SarcomaPhase 2NCT02207309
Pazopanib Maintenance Phase II
A Phase 2 study testing Pazopanib in people with Sarcoma, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
This trial compares pazopanib to placebo as maintenance treatment over 2 years in patients with retroperitoneal and visceral high-risk soft tissue sarcomas after multimodal treatment including prior neo- and/or adjuvant doxorubicin / ifosfamide chemotherapy with regional hyperthermia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- Pazopanib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteGermany
- Study dates
- 22 Jun 2015to 29 Jul 2016
- 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 prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up
- Patients must have histological evidence of high-grade soft tissue sarcoma (grade 2 - 3) according to the FNLCC grading system, tumor size ≥ 5 cm and deep localization with regard to the superficial fascia, excluding the following tumor types:
- Embryonal rhabdomyosarcoma
- Chondrosarcoma (excluding extraskeletal myxoid chondrosarcoma)
- Osteosarcoma (excluding extraskeletal osteosarcoma)
- Ewing tumors / primitive neuroectodermal tumor (PNET)
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- Gastro-intestinal stromal tumors (GIST)
- Dermatofibrosarcoma protuberans
- Patients who had undergone previous surgery with inadequate margins (tumour-free margins ≤1 cm or margins contaminated) are eligible if thermochemotherapy has been started within 8 weeks after surgery
- Unstained slides and ideally tumour blocks must be available for histological central review
- Completed 4 to 8 cycles of thermochemotherapy with doxorubicin and ifosfamide at least 21 days but no more than 42 days prior to study entry
- No evidence of disease following completion of first-line thermochemotherapy and within ≤ 21 days of study entry
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- No other prior chemotherapy except thermochemotherapy with doxorubicin and ifosfamide
- Adequate organ system function
Who cannot join
- No prior or concurrent second primary malignant tumors (except adequately treated in situ carcinoma of cervix, or basal cell carcinoma)
- No symptomatic or known Central nervous system (CNS) metastases at baseline
- Clinically significant gastrointestinal 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
- Inflammatory bowel disease (e.g. ulcerative colitis, Chrohn's disease), or other gastrointestinal conditions with increased risk of perforation
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- History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.
- 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
- 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) (See Appendix D for description)
- Poorly controlled hypertension (SBP of ≤ 150 mmHg or DBP of ≤95 mmHg is acceptable provided that BP will be treated and monitored at least weekly. The goal is to attain controlled hypertension within 4 weeks of start of IMP which is defined as grade ≤1 hypertension CTCAE Version 4.0)
- NYHA II at Screening for Patients > 65 years
- History of 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 treated with therapeutic anti-coagulating agents 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.
- Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage Note: Lesions infiltrating major pulmonary vessels (contiguous tumour and vessels) are excluded; however, the presence of a tumor that is touching, but not infiltrating (abutting) the vessels is acceptable (CT with contrast is strongly recommended to evaluate such lesions).
- Large protruding endobronchial lesions in the main or lobar bronchi are excluded; however, endobronchial lesions in the segmented bronchi are allowed.
- Lesions extensively infiltrating the main or lobar bronchi are excluded; however, minor infiltrations in the wall of the bronchi are allowed.
- Recent hemoptysis (≥½ teaspoon of red blood within 8 weeks before first dose of study drug).
- 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.
- Treatment with any of the following anti-cancer therapies:
- radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib 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
- Administration of any non-oncologic investigational drug within 30 days or 5 half lives whichever is longer prior to receiving the first dose of study treatment
- Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia
Trial locations and contacts
1 site in 1 country.
Germany1 site
Ludwig-Maximilians University of Munich, Klinikum Großhadern
Munich, Bavaria, 81377
About this study
Official title: A Randomized, Double Blind, Phase II Trial of Pazopanib Versus Placebo as Maintenance Therapy in Patients With Retroperitoneal and Visceral High-risk Soft Tissue Sarcomas Following Prior Neo- and/or Adjuvant Doxorubicin / Ifosfamide Chemotherapy With Regional Hyperthermia
This trial compares pazopanib to placebo as maintenance treatment over 2 years in patients with retroperitoneal and visceral high-risk soft tissue sarcomas after multimodal treatment including prior neo- and/or adjuvant doxorubicin / ifosfamide chemotherapy with regional hyperthermia.
