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Adult AngiosarcomaPhase 2NCT01462630

Pazopanib Hydrochloride in Treating Patients With Advanced Angiosarcoma

A Phase 2 study testing pazopanib hydrochloride, laboratory biomarker analysis and positron emission tomography in people with Adult Angiosarcoma and Recurrent Adult Soft Tissue Sarcoma, run by Fox Chase Cancer Center at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II trial studies how well pazopanib hydrochloride works in treating patients with advanced angiosarcoma. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
pazopanib hydrochloride, laboratory biomarker analysis and positron emission tomography
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
5 sitesUnited States
Study dates
3 Nov 2011to 12 Jan 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up
  • Note: informed consent may be obtained prior to start of the specified screening window
  • Note: procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study such as bone scan) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol
  • Histologically or cytologically proven diagnosis of advanced stage angiosarcoma that is not amenable to treatment with curative intent; specify site of origin as cutaneous vs. non-cutaneous
  • Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
  • Must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 or cutaneous disease amenable to serial measurements should be present; a measurable lesion is defined as a lesion that can be accurately measured in at least one dimension with the longest diameter >= 10 mm with computed tomography (CT) scan; lesions that have been treated with therapeutic intent will be considered measurable if they have increased in size by more than 20%
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  • Absolute neutrophil count (ANC) >= 1.5 X 10^9/L
  • Hemoglobin >= 9 g/dL (5.6 mmol/L)
  • Platelets >= 100 X 10^9/L
  • International normalized ratio (INR) =< 1.2 X upper limit of normal (ULN)
  • Activated partial thromboplastin time (aPTT) =< 1.2 X ULN
  • Total bilirubin =< 1.5 X ULN (may not have abnormalities in both bilirubin and transaminases)
  • Alanine amino transferase (ALT) and aspartate aminotransferase (AST) =< 2.5 X ULN (may not have abnormalities in both bilirubin and transaminases)
  • Serum creatinine =< 1.5 mg/dL (133 umol/L)
  • Or, if serum creatinine > 1.5 mg/dL: calculated creatinine clearance (ClCR) > 50 mL/min
  • Urine Protein to Creatinine Ratio (UPC) < 1
  • Able to swallow pills whole and retain oral medication
  • A female is eligible to enter and participate in this study if the following apply:
  • Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:
  • A hysterectomy
  • A bilateral oophorectomy (ovariectomy)
  • A bilateral tubal ligation
  • Is post-menopausal
  • Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40pg/mL (< 140 pmol/L)
  • Subjects using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT
  • Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment and for 3 months after the completion of treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception; acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow:
  • Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product
  • Oral contraceptive, either combined or progestogen alone
  • Injectable progestogen
  • Implants of levonorgestrel
  • Estrogenic vaginal ring
  • Percutaneous contraceptive patches
  • Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year
  • Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject
  • Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
  • Female subjects who are lactating must discontinue nursing prior to the first dose of study drug and refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug
  • A male is eligible to enter and participate in this study if he and his female sexual partner in the reproductive age group agree to use effective methods of contraception

Who cannot join

  • Prior malignancy:
  • Subjects with a history of a prior malignancy other than angiosarcoma who have been disease-free for at least 2 years prior to the first dose of study drug and/or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible
  • History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medications for 3 months prior to first dose of study drug; screening with CNS imaging studies (CT or magnetic resonance imaging [MRI]) is required only if clinically indicated or if the subject has a history of CNS metastases
  • Clinically significant gastrointestinal (GI) abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
  • Active peptic ulcer disease
  • Known intraluminal metastatic lesion/s with risk of bleeding
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  • Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation
  • History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment
  • Clinically significant (> 1/2 teaspoon) hemoptysis or gastrointestinal hemorrhage in the past 6 months
  • Evidence of active bleeding or bleeding diathesis; recent hemoptysis (>= 1/2 teaspoon of red blood within 8 weeks before first dose of study drug)
  • Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
  • Malabsorption syndrome
  • Major resection of the stomach or small bowel
  • Corrected QT interval (QTc) > 480 msecs using Bazett's formula
  • Left ventricular ejection fraction < 50%
  • History of any one or more of the following cardiovascular conditions within the past 6 months:
  • Cardiac angioplasty or stenting
  • Myocardial infarction
  • Unstable angina
  • Coronary artery bypass graft surgery
  • Symptomatic peripheral vascular disease
  • Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
  • Poorly controlled hypertension (defined as systolic blood pressure [SBP] of >= 140 mmHg or diastolic blood pressure [DBP] of >= 90mmHg); Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry; following antihypertensive medication initiation or adjustment, blood pressure (BP) must be re-assessed three times at approximately 2-minute intervals; at least 24 hours must have elapsed between anti-hypertensive medication initiation or adjustment and BP measurement; these three values should be averaged to obtain the mean diastolic blood pressure and the mean systolic blood pressure; the mean SBP / DBP ratio must be < 140/90 mmHg in order for a subject to be eligible for the study
  • Cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
  • Note: subjects with recent DVT who have been therapeutically coagulated for at least 6 weeks are eligible
  • Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major surgery)
  • Evidence of active bleeding or bleeding diathesis; recent hemoptysis (>= ½ teaspoon of red blood within 8 weeks before first dose of study drug)
  • Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels (Note: tumor abutting the vessel is acceptable, but contiguous tumor and vessel is not; CT with contrast is strongly recommended to evaluate such lesions)
  • Abnormal serum calcium, magnesium, or potassium levels
  • Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures
  • Use of any prohibited medication within the timeframes
  • Treatment with any of the following therapies:
  • Radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib hydrochloride OR
  • Chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib
  • Patients who require chronic use of strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers including but not limited to grapefruit juice
  • Any ongoing toxicity from prior anti-cancer therapy that is > Grade 1 (except hemoglobin value) and/or that is progressing in severity, except alopecia
  • Previous exposure to pazopanib hydrochloride or a vascular endothelial growth factor receptor (VEGFR) targeted kinase therapy, except for bevacizumab or VEGFR-Trap (Aflibercept)
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Hollings Cancer Center Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern University

