Advanced Solid TumorsPhase 1NCT01132625
Dose Escalation Study of AUY922 in Advanced Solid Malignancies in Japan
A Phase 1 study testing AUY922 in people with Advanced Solid Tumors, run by Novartis Pharmaceuticals at 2 sites in Japan.
Trial summary
This study will characterize the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of AUY922 in adult patients with advanced solid malignancies in Japan. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- AUY922
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesJapan
- Study dates
- Nov 2008to May 2012
- 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 advanced malignant solid tumors
- ECOG Performance Status of ≤ 2
- Patients must have the following laboratory values:
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Hemoglobin (Hgb) ≥ 8.5 g/dl, Platelets (plt) ≥ 100 x 109/L
- Potassium, Calcium, Magnesium, Phosphorus within normal limits or correctable with supplements
- AST/SGOT and ALT/SGPT ≤ 2.5 x Upper Limit of Normal (ULN)
- Serum bilirubin ≤ 1.5 x ULN, Serum albumin > 2.5g/dl, Serum creatinine≤ 1.5 x ULN or 24-hour clearance ≥ 50 ml/min
- Able to sign informed consent and to comply with the protocol
Who cannot join
- Patients with brain metastasis.
- Prior treatment with any HSP90 or HDAC inhibitor compound.
- Treatment with therapeutic doses of coumarin anticoagulants.
- Pregnant and lactating women.
- Severe and/or uncontrolled acute or chronic liver disease
- Severe and/or uncontrolled acute or chronic renal disease
Show all 11Show fewer
- Chronically significant heart disease
- History (or family history) of long QT syndrome. QTc ≥ 450 msec on screening ECG, ischemic heart disease, heart fail, ECG abnormalities, atrial fibrillation, atrial flutter or ventricular arrhythmias including ventricular tachycardia or Torsades de Pointes.
- Patients who are currently receiving treatment with any medication which has a relative risk or prolonging the QTcF interval or inducing Torsades de Pointes
- Patients with known disorders due to a deficiency in bilirubin glucuronidation (e.g Gilbert's syndrome).
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Novartis Investigative Site
Kashiwa, Chiba, 277-8577
Novartis Investigative Site
Sunto-gun, Shizuoka, 411-8777
About this study
Official title: A Japanese Phase I, Multi-center, Open-label, Study of AUY922 Administered Intravenously on a Once Weekly Schedule in Adult Patients With Advanced Solid Malignancies
This study will characterize the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of AUY922 in adult patients with advanced solid malignancies in Japan.
- Conditions
- Advanced Solid Tumors
- Being tested
- AUY922
- Keywords
- HSP90, molecular chaperone, advanced solid tumors, Japan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AUY922Drug
| Study group | Role | What they receive |
|---|---|---|
| AUY922 | Experimental | Not described Receives: Drug: AUY922 |
What is being measured
The primary outcome is the main question the study is designed to answer.
establish maximum tolerate dose (safety and tolerability)
Measured: about 3 years
Secondary outcomes (4)
Safety assessed by type, frequency and severity of adverse events
Measured: about 4 years
Efficacy assessed by RECIST
Measured: about 4 years
Pharmacokinetic assessed by Cmax, Tmax, AUC
Measured: about 3 years
Pharmacodynamic assessed by blood and tumor biomarkers at baseline and post AUY922
Measured: about 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startNov 2008
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 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
- NCT01132625
- Sponsor's protocol ID
- CAUY922A1101
- Status last verified
- Feb 2013
- First submitted
- 26 May 2010
- Last updated
- 9 Dec 2020
- Results posted
- No
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 Japanese Phase I, Multi-center, Open-label, Study of AUY922 Administered Intravenously on a Once Weekly Schedule in Adult Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT01132625
- Acronym / sponsor ID
- CAUY922A1101
- Conditions
- Advanced Solid Tumors
- Keywords
- HSP90, molecular chaperone, advanced solid tumors, Japan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 28 May 2010 (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 characterize the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of AUY922 in adult patients with advanced solid malignancies in Japan.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AUY922 | Experimental | Drug: AUY922 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with advanced malignant solid tumors
- ECOG Performance Status of ≤ 2
- Patients must have the following laboratory values:
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Hemoglobin (Hgb) ≥ 8.5 g/dl, Platelets (plt) ≥ 100 x 109/L
- Potassium, Calcium, Magnesium, Phosphorus within normal limits or correctable with supplements
Key exclusion criteria (11 listed)
- Patients with brain metastasis.
- Prior treatment with any HSP90 or HDAC inhibitor compound.
- Treatment with therapeutic doses of coumarin anticoagulants.
- Pregnant and lactating women.
- Severe and/or uncontrolled acute or chronic liver disease
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 |
|---|---|---|
| AUY922 | Drug | AUY922 |
Primary outcome
establish maximum tolerate dose (safety and tolerability)
Time frame: about 3 years
4 secondary outcomes
Safety assessed by type, frequency and severity of adverse events
Time frame: about 4 years
Efficacy assessed by RECIST
Time frame: about 4 years
Pharmacokinetic assessed by Cmax, Tmax, AUC
Time frame: about 3 years
Pharmacodynamic assessed by blood and tumor biomarkers at baseline and post AUY922
Time frame: about 4 years
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.
- Results for CAUY922A1101 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 AUY922 in people with Advanced 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 8 inclusion and 11 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.
What does the primary outcome measure?
establish maximum tolerate dose (safety and tolerability) (time frame: about 3 years). 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 Dec 2020.