Advanced Solid MalignanciesPhase 1NCT00879905
A Study of HSP990 Administered by Mouth in Adult Patients With Advanced Solid Tumors
A Phase 1 study testing HSP990 in people with Advanced Solid Malignancies, run by Novartis Pharmaceuticals at 3 sites in 3 countries.
Trial summary
This study will study the safety, tolerability and metabolism of a drug called HSP990 when given by mouth once a week or twice weekly to subjects with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Malignancies
- What is being tested?
- HSP990
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 3 sitesin 3 countries
- Study dates
- May 2009to Jul 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 histologically confirmed, advanced malignant solid tumors whose disease has progressed on standard therapy or for whom no standard therapy exists
- All patients must have at least one measurable lesion as defined by RECIST. Irradiated lesions are only evaluable for disease progression
- All patients must have documented progressive disease before entering the study
- Age ≥ 18 years
- World Health Organization (WHO) Performance Status ≤ 2
- Life expectancy of ≥ 12 weeks
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- Patients must have the certain laboratory values
- Patients able and willing to swallow capsules
- Ability to understand the patient information and informed consent form and comply with the protocol
- Signed and dated written informed consent is available
- Only for patients enrolled at MTD: willing to provide a fresh pre-dose and post-dose tumor biopsy.
Who cannot join
- Patients with present or history of CNS metastasis.
- Prior treatment with any Hsp90 or HDAC inhibitor compound.
- Patients who have not recovered from side effects of previous systemic anticancer therapy to < CTCAE Grade 2 prior to the first dose
- Patients identified to be "poor or intermediate CYP2C9 metabolizers"
- Patients who received systemic anti-cancer treatment prior to the first dose of HSP990 within the following time frames:
- Patients who have received cyclical chemotherapy within a period of time that is shorter than the cycle length used for that treatment (e.g., 6 weeks for nitrosourea, mitomycin-C) prior to starting study drug or who have not recovered from the side effects of such therapy
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- Patients who have received biologic therapy (e.g., antibodies) within a period of time that is ≤ 4 weeks prior to starting study drug or who have not recovered from the side effects of such therapy
- Patients who have been treated with a continuous or intermittent small molecule therapeutic within a period of time that is ≤ 5 t1/2 or ≤ 4 weeks (whichever is shorter) prior to starting study drug or who have not recovered from the side effects of such therapy
- Patients who have received any other investigational agents within a period of time that is ≤ 5 t1/2 or less than the cycle length used for that treatment or ≤ 4 weeks (whichever is shorter) prior to starting study drug or who have not recovered from the side effects of such therapy
- Patients who have received wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy.
- Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
- Treatment with therapeutic doses of sodium warfarin (Coumadin).
- Patients using medications that are CYP2C9 inhibitors and/or medications known to have QT prolongation effect and cannot be switched or discontinued to an alternative drug prior to commencing HSP990 dosing.
- Unresolved diarrhea ≥ CTCAE grade 2
- Patients who do not have either an archival tumor sample available or readily obtainable in the course of the study or are unwilling to have a fresh tumor sample collected at baseline.
- Pregnant or lactating women.
- Fertile women of childbearing potential (WCBP) not using adequate contraception (abstinence, oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile). Male patients whose partners are WCBP, not using adequate contraception.
- Acute or chronic liver disease.
- Acute or chronic renal disease.
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of HSP990
- Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol.
- Known diagnosis of HIV infection (HIV testing is not mandatory).
- Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
- Cardiac exclusion criteria:
- History (or family history) of long QT syndrome.
- Mean QTcF ≥ 480 msec on screening ECG
- History of clinically manifest ischemic heart disease including myocardial infarction, or unstable angina ≤ 3 months prior to study start.
- Left ventricular (LV) dysfunction (LVEF ≤ 45%) by MUGA or ECHO
- Clinically significant ECG abnormalities including one or more of the following: left bundle branch block (LBBB), right bundle branch block (RBBB) with left anterior hemiblock (LAHB), or 3rd degree AV block.
- History or presence of atrial fibrillation, atrial flutter or ventricular arrhythmias including ventricular tachycardia or Torsades de Pointes.
- Clinically significant resting bradycardia (< 50 beats per minute).