    Chicago, Illinois, 60611

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111-2497

Other trials in United States

About this study

Official title: Phase II Study Evaluating the Role of Pazopanib in Angiosarcoma

This phase II trial studies how well pazopanib hydrochloride works in treating patients with advanced angiosarcoma. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the progression free survival (PFS) at 3 months and response rate defined as complete response (CR) and partial response (PR) in angiosarcoma patients treated with pazopanib.

SECONDARY OBJECTIVES:

  1. To assess overall survival of patients treated with pazopanib. II. To gather more safety data for pazopanib in this patient population. III. To explore the ability of [F-18] fludeoxyglucose (FDG) (positron emission tomography [PET])/computed tomography (CT) imaging to assess response.

OUTLINE:

Patients receive pazopanib hydrochloride orally (PO) once daily (QD). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years.

Being tested
pazopanib hydrochloride, laboratory biomarker analysis, positron emission tomography, computed tomography, fludeoxyglucose F 18
Medical subject headings
Hemangiosarcoma, Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pazopanib hydrochlorideDrug

    Also called GW786034B, Votrient

    Given PO

  • laboratory biomarker analysisOther

    Correlative studies

  • positron emission tomographyProcedure or surgery

    Also called FDG-PET, PET, PET scan, tomography, emission computed

    Correlative studies

  • computed tomographyProcedure or surgery

    Also called tomography, computed

    Correlative studies

  • fludeoxyglucose F 18Radiation

    Also called 18FDG, FDG

    Correlative studies

Study groups in NCT01462630
Study groupRoleWhat they receive
Treatment (enzyme inhibitor therapy)ExperimentalPatients receive pazopanib hydrochloride PO QD. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: pazopanib hydrochloride; Other: laboratory biomarker analysis; Procedure: positron emission tomography; Procedure: computed tomography; Radiation: fludeoxyglucose F 18

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS Rate

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. PFS was estimated using the method of Kaplan and Meier.

    Measured: 3 months

  2. Response Rate Defined as CR

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Standard estimates of the binomial proportion will be used to estimate and place confidence bounds on the several response rates.

    Measured: 3 months

  3. Response Rate Defined as Partial Response (PR)

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Partial Response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Standard estimates of the binomial proportion will be used to estimate and place confidence bounds on the several response rates.

    Measured: 3 months

Secondary outcomes (3)

  1. Overall Survival of Patients Treated With Pazopanib Hydrochloride

    Estimated using the method of Kaplan and Meier.

    Measured: Up to 107 weeks

  2. Evaluation of Toxicity of Pazopanib Hydrochloride in This Patient Population

    Toxicities related/unrelated to study treatment with >10% frequency

    Measured: Up to 2 years

  3. Ability of [F-18] FDG PET/CT as an Imaging Agent in Predicting Efficacy or Early Response as Compared With CT Imaging

    Descriptive statistics will include mean, SD, median, minimum, and maximum for continuous variables and the numbers and percentages for categorical variables. Summary statistics for changes in SUVs, tumor to background ratios, lesion size, and comparison scores will be analyzed and presented.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2011 (estimated)
  2. Study start3 Nov 2011
  3. Primary completion2 Jan 2019
  4. Study completion12 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01462630
Sponsor's protocol ID
SAR-043
Other IDs
NCI-2011-01314, 11-042, OER-SAR-043, P30CA006927
Status last verified
Jul 2022
First submitted
27 Oct 2011
Last updated
19 Aug 2022
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pazopanib hydrochloride, laboratory biomarker analysis and positron emission tomography in people with Adult Angiosarcoma and Recurrent Adult Soft Tissue Sarcoma, run by Fox Chase Cancer Center at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 37 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS Rate (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01462630.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.

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