. The study was stopped after 8 patients.
Hematological Toxicity of the Combination of Pazopanib and Capecitabine Anemia Grade 1 to 4	88 Number of cycles
Hematological Toxicity of the Combination of Pazopanib and Capecitabine Leucopenia Grade 1 to 4	55 Number of cycles
Hematological Toxicity of the Combination of Pazopanib and Capecitabine Number of Cycles	132 Number of cycles

SECONDARY outcome

Timeframe: 3 years

Population: 6 patients experience 6 Serious Adverse Reactions

Outcome measures

Measure	Pazopanib Plus Capecitabine n=8 Participants A maximal tolerated dose (MTD) could not be established. The study was stopped after 8 patients.
Other Toxicity of the Combination of Pazopanib and Capecitabine Hepatotoxicity	3 participants
Other Toxicity of the Combination of Pazopanib and Capecitabine Hypertension	1 participants
Other Toxicity of the Combination of Pazopanib and Capecitabine Pancreatectomy	1 participants
Other Toxicity of the Combination of Pazopanib and Capecitabine Thrombocytopenia	1 participants

SECONDARY outcome

Timeframe: 3 years

Population: All patients are included when determining this rate.

To determine the objective response rate (ORR) in patients with measurable disease. ORR consists of complete response and partial response according to the RECIST criteria. Complete Response refers to the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to less than 10 mm. Partial Response refers to an at least 30 percent decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Measure	Pazopanib Plus Capecitabine n=8 Participants A maximal tolerated dose (MTD) could not be established. The study was stopped after 8 patients.
Objective Response Rate (ORR)	0 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Population: All patients are included when determining this rate.

To determine the clinical benefit rate (CBR) in patients with measurable disease. CBR consists of complete response , partial response, and stable disease lasting greater than 24 weeks. All patients are included when determining this rate. 2 patients were on study treatment for a long time.Hence the outcome rate of 25 percent ( 2 from 8 patients)

Outcome measures

Measure	Pazopanib Plus Capecitabine n=8 Participants A maximal tolerated dose (MTD) could not be established. The study was stopped after 8 patients.
Clinical Benefit Rate (CBR)	25 percentage of participants

Adverse Events

Pazopanib Plus Capecitabine

Serious events: 6 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pazopanib Plus Capecitabine n=8 participants at risk There was only one arm in this study as this was a dose escalation study.
Hepatobiliary disorders Hepatotoxicity	37.5% 3/8 • 24 months
Cardiac disorders Hypertension	12.5% 1/8 • 24 months
Hepatobiliary disorders Pancreatectomy	12.5% 1/8 • 24 months
Blood and lymphatic system disorders Thrombocytopenia	12.5% 1/8 • 24 months

Other adverse events

Measure	Pazopanib Plus Capecitabine n=8 participants at risk There was only one arm in this study as this was a dose escalation study.
General disorders Fatigue	100.0% 8/8 • 24 months
Blood and lymphatic system disorders anemia	100.0% 8/8 • 24 months
Blood and lymphatic system disorders Neutropenia	50.0% 4/8 • 24 months
Blood and lymphatic system disorders Thrombocytopenia	87.5% 7/8 • 24 months
Hepatobiliary disorders alkaline Phosphatase	25.0% 2/8 • 24 months
Hepatobiliary disorders ASAT	87.5% 7/8 • 24 months
Hepatobiliary disorders Bilirubinaemia	37.5% 3/8 • 24 months
General disorders Fatigue CTC grade 3	12.5% 1/8 • Number of events 1 • 24 months
Gastrointestinal disorders Nausea CTC grade 3	12.5% 1/8 • Number of events 1 • 24 months
Gastrointestinal disorders Mucositis CTC grade 3	12.5% 1/8 • Number of events 1 • 24 months
Skin and subcutaneous tissue disorders Hand-foot syndrome	12.5% 1/8 • Number of events 2 • 24 months

Additional Information

Dr. Andreas Schneeweiss

University Hospital Heidelberg

Phone: +49 (0)6221 56 36051

Email: andreas.schneeweiss@med.uni-heidelberg.de

Results disclosure agreements

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