A Phase 2 interventional study of Pazopanib + Paclitaxel in Angiosarcoma, sponsored by Heidelberg University. Terminated at 10 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-22.
Sponsored by Heidelberg University · Phase 2, Interventional, and Treatment
Open-label phase II trial investigating the efficacy and safety of the investigational combination of pazopanib and paclitaxel.
Open-label phase II trial investigating the efficacy and safety of the investigational combination of pazopanib and paclitaxel.This multi-center, open-label, prospective, single arm phase II study was designed to evaluate the clinical efficacy and safety of the experimental combination of pazopanib with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.The safety evaluations (physical examination, laboratory checks as defined in protocol, toxicity/adverse event assessment according Eastern Cooperative Oncology Group version 4.0) are scheduled every cycle at day 1, 8, 15 and 29 (= day 1 of the next cycle).
99 studies on the registry are indexed under Hemangiosarcoma; 16 are open to participants now.
This study's enrollment of 26 is below the median of 64 across 83 interventional studies indexed under Hemangiosarcoma.
Browse Hemangiosarcoma studies →Heidelberg University is the lead sponsor of 287 studies on the registry; 19 are open to participants now.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Paclitaxel administered every 28 days at day 1, day 8 and day 15 as a 2h intravenous infusion in a dose of 70mg/m2 in combination with pazopanib in a daily oral dose of 800mg (2x400mg)
Drug: Pazopanib + Paclitaxel
Drug pages: Pazopanib · Paclitaxel
pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.
Rate of Progression-free Survival
The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions.
Time frame: 6 Month
Rate of Progression-free Survival, Subgroup 1 Analysis
Rate of progression-free survival for Subgroup 1 categorizing the 12 participants who showed PFS after 6 months into cutaneous angiosarcoma versus visceral angiosarcoma The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions.
Time frame: 6 months
Rate of Progression-free Survival, Subgroup 2 Analysis
Rate of progression-free survival for Subgroup 1 categorizing the 12 participants who showed PFS after 6 months into primary angiosarcoma versus secondary angiosarcoma. The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions.
Time frame: 6 months
Overall Survival
Survival time of patient from start of treatment until death
Time frame: from start of treatment until death within study's actual observation time for OS (22 months).
Overall Survival, Subgroup 1 Analysis
Survival time of patients from start of treatment until death, Subgroup 1 categorizing 26 overall participants into 18 cutaneous angiosarcoma versus 8 visceral angiosarcomas
Time frame: from start of treatment until death within study's actual observation time for OS (22 months)
Overall Survival, Subgroup 2 Analysis
Survival time of patients from start of treatment until death, Subgroup 2 categorizing 26 overall participants into 13 primary cutaneous angiosarcoma versus 13 secondary angiosarcomas
Time frame: from start of treatment until death within study's actual observation time for OS (22 months)
Response Rate (RR)
Measurable skin lesions will be evaluated clinically and documented photographically, all other target lesions will be evaluated radiologically by CT or MRI according to RECIST Version 1.1. RR is given as 'Best overall response" BOR" defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies
Time frame: determined every 8 weeks during first 6 month then every 12 weeks in follow-up period until progression or death or end of overall study observation period (22 months), then evaluated as BOR
Response Rate (RR), Subgroup1 Analysis
Measurable skin lesions will be evaluated clinically and documented photographically, all other target lesions will be evaluated radiologically by CT or MRI according to RECIST Version 1.1. RR is given as 'Best overall response" BOR" defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies for Subgroup 1 which is the analysis of cutaneous angiosarcoma versus visceral angiosarcoma
Time frame: determined every 8 weeks during first 6 month then every 12 weeks in follow-up period until progression or death or end of overall study observation period (22 months), then evaluated as BOR
Response Rate (RR), Subgroup 2 Analysis
Measurable skin lesions will be evaluated clinically and documented photographically, all other target lesions will be evaluated radiologically by CT or MRI according to RECIST Version 1.1. RR is given as 'Best overall response" BOR" defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies for Subgroup 2 which is the analysis of primary angiosarcoma versus secondary angiosarcoma
Time frame: determined every 8 weeks during first 6 month then every 12 weeks in follow-up period until progression or death or end of overall study observation period (22 months), then evaluated as BOR
Adverse Events and Serious Adverse Events
Number of patients in which adverse events occur during treatment according to Common Toxicity Criteria for Adverse Effects, Version 4.0
Time frame: 30 days after EOS of last patient or end of overall study observation period (22 months)
| Milestone | Pazopanib + Paclitaxel |
|---|---|
| Started | 26 |
| Completed | 25 |
| Not completed | 1 |
The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions.
| Participants | Pazopanib + Paclitaxel |
|---|---|
| Rate of Progression-free Survival | 12 |
Rate of progression-free survival for Subgroup 1 categorizing the 12 participants who showed PFS after 6 months into cutaneous angiosarcoma versus visceral angiosarcoma The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions.
| Participants | Pazopanib + Paclitaxel |
|---|---|
| cutaneous angiosarcoma | 11 |
| visceral angiosarcoma | 1 |
Rate of progression-free survival for Subgroup 1 categorizing the 12 participants who showed PFS after 6 months into primary angiosarcoma versus secondary angiosarcoma. The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions.
