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Phase 2 N=29 Treatment

Pazopanib Hydrochloride in Treating Patients With Advanced Angiosarcoma

Adult Angiosarcoma · Recurrent Adult Soft Tissue Sarcoma · Stage III Adult Soft Tissue Sarcoma · Stage IV Adult Soft Tissue Sarcoma

Enrolled (actual)
29
Serious AEs
44.8%
Results posted
Aug 2022
Primary outcome: Primary: PFS Rate — 54.6 percentage of patients

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
pazopanib hydrochloride (Drug); laboratory biomarker analysis (Other); positron emission tomography (Procedure); computed tomography (Procedure); fludeoxyglucose F 18 (Radiation)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Fox Chase Cancer Center
Primary completion
Jan 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
PFS Rate
54.6
PRIMARY
Response Rate Defined as CR
PRIMARY
Response Rate Defined as Partial Response (PR)
1
SECONDARY
Overall Survival of Patients Treated With Pazopanib Hydrochloride
69.8
SECONDARY
Evaluation of Toxicity of Pazopanib Hydrochloride in This Patient Population
189
SECONDARY
Ability of [F-18] FDG PET/CT as an Imaging Agent in Predicting Efficacy or Early Response as Compared With CT Imaging

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.

Eligibility Criteria

Inclusion Criteria

  • 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 = = 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%
  • 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) = 1.5 mg/dL: calculated creatinine clearance (ClCR) > 50 mL/min
  • Urine Protein to Creatinine Ratio (UPC) = 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 = 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

Exclusion Criteria

  • 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 CN
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01462630). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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