A Phase 2 interventional study of Tivozanib Hydrochloride and paclitaxel in Triple Negative Breast Cancer, sponsored by AVEO Pharmaceuticals, Inc.. Terminated at 54 sites in 10 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-27.
Sponsored by AVEO Pharmaceuticals, Inc. (part of LG Chem) · Phase 2, Interventional, and Treatment
This is a phase 2 multicenter, double-blind, randomized, placebo-controlled, two-arm study for subjects with locally recurrent or metastatic triple negative breast cancer.
This is a phase 2 multicenter, double-blind, randomized, placebo-controlled, two-arm study for subjects with locally recurrent or metastatic triple negative breast cancer.
Patients will be randomized 2:1 to either tivozanib hydrochloride and weekly paclitaxel or placebo and weekly paclitaxel.
Subjects will be stratified based on Eastern Cooperative Oncology Group (ECOG) performance score (0 vs 1) and line of treatment (first vs second).
All subjects will be evaluated for progression free survival and overall survival as well as safety and tolerability. Biomarker and pharmacokinetic (PK) analysis are also included in study. This study will determine whether tivozanib hydrocholoride combined with weekly paclitaxel improves clinical outcomes in patients with triple negative breast cancer.
1,219 studies on the registry are indexed under Triple Negative Breast Neoplasms; 446 are open to participants now.
This study's enrollment of 30 is below the median of 60 across 1,053 interventional studies indexed under Triple Negative Breast Neoplasms.
Browse Triple Negative Breast Neoplasms studies →AVEO Pharmaceuticals, Inc. is the lead sponsor of 35 studies on the registry; 2 are open to participants now.
First submitted before AVEO Pharmaceuticals, Inc. became part of LG Chem.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo orally once daily on a 3 weeks on/1 week off schedule with 90 mg/m2 of paclitaxel administered intravenously 3 weeks on (Day 1, Day 8 and Day 15)/1 week off (4 weeks = 1 Cycle).
Drug: paclitaxel · Drug: Placebo
1.5 mg tivozanib hydrochloride orally once daily on a 3 weeks on/1 week off schedule with 90 mg/m2 of paclitaxel administered intravenously 3 weeks on (Day 1, Day 8 and Day 15)/1 week off (4 weeks = 1 Cycle).
Drug: Tivozanib Hydrochloride · Drug: paclitaxel
Also known as: Tivozanib
Also known as: PTX
Comparison of Progression-free Survival (PFS) of Subjects
PFS is defined as the time from randomization to progressive disease (PD) or death. The PFS comparison was performed for subjects treated with tivozanib hydrochloride in combination with paclitaxel vs placebo in combination with paclitaxel.
Time frame: approximately 24 months
Comparison of Objective Response Rate (ORR) and Duration of Response (DoR) of Subjects
ORR is defined as the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period. DoR is defined as the length of time that a tumor continues to respond to treatment without the cancer growing or spreading. The ORR and DoR comparison was performed for subjects treated with tivozanib hydrochloride in combination with paclitaxel vs placebo in combination with paclitaxel.
Time frame: approximately 24 months
Comparison of Overall Survival (OS) of Subjects
OS measures how long subjects, who undergo a certain treatment regimen, live compared to subjects who are in a control group (i.e., taking either another drug or an inactive treatment, known as a placebo). OS comparison was performed for subjects treated with tivozanib hydrochloride in combination with paclitaxel vs placebo in combination with paclitaxel.
Time frame: approximately 24 months
Safety and Tolerability of Tivozanib Hydrochloride in Combination With Paclitaxel vs Placebo in Combination With Paclitaxel
Number of subjects with serious and non-serious adverse events.
Time frame: approximately 24 months
Pharmacokinetics (PK) of Tivozanib Hydrochloride and Paclitaxel When Administered in Combination
PK is defined as the study of the bodily absorption, distribution, metabolism, and excretion of drugs.
Time frame: approximately 24 months
Identification of Hypoxia Gene Signature
Evaluation of hypoxia gene signature as a predictive biomarker of tivozanib hydrochloride response and establish the optimal cut-off to identify biomarker positive and negative subgroups. The genes comprising the hypoxia gene signature was analyzed in tumor tissue from subjects.
Time frame: Cycle 1, Day 1: Pre-dose and 2, 4 and 24 hours post dose; Cycle 1, Day 8: Pre-dose; Cycle 1, Day 21: Pre-dose and 2, 4, 24, 48, and 96 hours post dose; Cycle 2 (Day 1): Pre-dose
Measurement of Subjects' Quality of Life (QoL)
The Functional Assessment of Cancer Therapy-Breast (FACT-B) and Euro Quality of Life - 5 Dimensions (EQ-5D) questionnaires was used throughout the study to measure subjects' health-related QoL.
