CancerPhase 1NCT00796484
Safety Study of Pharmacokinetics of XL888 in Adults With Solid Tumors
A Phase 1 study testing XL888 in people with Cancer, run by Exelixis at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of XL888 in subjects with solid tumors. XL888 is a potent and selective inhibitor of HSP90, a key component of a molecular chaperone complex that promotes the conformational maturation and stabilization of diverse client proteins. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- XL888
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2008to Nov 2010
- 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
- Subject has a histologically-confirmed tumor that is metastatic or unresectable and is no longer responding to therapies known to prolong survival or to other standard therapies, or has disease for which no effective therapy exists.
- For subjects enrolling in the maximum tolerated dose expansion cohorts:
- Subject has documented evidence of Her2-overexpressing tumor; OR
- Subject has NSCLC that has progressed after a prior response to erlotinib or gefitinib; OR
- Subject has histologically-confirmed, metastatic melanoma.
- For subjects in the expansion cohorts A and C: tumor tissue must be accessible for biopsy and subjects must be willing to undergo tumor biopsy.
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- The subject is ≥ 18 years old.
- The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- The subject's weight is ≥ 40 kg.
- The subject has adequate organ and marrow function.
- The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document.
- Sexually active subjects (male and female) must use accepted methods of contraception during the course of the study and for 3 months after the last dose of XL888.
- Female subjects of childbearing potential must have a negative pregnancy test at screening.
Who cannot join
- The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic therapy (cytokines, antibodies) within 3 weeks (or nitrosoureas or mitomycin C within 6 weeks) before the first dose of XL888.
- The subject has received prior treatment with a small molecule kinase inhibitor (including an investigational kinase inhibitor) or hormonal therapy within 14 days before the first dose of XL888.
- The subject has received any other type of investigational agent within 28 days before the first dose of study treatment.
- The subject has a previously-identified allergy or hypersensitivity to components of the study treatment formulation.
- The subject has not recovered from clinically-meaningful toxicity due to prior therapy.
- The subject has been previously treated with an HSP90 inhibitor
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- The subject has untreated or uncontrolled brain metastases or evidence of leptomeningeal involvement of disease.
- The subject is currently receiving anticoagulation with therapeutic dose of warfarin.
- The subject has uncontrolled intercurrent illness including, but not limited to: ongoing or active infection; diabetes mellitus; hypertension; symptomatic congestive heart failure, unstable angina pectoris, stroke or myocardial infarction within 3 months.
- The subject has a baseline corrected QT interval (QTc) > 460 ms.
- The subject is pregnant or breastfeeding.
- The subject is known to be positive for the human immunodeficiency virus (HIV).
- The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hospital of the University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
About this study
Official title: A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL888 in Subjects With Solid Tumors
The purpose of this study is to evaluate the safety and tolerability of XL888 in subjects with solid tumors. XL888 is a potent and selective inhibitor of HSP90, a key component of a molecular chaperone complex that promotes the conformational maturation and stabilization of diverse client proteins. Many HSP90 client proteins play critical roles in signaling pathways implicated in tumor cell growth, proliferation, and survival.
- Conditions
- Cancer
- Being tested
- XL888
- Keywords
- Cancer, Solid Tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XL888Drug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: XL888 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, tolerability, and maximum tolerated dose of oral administration of XL888 when administered on an intermittent schedule to adults with solid tumors
Measured: Assessed at several visits during weeks 1 through 4 of the first cycle and approximately every other week each cycle thereafter
Plasma pharmacokinetics of oral administration of XL888 when administered on an intermittent schedule
Measured: Assessed at several visits during weeks 1 through 4 of the first cycle and approximately once every four weeks each cycle thereafter
Secondary outcomes (3)
Pharmacodynamic effects of XL888 on both tumor tissue and non-tumor tissue
Measured: Assessed at specific visits during the first cycle; mandatory blood samples collected once every four weeks every cycle thereafter with optional tissue samples
Estimate renal elimination of XL888
Measured: Assessed during the first cycle after three weeks of dosing
Exploratory: To evaluate preliminary antitumor activity of XL888
Measured: Assessed every eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by ExelixisThe 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exelixis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796484
- Sponsor's protocol ID
- XL888-001
- Status last verified
- Aug 2015
- First submitted
- 20 Nov 2008
- Last updated
- 21 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL888 in Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT00796484
- Acronym / sponsor ID
- XL888-001
- Conditions
- Cancer
- Keywords
- Cancer, Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 33 participants (actual)
- Lead sponsor
- ExelixisIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 24 Nov 2008 (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.
The purpose of this study is to evaluate the safety and tolerability of XL888 in subjects with solid tumors. XL888 is a potent and selective inhibitor of HSP90, a key component of a molecular chaperone complex that promotes the conformational maturation and stabilization of diverse client proteins. Many HSP90 client proteins play critical roles in signaling pathways implicated in tumor cell growth, proliferation, and survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: XL888 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject has a histologically-confirmed tumor that is metastatic or unresectable and is no longer responding to therapies known to prolong survival or to other standard therapies, or has disease for which no effective therapy exists.
- For subjects enrolling in the maximum tolerated dose expansion cohorts:
- The subject is ≥ 18 years old.
- The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- The subject's weight is ≥ 40 kg.
Key exclusion criteria (13 listed)
- The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic therapy (cytokines, antibodies) within 3 weeks (or nitrosoureas or mitomycin C within 6 weeks) before the first dose of XL888.
- The subject has received prior treatment with a small molecule kinase inhibitor (including an investigational kinase inhibitor) or hormonal therapy within 14 days before the first dose of XL888.
- The subject has received any other type of investigational agent within 28 days before the first dose of study treatment.
- The subject has a previously-identified allergy or hypersensitivity to components of the study treatment formulation.
- The subject has not recovered from clinically-meaningful toxicity due to prior therapy.
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 |
|---|---|---|
| XL888Administered orally | Drug | 1 |
Primary outcome
Safety, tolerability, and maximum tolerated dose of oral administration of XL888 when administered on an intermittent schedule to adults with solid tumors
Time frame: Assessed at several visits during weeks 1 through 4 of the first cycle and approximately every other week each cycle thereafter
Plasma pharmacokinetics of oral administration of XL888 when administered on an intermittent schedule
Time frame: Assessed at several visits during weeks 1 through 4 of the first cycle and approximately once every four weeks each cycle thereafter
3 secondary outcomes
Pharmacodynamic effects of XL888 on both tumor tissue and non-tumor tissue
Time frame: Assessed at specific visits during the first cycle; mandatory blood samples collected once every four weeks every cycle thereafter with optional tissue samples
Estimate renal elimination of XL888
Time frame: Assessed during the first cycle after three weeks of dosing
Exploratory: To evaluate preliminary antitumor activity of XL888
Time frame: Assessed every eight weeks
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2015.
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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.
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 XL888 in people with Cancer, run by Exelixis at 2 sites in United States.
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 13 inclusion and 13 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 21 Aug 2015. 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 United States. 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 (reason given: Sponsor decision). 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?
Safety, tolerability, and maximum tolerated dose of oral administration of XL888 when administered on an intermittent schedule to adults with solid tumors (time frame: Assessed at several visits during weeks 1 through 4 of the first cycle and approximately every other week each cycle thereafter). The study lists 2 primary outcomes in all. 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 21 Aug 2015.