- Conditions
- Sarcoma
- Being tested
- Pazopanib, Placebo (for Pazopanib)
- Keywords
- high-risk soft tissue sarcoma, pazopanib, retroperitoneal soft tissue sarcoma, visceral soft tissue sarcoma, votrient
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PazopanibDrug
Also called Votrient
Placebo (for Pazopanib)Drug
| Study group | Role | What they receive |
|---|---|---|
| Pazopanib | Active comparator | 800mg, oral, 24 months Receives: Drug: Pazopanib |
| Placebo | Placebo comparator | 800mg, oral, 24 months Receives: Drug: Placebo (for Pazopanib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
The study could not be evaluated. Only one patient was included.
Measured: Study Start Dat: June 22, 2015; Study Completion Date: July 29, 2016 ; an approximate study duration of 13 months
Secondary outcomes (1)
Overall Survival (OS)
The study could not be evaluated. Only one patient was included.
Measured: Study Start Dat: June 22, 2015; Study Completion Date: July 29, 2016 ; an approximate study duration of 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study start22 Jun 2015
- Primary completion29 Jul 2016
- Study completion29 Jul 2016
Why it stopped: poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Lindner, Ludwig-Maximilians - University of Munich
- Investigators
- Lars Lindner, MD, PhD, Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02207309
- Sponsor's protocol ID
- NPM001
- Other IDs
- 2013-000522-58
- Status last verified
- Feb 2024
- First submitted
- 31 Jul 2014
- Last updated
- 9 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Phase II Trial of Pazopanib Versus Placebo as Maintenance Therapy in Patients With Retroperitoneal and Visceral High-risk Soft Tissue Sarcomas Following Prior Neo- and/or Adjuvant Doxorubicin / Ifosfamide Chemotherapy With Regional Hyperthermia
- ClinicalTrials.gov ID
- NCT02207309
- Acronym / sponsor ID
- NPM001
- Conditions
- Sarcoma
- Keywords
- high-risk soft tissue sarcoma, pazopanib, retroperitoneal soft tissue sarcoma, visceral soft tissue sarcoma, votrient
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- 22 Jun 2015 (actual)
- Primary completion
- 29 Jul 2016 (actual)
- Study completion
- 29 Jul 2016 (actual)
- First posted
- 4 Aug 2014 (estimated)
- Results
- Posted 9 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial compares pazopanib to placebo as maintenance treatment over 2 years in patients with retroperitoneal and visceral high-risk soft tissue sarcomas after multimodal treatment including prior neo- and/or adjuvant doxorubicin / ifosfamide chemotherapy with regional hyperthermia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pazopanib | Active comparator | Drug: Pazopanib800mg, oral, 24 months |
| Placebo | Placebo comparator | Drug: Placebo (for Pazopanib)800mg, oral, 24 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up
- Patients must have histological evidence of high-grade soft tissue sarcoma (grade 2 - 3) according to the FNLCC grading system, tumor size ≥ 5 cm and deep localization with regard to the superficial fascia, excluding the following tumor types:
- Patients who had undergone previous surgery with inadequate margins (tumour-free margins ≤1 cm or margins contaminated) are eligible if thermochemotherapy has been started within 8 weeks after surgery
- Unstained slides and ideally tumour blocks must be available for histological central review
- Completed 4 to 8 cycles of thermochemotherapy with doxorubicin and ifosfamide at least 21 days but no more than 42 days prior to study entry
Key exclusion criteria (34 listed)
- No prior or concurrent second primary malignant tumors (except adequately treated in situ carcinoma of cervix, or basal cell carcinoma)
- No symptomatic or known Central nervous system (CNS) metastases at baseline
- Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
- Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
- Corrected QT interval (QTc) > 480 msecs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PazopanibAlso: Votrient | Drug | Pazopanib |
| Placebo (for Pazopanib) | Drug | Placebo |
Primary outcome
Progression-free Survival (PFS)
Time frame: Study Start Dat: June 22, 2015; Study Completion Date: July 29, 2016 ; an approximate study duration of 13 months
The study could not be evaluated. Only one patient was included.
1 secondary outcome
Overall Survival (OS)
Time frame: Study Start Dat: June 22, 2015; Study Completion Date: July 29, 2016 ; an approximate study duration of 13 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Lindner, MD, PhD principal investigator
Ludwig-Maximilians - University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pazopanib in people with Sarcoma, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 15 inclusion and 34 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: stopped early, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. Some participants in this study may receive a placebo. 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 9 Aug 2024). 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?
Progression-free Survival (PFS) (time frame: Study Start Dat: June 22, 2015; Study Completion Date: July 29, 2016 ; an approximate study duration of 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2024.