Germ Cell TumorsPhase 2Pazotest-01NCT01743482
Pazopanib in Advanced and Cisplatin-resistant Germ Cell Tumors
A Phase 2 study testing Pazopanib in people with Germ Cell Tumors and Measurable Disease, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial summary
This is an open label, single arm, single center, phase 2 study with the use of the antiangiogenic multikinase inhibitor pazopanib in a population of patients with germ cell tumors who are not cured following first or subsequent chemotherapy lines for metastatic disease, followed by eventual surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Germ Cell Tumors, Measurable Disease
- What is being tested?
- Pazopanib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteItaly
- Study dates
- 17 May 2013to 27 Jul 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male gender.
- Confirmation of GCT histology based on pathologic review at Fondazione INT Milan.
- Unequivocal progression of measurable disease.
- A minimum of 2 and a maximum of 3 platinum-based chemotherapy lines for metastatic disease.
- First-line therapy should consist of at least 3 cycles of cisplatin-based chemotherapy.
- Prior single, tandem or triple high-dose chemotherapy course given as front-line or salvage therapy is allowed.
Who cannot join
- Failure to meet any of the above inclusion criteria.
- Concurrent treatment with other cytotoxic drugs or targeted therapies.
- Prior radiation therapy within 14 days of trial start.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Single-agent Pazopanib (Votrient®) for Patients With Relapsed or Refractory Germ-cell Tumors (GCT).
This is an open label, single arm, single center, phase 2 study with the use of the antiangiogenic multikinase inhibitor pazopanib in a population of patients with germ cell tumors who are not cured following first or subsequent chemotherapy lines for metastatic disease, followed by eventual surgery.
- Conditions
- Germ Cell Tumors, Measurable Disease
- Being tested
- Pazopanib
- Keywords
- Testicular Cancer, Germ Cell Tumors, Salvage Therapy, Pazopanib
- Medical subject headings
- Neoplasms, Germ Cell and Embryonal, Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PazopanibDrug
Also called Votrient
| Study group | Role | What they receive |
|---|---|---|
| Pazopanib | Experimental | Patients will receive pazopanib at the dose of 800 mg/day orally until disease progression or evidence of unacceptable toxicity/side effects. The study will be performed according to Simon's two-stage optimal design. Receives: Drug: Pazopanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
To evaluate the proportion of patients who are progression-free after 3 months of pazopanib.
Measured: 3-months
Secondary outcomes (3)
Safety and tolerability of pazopanib according to the Common Terminology Criteria for Adverse Events version 4.03
Measured: 3 months
Response Rate
A response rate will be considered as the sum of complete (CR) and partial responses (PR) according to the response evaluation criteria in solid tumors (RECIST), version 1.1
Measured: 3 months
Overall survival (OS)
OS time will be calculated as the interval from treatment start date to the date of death for any cause, with censoring at the date of last contact for patients alive. The Kaplan-Meier method will be used to estimate the OS curve.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study start17 May 2013
- Primary completion27 Jul 2016
- Study completion27 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Germ Cell TumorsStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Andrea Necchi, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743482
- Sponsor's protocol ID
- INT123/12
- Acronym
- Pazotest-01
- Status last verified
- May 2021
- First submitted
- 3 Dec 2012
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Single-agent Pazopanib (Votrient®) for Patients With Relapsed or Refractory Germ-cell Tumors (GCT).
- ClinicalTrials.gov ID
- NCT01743482
- Acronym / sponsor ID
- Pazotest-01 / INT123/12
- Conditions
- Germ Cell Tumors, Measurable Disease
- Keywords
- Testicular Cancer, Germ Cell Tumors, Salvage Therapy, Pazopanib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 17 May 2013 (actual)
- Primary completion
- 27 Jul 2016 (actual)
- Study completion
- 27 Jul 2016 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, single arm, single center, phase 2 study with the use of the antiangiogenic multikinase inhibitor pazopanib in a population of patients with germ cell tumors who are not cured following first or subsequent chemotherapy lines for metastatic disease, followed by eventual surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pazopanib | Experimental | Drug: PazopanibPatients will receive pazopanib at the dose of 800 mg/day orally until disease progression or evidence of unacceptable toxicity/side effects. The study will be performed according to Simon's two-stage optimal design. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male gender.
- Confirmation of GCT histology based on pathologic review at Fondazione INT Milan.
- Unequivocal progression of measurable disease.
- A minimum of 2 and a maximum of 3 platinum-based chemotherapy lines for metastatic disease.
- First-line therapy should consist of at least 3 cycles of cisplatin-based chemotherapy.
Key exclusion criteria (3 listed)
- Failure to meet any of the above inclusion criteria.
- Concurrent treatment with other cytotoxic drugs or targeted therapies.
- Prior radiation therapy within 14 days of trial start.
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 |
Primary outcome
Progression Free Survival
Time frame: 3-months
To evaluate the proportion of patients who are progression-free after 3 months of pazopanib.
3 secondary outcomes
Safety and tolerability of pazopanib according to the Common Terminology Criteria for Adverse Events version 4.03
Time frame: 3 months
Response Rate
Time frame: 3 months
Overall survival (OS)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Germ Cell Tumors and Measurable Disease, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
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 6 inclusion and 3 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 14 May 2021. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: 3-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 14 May 2021.