| Participants | Pazopanib + Paclitaxel |
|---|---|
| primary angiosarcoma | 6 |
| secondary angiosarcoma | 6 |
Survival time of patient from start of treatment until death
| months | Pazopanib + Paclitaxel |
|---|---|
| Overall Survival | 21.6 (20.5 to NA) |
Survival time of patients from start of treatment until death, Subgroup 1 categorizing 26 overall participants into 18 cutaneous angiosarcoma versus 8 visceral angiosarcomas
| months | Pazopanib + Paclitaxel |
|---|---|
| cutaneous angiosarcoma | 21.6 (10.0 to 21.6) |
| visceral angiosaroma | 20.5 (2.8 to NA) |
Survival time of patients from start of treatment until death, Subgroup 2 categorizing 26 overall participants into 13 primary cutaneous angiosarcoma versus 13 secondary angiosarcomas
| months | Pazopanib + Paclitaxel |
|---|---|
| primary angiosarcoma | 20.5 (10.0 to NA) |
| secondary angiosarcoma | 21.6 (NA to NA) |
Measurable skin lesions will be evaluated clinically and documented photographically, all other target lesions will be evaluated radiologically by CT or MRI according to RECIST Version 1.1. RR is given as 'Best overall response" BOR" defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies
| Participants | Pazopanib + Paclitaxel |
|---|---|
| CR | 2 |
| PR | 7 |
| SD | 6 |
| PD | 10 |
| NE | 1 |
Measurable skin lesions will be evaluated clinically and documented photographically, all other target lesions will be evaluated radiologically by CT or MRI according to RECIST Version 1.1. RR is given as 'Best overall response" BOR" defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies for Subgroup 1 which is the analysis of cutaneous angiosarcoma versus visceral angiosarcoma
| Participants | Pazopanib + Paclitaxel |
|---|---|
| cutaneous angiosarcoma — CR | 2 |
| cutaneous angiosarcoma — PR | 6 |
| cutaneous angiosarcoma — SD | 4 |
| cutaneous angiosarcoma — PD | 6 |
| cutaneous angiosarcoma — NE | 0 |
| visceral angiosarcoma — CR | 0 |
| visceral angiosarcoma — PR | 1 |
| visceral angiosarcoma — SD | 2 |
| visceral angiosarcoma — PD | 4 |
| visceral angiosarcoma — NE | 1 |
Measurable skin lesions will be evaluated clinically and documented photographically, all other target lesions will be evaluated radiologically by CT or MRI according to RECIST Version 1.1. RR is given as 'Best overall response" BOR" defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies for Subgroup 2 which is the analysis of primary angiosarcoma versus secondary angiosarcoma
| Participants | Pazopanib + Paclitaxel |
|---|---|
| primary angiosarcoma — CR | 0 |
| primary angiosarcoma — PR | 5 |
| primary angiosarcoma — SD | 3 |
| primary angiosarcoma — PD | 5 |
| primary angiosarcoma — NE | 0 |
| secondary angiosarcoma — CR | 2 |
| secondary angiosarcoma — PR | 2 |
| secondary angiosarcoma — SD | 3 |
| secondary angiosarcoma — PD | 5 |
| secondary angiosarcoma — NE | 1 |
Number of patients in which adverse events occur during treatment according to Common Toxicity Criteria for Adverse Effects, Version 4.0
| Participants | Pazopanib + Paclitaxel |
|---|---|
| Patients with AEs | 25 |
| Patients with SAEs | 10 |
Collected over Adverse Events were collected over the study observation period which was 22 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pazopanib + Paclitaxel | 1/26 (3.8%) | 10/26 (38.5%) | 25/26 (96.2%) |
| Event | Pazopanib + Paclitaxel |
|---|---|
| Reduced general conditionGeneral disorders | 2/26 |
| Lumbar spinal stenosisNervous system disorders | 1/26 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 1/26 |
| PalpitationCardiac disorders | 1/26 |
| ErysipelasInfections and infestations | 1/26 |
| TachycardiaCardiac disorders | 1/26 |
| Gastrointestinal bleedingGastrointestinal disorders | 1/26 |
| Fever of unknown originGeneral disorders | 1/26 |
| ALT increasedHepatobiliary disorders | 1/26 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 1/26 |
| Event | Pazopanib + Paclitaxel |
|---|---|
| DiarrheaGastrointestinal disorders | 16/26 |
| HypertensionVascular disorders | 12/26 |
| FatigueGeneral disorders | 12/26 |
| DysgeusiaNervous system disorders | 11/26 |
| AlopeciaSkin and subcutaneous tissue disorders | 8/26 |
| NeuropathiaNervous system disorders | 8/26 |
| NauseaGastrointestinal disorders | 8/26 |
| Oedema legGeneral disorders | 7/26 |
| LeukopeniaBlood and lymphatic system disorders | 6/26 |
| StomatitisGastrointestinal disorders | 6/26 |
| Age, Continuous(years) | Pazopanib + Paclitaxel |
|---|---|
| Mean | 57.8 ± 13.5 |
| Sex: Female, Male(Participants) | Pazopanib + Paclitaxel |
|---|---|
| Female | 23 |
| Male | 3 |
| Race and Ethnicity Not Collected(Participants) | Pazopanib + Paclitaxel |
|---|
| Subgroup 1 for Analyses(Participants) | Pazopanib + Paclitaxel |
|---|---|
| cutaneous angiosarcoma | 18 |
| visceral angiosarcoma | 8 |
| Subgroup 2 for Analyses(Participants) | Pazopanib + Paclitaxel |
|---|---|
| primary angiosarcoma | 13 |
| secondary angiosarcoma | 13 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is terminated, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Pazopanib · Paclitaxel