Advanced Solid TumorsPhase 1NCT01064089
Dose Escalation of HSP990 in Japan/Korea
A Phase 1 study testing HSP990 in people with Advanced Solid Tumors, run by Novartis Pharmaceuticals at 2 sites in Japan.
Trial summary
This study is a phase I dose escalation, multi-center, open-label study of HSP990 administered orally once weekly in adult Japanese and Korea patients with advanced solid malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- HSP990
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesJapan
- Study dates
- Feb 2010to Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with advanced solid tumors (advanced cancer)
- Patient's disease must be evaluable using the RECIST criteria
- Patients must be 18 or older in Korea or 20 or older in Japan
- Patients must be relatively healthy as measured by their performance status
- Patients must have acceptable laboratory values as measured by blood tests
- Patients must be able to swallow capsules
- Patients must understand the study and give written permission to enter study
Who cannot join
- Patients cannot have brain tumors
- Patients cannot have had prior medicines that are similar to the study drug or an HDAC inhibitor medicine
- Patients must not be classified as a "poor or intermediate CYP2C9 metabolizer" as measured using a sample of their blood
- Patients must have recovered from all previous anti-cancer therapy
- Patients must have finished taking their previous anti-cancer therapy before entering study
- Patients must not have a severe disease at the time of study entry (for example: severe diarrhea, disease of the liver or kidney, other cancers, etc.)
- Patients must have relatively good heart function
- 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
Nagoya, Aichi-ken, 466-8560
About this study
Official title: A Phase I Dose Escalation, Multi-center, Open-label Study of HSP990 Administered Orally Once Weekly in Adult Japanese and Korea Patients With Advanced Solid Malignancies
This study is a phase I dose escalation, multi-center, open-label study of HSP990 administered orally once weekly in adult Japanese and Korea patients with advanced solid malignancies.
- Conditions
- Advanced Solid Tumors
- Being tested
- HSP990
- Keywords
- HSP990, HSP90, Japan/Korea, Phase I, advanced solid tumors, dose escalation, maximum tolerated dose, MTD, Japanese paatients, Korean patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSP990Drug
| Study group | Role | What they receive |
|---|---|---|
| HSP990 | Experimental | dose escalation Receives: Drug: HSP990 |
What is being measured
The primary outcome is the main question the study is designed to answer.
establish maximum tolerated dose (MTD)
Measured: 2.5 years
Secondary outcomes (4)
Safety by measuring occurrence of dose limiting toxicity (DLT) and other adverse events
Measured: 2.5 years
Efficacy by collecting data on response (complete response [CR], partial response [PR]) and stable disease (SD)
Measured: 2.5 years
Establishment of a pharmacokinetic profile by collecting information on parameters including but not limited to Cmax, Tmax, T1/2 and AUC in plasma samples
Measured: 2.5 years
Measurement of biomarkers for HSP90 pathway in blood and tissue
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionJan 2012
- Study completionJan 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
- 17 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
- NCT01064089
- Sponsor's protocol ID
- CHSP990A1101
- Status last verified
- Dec 2012
- First submitted
- 1 Feb 2010
- Last updated
- 8 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation, Multi-center, Open-label Study of HSP990 Administered Orally Once Weekly in Adult Japanese and Korea Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT01064089
- Acronym / sponsor ID
- CHSP990A1101
- Conditions
- Advanced Solid Tumors
- Keywords
- HSP990, HSP90, Japan/Korea, Phase I, advanced solid tumors, dose escalation, maximum tolerated dose, MTD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 8 Feb 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 is a phase I dose escalation, multi-center, open-label study of HSP990 administered orally once weekly in adult Japanese and Korea patients with advanced solid malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HSP990 | Experimental | Drug: HSP990dose escalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with advanced solid tumors (advanced cancer)
- Patient's disease must be evaluable using the RECIST criteria
- Patients must be 18 or older in Korea or 20 or older in Japan
- Patients must be relatively healthy as measured by their performance status
- Patients must have acceptable laboratory values as measured by blood tests
Key exclusion criteria (8 listed)
- Patients cannot have brain tumors
- Patients cannot have had prior medicines that are similar to the study drug or an HDAC inhibitor medicine
- Patients must not be classified as a "poor or intermediate CYP2C9 metabolizer" as measured using a sample of their blood
- Patients must have recovered from all previous anti-cancer therapy
- Patients must have finished taking their previous anti-cancer therapy before entering study
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 |
|---|---|---|
| HSP990 | Drug | HSP990 |
Primary outcome
establish maximum tolerated dose (MTD)
Time frame: 2.5 years
4 secondary outcomes
Safety by measuring occurrence of dose limiting toxicity (DLT) and other adverse events
Time frame: 2.5 years
Efficacy by collecting data on response (complete response [CR], partial response [PR]) and stable disease (SD)
Time frame: 2.5 years
Establishment of a pharmacokinetic profile by collecting information on parameters including but not limited to Cmax, Tmax, T1/2 and AUC in plasma samples
Time frame: 2.5 years
Measurement of biomarkers for HSP90 pathway in blood and tissue
Time frame: 2.5 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Results for CHSP990A1101 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
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RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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 HSP990 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 7 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: stopped early, as of the sponsor's last update on 8 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 was stopped early. Results are not available in the source record.
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 tolerated dose (MTD) (time frame: 2.5 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 8 Dec 2020.