Advanced or Recurrent Solid TumorsPhase 1NCT01285453
Safety and Tolerability of ASA404 Administered in Combination With Docetaxel in Japanese Patients With Solid Tumors
A Phase 1 study testing vadimezan in people with Advanced or Recurrent Solid Tumors, run by Novartis Pharmaceuticals at 2 sites in Japan.
Trial summary
This study will assess the tolerability of combination therapy with ASA404 and docetaxel in Japanese patients with advanced or recurrent solid tumors. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced or Recurrent Solid Tumors
- What is being tested?
- vadimezan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesJapan
- Study dates
- Mar 2009to Dec 2009
- Phase
- Phase 1
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with confirmed solid tumors whose disease has progressed or recurred after treatment at lease one therapy, except docetaxel
- WHO Performance Status of 0-1
Who cannot join
- Patients having symptomatic CNS tumor/metastasis and requiring treatment
- Patients who have received prior therapy with ASA404 or other vascular disrupting agents
- Patients with systolic BP > 160mmHg and/or diastolic BP > 90mmHg
- Patients with fluid retention
- Patients with any one of cardiotoxicities
- Concomitant use of drugs with a risk of prolonging the QT interval
- Known allergy or hypersensitivity to taxane or polysorbate 80
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Safety, Tolerability Study of Intravenous ASA404 Administered in Combination With Docetaxel in Japanese Patients With Advanced or Recurrent Solid Tumors
This study will assess the tolerability of combination therapy with ASA404 and docetaxel in Japanese patients with advanced or recurrent solid tumors.
- Conditions
- Advanced or Recurrent Solid Tumors
- Being tested
- vadimezan
- Keywords
- ASA404,, vadimezan,, docetaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vadimezanDrug
Also called ASA404
| Study group | Role | What they receive |
|---|---|---|
| ASA404 | Experimental | Not described Receives: Drug: vadimezan |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2011 (estimated)
- Study startMar 2009
- Primary completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced or Recurrent Solid TumorsStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285453
- Sponsor's protocol ID
- CASA404A1102
- Status last verified
- Nov 2012
- First submitted
- 26 Jan 2011
- Last updated
- 9 Dec 2020
- Results posted
- No
Publications
Daga H, Hida T, Ishikawa S, Shimizu J, Tokunaga S, Horio Y, Kobayashi K, Takeda K. The safety and tolerability of intravenous ASA404 when administered in combination with docetaxel (60 or 75 mg/m(2)) in Japanese patients with advanced or recurrent solid tumors. Jpn J Clin Oncol. 2011 Sep;41(9):1067-73. doi: 10.1093/jjco/hyr110. Epub 2011 Aug 10.
PubMed 21835825
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety, Tolerability Study of Intravenous ASA404 Administered in Combination With Docetaxel in Japanese Patients With Advanced or Recurrent Solid Tumors
- ClinicalTrials.gov ID
- NCT01285453
- Acronym / sponsor ID
- CASA404A1102
- Conditions
- Advanced or Recurrent Solid Tumors
- Keywords
- ASA404,, vadimezan,, docetaxel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Dec 2009 (actual)
- First posted
- 28 Jan 2011 (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 study will assess the tolerability of combination therapy with ASA404 and docetaxel in Japanese patients with advanced or recurrent solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASA404 | Experimental | Drug: vadimezan |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with confirmed solid tumors whose disease has progressed or recurred after treatment at lease one therapy, except docetaxel
- WHO Performance Status of 0-1
Key exclusion criteria (8 listed)
- Patients having symptomatic CNS tumor/metastasis and requiring treatment
- Patients who have received prior therapy with ASA404 or other vascular disrupting agents
- Patients with systolic BP > 160mmHg and/or diastolic BP > 90mmHg
- Patients with fluid retention
- Patients with any one of cardiotoxicities
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 |
|---|---|---|
| vadimezanAlso: ASA404 | Drug | ASA404 |
Primary outcome
Not reported in the source record.
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 9 Dec 2020.
- Derived from this study: PubMed 21835825Daga H, Hida T, Ishikawa S, Shimizu J, Tokunaga S, Horio Y, Kobayashi K, Takeda K. The safety and tolerability of intravenous ASA404 when administered in combination with docetaxel (60 or 75 mg/m(2)) in Japanese patients with advanced or recurrent solid tumors. Jpn J Clin Oncol. 2011 Sep;41(9):1067-73. doi: 10.1093/jjco/hyr110. Epub 2011 Aug 10.
- Results for CASA404A1102 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing vadimezan in people with Advanced or Recurrent Solid Tumors, run by Novartis Pharmaceuticals at 2 sites in Japan.
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 2 inclusion and 8 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 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01285453, which also lists 1 linked publication.
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 Dec 2020.