- Patients who are currently receiving treatment with any medication which has a relative risk or prolonging the QTcF interval or inducing Torsades de Pointes (as listed in Post-text supplement 2) and cannot be switched or discontinued to an alternative drug prior to commencing HSP990 dosing.
- Obligate use of a cardiac pacemaker.
- Other clinically significant heart disease (e.g., congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Phase I Dose Escalation, Multi-center, Open-label Study of HSP990 Administered Orally in Adult Patients With Advanced Solid Malignancies
This study will study the safety, tolerability and metabolism of a drug called HSP990 when given by mouth once a week or twice weekly to subjects with advanced solid tumors.
- Conditions
- Advanced Solid Malignancies
- Being tested
- HSP990
- Keywords
- Phase I, Adults, HSP990, Advanced Solid Tumors, Hsp90 inhibitor, Cancer
- Medical subject headings
- Neoplasms
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 |
|---|---|---|
| once weekly dosing schedule | Experimental | Not described Receives: Drug: HSP990 |
| twice weekly dosing schedule | Experimental | Not described Receives: Drug: HSP990 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose of HSP990 in patients treated once weekly or twice weekly
Measured: At the end of the dose escalation phase of the study
Secondary outcomes (3)
True DLT rate
Measured: At the end of the 1st 4 weeks of treatment
Preliminary Efficacy
Measured: Every 2 months (or 8 weeks, which equals 2 treatment cycles)
Drug metabolism in Humans, PK, PD
Measured: every 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid MalignanciesStudies 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
- 64 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
- NCT00879905
- Sponsor's protocol ID
- CHSP990A2101
- Other IDs
- 2008-006440-19, 2008
- Status last verified
- Oct 2012
- First submitted
- 9 Apr 2009
- 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 in Adult Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT00879905
- Acronym / sponsor ID
- CHSP990A2101
- Conditions
- Advanced Solid Malignancies
- Keywords
- Phase I, Adults, HSP990, Advanced Solid Tumors, Hsp90 inhibitor, Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 13 Apr 2009 (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 study the safety, tolerability and metabolism of a drug called HSP990 when given by mouth once a week or twice weekly to subjects with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| once weekly dosing schedule | Experimental | Drug: HSP990 |
| twice weekly dosing schedule | Experimental | Drug: HSP990 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with histologically confirmed, advanced malignant solid tumors whose disease has progressed on standard therapy or for whom no standard therapy exists
- All patients must have at least one measurable lesion as defined by RECIST. Irradiated lesions are only evaluable for disease progression
- All patients must have documented progressive disease before entering the study
- Age ≥ 18 years
- World Health Organization (WHO) Performance Status ≤ 2
Key exclusion criteria (35 listed)
- Patients with present or history of CNS metastasis.
- Prior treatment with any Hsp90 or HDAC inhibitor compound.
- Patients who have not recovered from side effects of previous systemic anticancer therapy to < CTCAE Grade 2 prior to the first dose
- Patients identified to be "poor or intermediate CYP2C9 metabolizers"
- Patients who received systemic anti-cancer treatment prior to the first dose of HSP990 within the following time frames:
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 | once weekly dosing schedule, twice weekly dosing schedule |
Primary outcome
Maximum Tolerated Dose of HSP990 in patients treated once weekly or twice weekly
Time frame: At the end of the dose escalation phase of the study
3 secondary outcomes
True DLT rate
Time frame: At the end of the 1st 4 weeks of treatment
Preliminary Efficacy
Time frame: Every 2 months (or 8 weeks, which equals 2 treatment cycles)
Drug metabolism in Humans, PK, PD
Time frame: every 4 weeks
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 8 Dec 2020.
- Results for CHSP990A2101 can be found on the Novartis Clinical Trials Results WebsiteLink provided by the sponsor.
Related trials for Advanced Solid Malignancies
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
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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
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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
3 sites in 3 countries: 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 Malignancies, run by Novartis Pharmaceuticals at 3 sites in 3 countries.
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 11 inclusion and 35 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 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 3 sites in Canada, France, Spain. 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?
Maximum Tolerated Dose of HSP990 in patients treated once weekly or twice weekly (time frame: At the end of the dose escalation phase of the study). 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.