Time frame: approximately 24 months
Participants who met all the inclusion and none of the exclusion criteria were enrolled
| Milestone | Placebo in Combination With Paclitaxel | Tivozanib Hydrochloride in Combination With Paclitaxel |
|---|---|---|
| Started | 8 | 22 |
| Treated | 8 | 21 |
| Completed | 0 | 0 |
| Not completed | 8 | 22 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 2 |
| Withdrew: Termination of the study by the sponsor | 6 | 18 |
| Withdrew: Other reasons unspecified | 0 | 2 |
PFS is defined as the time from randomization to progressive disease (PD) or death. The PFS comparison was performed for subjects treated with tivozanib hydrochloride in combination with paclitaxel vs placebo in combination with paclitaxel.
No measurements were reported for this outcome.
ORR is defined as the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period. DoR is defined as the length of time that a tumor continues to respond to treatment without the cancer growing or spreading. The ORR and DoR comparison was performed for subjects treated with tivozanib hydrochloride in combination with paclitaxel vs placebo in combination with paclitaxel.
No measurements were reported for this outcome.
OS measures how long subjects, who undergo a certain treatment regimen, live compared to subjects who are in a control group (i.e., taking either another drug or an inactive treatment, known as a placebo). OS comparison was performed for subjects treated with tivozanib hydrochloride in combination with paclitaxel vs placebo in combination with paclitaxel.
No measurements were reported for this outcome.
Number of subjects with serious and non-serious adverse events.
| Participants | Tivozanib Hydrochloride in Combination With Paclitaxel | Placebo in Combination With Paclitaxel |
|---|---|---|
| Subjects with serious adverse events | 1 | 1 |
| Subjects with non-serious adverse events | 19 | 8 |
PK is defined as the study of the bodily absorption, distribution, metabolism, and excretion of drugs.
No measurements were reported for this outcome.
Evaluation of hypoxia gene signature as a predictive biomarker of tivozanib hydrochloride response and establish the optimal cut-off to identify biomarker positive and negative subgroups. The genes comprising the hypoxia gene signature was analyzed in tumor tissue from subjects.
No measurements were reported for this outcome.
The Functional Assessment of Cancer Therapy-Breast (FACT-B) and Euro Quality of Life - 5 Dimensions (EQ-5D) questionnaires was used throughout the study to measure subjects' health-related QoL.
No measurements were reported for this outcome.
Collected over 14 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo in Combination With Paclitaxel | — | 1/8 (12.5%) | 8/8 (100%) |
| Tivozanib Hydrochloride in Combination With Paclitaxel | — | 1/21 (4.8%) | 19/21 (90.5%) |
| Event | Placebo in Combination With Paclitaxel | Tivozanib Hydrochloride in Combination With Paclitaxel |
|---|---|---|
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/8 | 0/21 |
| Brain cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/8 | 0/21 |
| DiarrhoeaGastrointestinal disorders | 0/8 | 1/21 |
| NauseaGastrointestinal disorders | 0/8 | 1/21 |
| FatigueGeneral disorders | 0/8 | 1/21 |
| DehydrationMetabolism and nutrition disorders | 0/8 | 1/21 |
| Event | Placebo in Combination With Paclitaxel | Tivozanib Hydrochloride in Combination With Paclitaxel |
|---|---|---|
| FaitgueGeneral disorders | 4/8 | 11/21 |
| AlopeciaSkin and subcutaneous tissue disorders | 4/8 | 7/21 |
| NauseaGastrointestinal disorders | 4/8 | 9/21 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/8 | 9/21 |
| NeutropeniaBlood and lymphatic system disorders | 2/8 | 8/21 |
| ConstipationGastrointestinal disorders | 3/8 | 6/21 |
| AnaemiaBlood and lymphatic system disorders | 3/8 | 5/21 |
| HypertensionVascular disorders | 0/8 | 7/21 |
| StomatitisGastrointestinal disorders | 1/8 | 6/21 |
| Oedema peripheralGeneral disorders | 2/8 | 0/21 |
| Age, Categorical(Participants) | Placebo in Combination With Paclitaxel | Tivozanib Hydrochloride in Combination With Paclitaxel | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 20 | 24 |
| >=65 years | 4 | 2 | 6 |
| Age, Continuous(years) | Placebo in Combination With Paclitaxel | Tivozanib Hydrochloride in Combination With Paclitaxel | Total |
|---|---|---|---|
| Mean | 61.3 ± 16.02 | 54.5 ± 10.06 | 56.3 ± 12.02 |
| Sex: Female, Male(Participants) | Placebo in Combination With Paclitaxel | Tivozanib Hydrochloride in Combination With Paclitaxel | Total |
|---|---|---|---|
| Female | 8 | 22 | 30 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(participants) | Placebo in Combination With Paclitaxel | Tivozanib Hydrochloride in Combination With Paclitaxel | Total |
|---|---|---|---|
| White | 8 | 14 | 22 |
| Black | 0 | 5 | 5 |
| Asian | 0 | 2 | 2 |
| Dominican | 0 | 1 | 1 |
| Body Mass Index(kg/m^2) | Placebo in Combination With Paclitaxel | Tivozanib Hydrochloride in Combination With Paclitaxel | Total |
|---|---|---|---|
| Mean | 30.6 ± 10.67 | 182.3 ± 708.53 | 144.4 ± 613.48 |
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Studies of the drug tested here: Tivozanib
Triple Negative Breast Neoplasms →