Trial Outcomes & Findings for TPI 287 in Breast Cancer Metastatic to the Brain (NCT NCT01332630)

Last Updated: 2018-09-20

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

24 participants

Primary outcome timeframe

8-24 weeks

Results posted on

2018-09-20

Participant Flow

Metastatic breast cancer any receptors status with brain metastasis

Participant milestones

Participant milestones
Measure	TPI 287 TPI 287 administered at 160 mg/m2 by vein on Day 1 and repeated every three weeks. Day 1 of each subsequent cycle is equivalent of day 22 of the previous cycle; pre TPI 287: Dexamethasone 6 mg by mouth at 12 hours and 6 hours prior to treatment. As alternative and based on the treating physician discretion, Dexamethasone 10 mgby vein may be given 30-60 minutes prior to treatment with TPI 287, Benadryl 12.5-25 mg IV push over 30-60 minutes, and Ranitidine 1mg/kg IV over 30-60 minutes. TPI 287: Starting dose Phase I: 160 mg/m2 by vein over 60 minutes on Days 1, 8, and 15 of every 28 day cycle. Starting Dose Phase II: Maximum tolerated dose from Phase I. Dexamethasone: 6 mg by mouth at 12 hours and 6 hours prior to treatment. As alternative and based on the treating physician discretion, dexamethasone 10 mg by vein may be given 30-60 minutes prior to treatment with TPI 287. Benadryl: 12.5-25 mg intravenous (IV) push 30-60 minutes prior Ranitidine: As H2 blocker 1mg/kg IV
Overall Study STARTED	24
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	TPI 287 TPI 287 administered at 160 mg/m2 by vein on Day 1 and repeated every three weeks. Day 1 of each subsequent cycle is equivalent of day 22 of the previous cycle; pre TPI 287: Dexamethasone 6 mg by mouth at 12 hours and 6 hours prior to treatment. As alternative and based on the treating physician discretion, Dexamethasone 10 mgby vein may be given 30-60 minutes prior to treatment with TPI 287, Benadryl 12.5-25 mg IV push over 30-60 minutes, and Ranitidine 1mg/kg IV over 30-60 minutes. TPI 287: Starting dose Phase I: 160 mg/m2 by vein over 60 minutes on Days 1, 8, and 15 of every 28 day cycle. Starting Dose Phase II: Maximum tolerated dose from Phase I. Dexamethasone: 6 mg by mouth at 12 hours and 6 hours prior to treatment. As alternative and based on the treating physician discretion, dexamethasone 10 mg by vein may be given 30-60 minutes prior to treatment with TPI 287. Benadryl: 12.5-25 mg intravenous (IV) push 30-60 minutes prior Ranitidine: As H2 blocker 1mg/kg IV
Overall Study Withdrawal by Subject	3

Baseline Characteristics

TPI 287 in Breast Cancer Metastatic to the Brain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1/2 n=24 Participants TPI 287 administered at 160 mg/m2 by vein on Day 1 and repeated every three weeks. Day 1 of each subsequent cycle is equivalent to day 22 of the previous cycle; pre TPI 287: Dexamethasone 6 mg by mouth at 12 hours and 6 hours prior to treatment. As alternative and based on the treating physician discretion, Dexamethasone 10 mg by vein may be given 30-60 minutes prior to treatment with TPI 287, Benadryl 12.5-25 mg IV push over 30-60 minutes, and Ranitidine 1mg/kg IV over 30-60 minutes.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	45 years n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 8-24 weeks

Outcome measures

Outcome measures
Measure	TPI 287 n=21 Participants TPI 287 administered at 160 mg/m2 by vein on Day 1 and repeated every three weeks. Day 1 of each subsequent cycle is equivalent of day 22 of the previous cycle; pre TPI 287: Dexamethasone 6 mg by mouth at 12 hours and 6 hours prior to treatment. As alternative and based on the treating physician discretion, Dexamethasone 10 mg by vein may be given 30-60 minutes prior to treatment with TPI 287, Benadryl 12.5-25 mg IV push over 30-60 minutes, and Ranitidine 1mg/kg IV over 30-60 minutes.
Overall Response Rate (ORR)	21 Participants

Adverse Events

TPI 287

Serious events: 6 serious events

Other events: 21 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	TPI 287 n=21 participants at risk TPI 287 administered at 160 mg/m2 by vein on Day 1 and repeated every three weeks. Day 1 of each subsequent cycle is equivalent of day 22 of the previous cycle; pre TPI 287: Dexamethasone 6 mg by mouth at 12 hours and 6 hours prior to treatment. As alternative and based on the treating physician discretion, Dexamethasone 10 mgby vein may be given 30-60 minutes prior to treatment with TPI 287, Benadryl 12.5-25 mg IV push over 30-60 minutes, and Ranitidine 1mg/kg IV over 30-60 minutes.
Nervous system disorders Dizziness	14.3% 3/21 • Collected every 28 days with an average of up to a year.
Nervous system disorders Syncope	9.5% 2/21 • Collected every 28 days with an average of up to a year.
Respiratory, thoracic and mediastinal disorders Dyspnea	9.5% 2/21 • Collected every 28 days with an average of up to a year.
Musculoskeletal and connective tissue disorders Fracture	4.8% 1/21 • Collected every 28 days with an average of up to a year.
Cardiac disorders Hypertension	14.3% 3/21 • Collected every 28 days with an average of up to a year.
Cardiac disorders Edema	14.3% 3/21 • Collected every 28 days with an average of up to a year.
Respiratory, thoracic and mediastinal disorders Hypoxia	14.3% 3/21 • Collected every 28 days with an average of up to a year.
Gastrointestinal disorders Nausea	9.5% 2/21 • Collected every 28 days with an average of up to a year.
Nervous system disorders Headache	9.5% 2/21 • Collected every 28 days with an average of up to a year.

Other adverse events

Other adverse events
Measure	TPI 287 n=21 participants at risk TPI 287 administered at 160 mg/m2 by vein on Day 1 and repeated every three weeks. Day 1 of each subsequent cycle is equivalent of day 22 of the previous cycle; pre TPI 287: Dexamethasone 6 mg by mouth at 12 hours and 6 hours prior to treatment. As alternative and based on the treating physician discretion, Dexamethasone 10 mgby vein may be given 30-60 minutes prior to treatment with TPI 287, Benadryl 12.5-25 mg IV push over 30-60 minutes, and Ranitidine 1mg/kg IV over 30-60 minutes.
Skin and subcutaneous tissue disorders Alopecia	14.3% 3/21 • Collected every 28 days with an average of up to a year.
Blood and lymphatic system disorders Anemia	4.8% 1/21 • Collected every 28 days with an average of up to a year.
Respiratory, thoracic and mediastinal disorders Cough	9.5% 2/21 • Collected every 28 days with an average of up to a year.
Blood and lymphatic system disorders Decreased ANC	9.5% 2/21 • Collected every 28 days with an average of up to a year.
Blood and lymphatic system disorders Decreased Lymphocytes	9.5% 2/21 • Collected every 28 days with an average of up to a year.
Blood and lymphatic system disorders Decreased WBC	14.3% 3/21 • Collected every 28 days with an average of up to a year.
Nervous system disorders Dizziness	4.8% 1/21 • Collected every 28 days with an average of up to a year.
Nervous system disorders Dysphagia	9.5% 2/21 • Collected every 28 days with an average of up to a year.
Nervous system disorders Dyspnea	4.8% 1/21 • Collected every 28 days with an average of up to a year.
Blood and lymphatic system disorders Increased alk phos	4.8% 1/21 • Collected every 28 days with an average of up to a year.
Blood and lymphatic system disorders increased AST	4.8% 1/21 • Collected every 28 days with an average of up to a year.
Cardiac disorders Edema limbs	4.8% 1/21 • Collected every 28 days with an average of up to a year.
Metabolism and nutrition disorders Fatigue	23.8% 5/21 • Collected every 28 days with an average of up to a year.
Immune system disorders Fever	4.8% 1/21 • Collected every 28 days with an average of up to a year.
Musculoskeletal and connective tissue disorders Fracture	9.5% 2/21 • Collected every 28 days with an average of up to a year.
Immune system disorders Hand foot syndrone	14.3% 3/21 • Collected every 28 days with an average of up to a year.
Nervous system disorders Headache	4.8% 1/21 • Collected every 28 days with an average of up to a year.
Endocrine disorders Hyperglycemia	4.8% 1/21 • Collected every 28 days with an average of up to a year.
Cardiac disorders HTN	4.8% 1/21 • Collected every 28 days with an average of up to a year.
Blood and lymphatic system disorders Hypoalbuninemia	4.8% 1/21 • Collected every 28 days with an average of up to a year.
Respiratory, thoracic and mediastinal disorders Hypoxia	4.8% 1/21 • Collected every 28 days with an average of up to a year.
Infections and infestations Infection	4.8% 1/21 • Collected every 28 days with an average of up to a year.
Musculoskeletal and connective tissue disorders Muscle Cramps	9.5% 2/21 • Collected every 28 days with an average of up to a year.
Gastrointestinal disorders Nausea	9.5% 2/21 • Collected every 28 days with an average of up to a year.
Nervous system disorders Neuropathy	33.3% 7/21 • Collected every 28 days with an average of up to a year.
General disorders Pain	14.3% 3/21 • Collected every 28 days with an average of up to a year.
Nervous system disorders Seizure	4.8% 1/21 • Collected every 28 days with an average of up to a year.
Skin and subcutaneous tissue disorders Skin tissue disorder	9.5% 2/21 • Collected every 28 days with an average of up to a year.
Cardiac disorders Syncope	4.8% 1/21 • Collected every 28 days with an average of up to a year.
General disorders Vaginal candidiasis	4.8% 1/21 • Collected every 28 days with an average of up to a year.
Gastrointestinal disorders Vomiting	4.8% 1/21 • Collected every 28 days with an average of up to a year.

Additional Information

Ibrahim,Nuhad K.,M.D. / Breast Medical Oncology

UT MD Anderson Cancer Center

Phone: 713-792-7734

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place