CancerPhase 1NCT00460278
Study of XL418 in Adults With Solid Tumors
A Phase 1 study testing XL418 in people with Cancer and Solid Tumors, run by Exelixis at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of XL418 in subjects with solid tumors. XL418 is a new chemical entity that inhibits a spectrum of targets, including Akt and p70S6K, that mediate PI3 Kinase / PTEN signaling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Solid Tumors
- What is being tested?
- XL418
- How many people
- 63 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2007to not given
- 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
- The subject has a histologically confirmed solid tumor that is metastatic or unresectable, for which standard curative or palliative measures do not exist or are no longer effective, and there are no known therapies to prolong survival.
- The subject has disease that is assessable by tumor marker, physical, or radiologic means.
- The subject is ≥18 years old.
- The subject's weight is ≥55 kg and ≤120 kg.
- The subject has an ECOG (Eastern Cooperative Oncology Group) performance status ≤2.
- The subject has adequate organ and marrow function.
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- For subjects who are to be enrolled into the expanded MTD cohort:
- tumor tissue amenable to serial biopsy; and
- additional informed consent.
- The subject is capable of understanding the protocol and has signed the informed consent document.
- Sexually active subjects (male and female) must use medically acceptable methods of contraception during the course of the study.
- Female subjects of childbearing potential must have a negative serum pregnancy test at screening.
- The subject has a normal fasting blood glucose level at screening.
- If a subject has received more than three prior regimens of cytotoxic chemotherapy, more than two biological regimens, or more than 3000 cGy to areas containing substantial marrow, the principal investigator (PI) and the sponsor will discuss subject suitability prior to enrollment.
- The subject has had no other diagnosis of malignancy (unless non-melanoma skin cancer, in situ carcinoma of the cervix, or a malignancy diagnosed ≥5 years ago, with no evidence of disease for 5 years prior to screening for this study).
Who cannot join
- The subject has received anticancer treatment (eg, chemotherapy, radiotherapy, cytokines, or hormones) within 30 days (6 weeks for nitrosoureas or mitomycin C) before the first dose of study drug.
- The subject has received radiation to ≥25% of his or her bone marrow within 30 days of treatment with XL418.
- The subject has not recovered either to Grade ≤1 from adverse events (AEs) or to within 10% of baseline values due to investigational or other agents administered more than 30 days prior to study enrollment.
- The subject has received another investigational agent within 30 days of the first dose of study drug.
- The subject has known brain metastases.
- The subject is known to have diabetes.
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- The subject has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, hypertension, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- The subject has psychiatric illness/social situations that would limit compliance with study requirements.
- The subject is pregnant or breast feeding.
- The subject is known to be positive for the human immunodeficiency virus (HIV).
- The subject has a known allergy or hypersensitivity to any of the components of the XL418 formulation.
- The subject has a baseline QTc interval >450 ms.
- The subject is unwilling or unable 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
Wayne State University
Detroit, Michigan, 48201
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 XL418 Administered Orally Daily to Subjects With Solid Tumors
The purpose of this study is to evaluate the safety and tolerability of XL418 in subjects with solid tumors. XL418 is a new chemical entity that inhibits a spectrum of targets, including Akt and p70S6K, that mediate PI3 Kinase / PTEN signaling.
- Conditions
- Cancer, Solid Tumors
- Being tested
- XL418
- 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.
XL418Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, tolerability, and maximum tolerated dose of XL418 with daily oral administration
Secondary outcomes (1)
Plasma pharmacokinetics and pharmacodynamic effects of daily oral administration of XL418
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2007 (estimated)
- Study startApr 2007
Why it stopped: Enrollment suspended due to low drug exposure.
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
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exelixis
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460278
- Sponsor's protocol ID
- XL418-001
- Status last verified
- Jun 2008
- First submitted
- 11 Apr 2007
- Last updated
- 4 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2008. 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 XL418 Administered Orally Daily to Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT00460278
- Acronym / sponsor ID
- XL418-001
- Conditions
- Cancer, Solid Tumors
- Keywords
- Cancer, Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Enrollment suspended due to low drug exposure.
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- ExelixisIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- First posted
- 13 Apr 2007 (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 XL418 in subjects with solid tumors. XL418 is a new chemical entity that inhibits a spectrum of targets, including Akt and p70S6K, that mediate PI3 Kinase / PTEN signaling.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- The subject has a histologically confirmed solid tumor that is metastatic or unresectable, for which standard curative or palliative measures do not exist or are no longer effective, and there are no known therapies to prolong survival.
- The subject has disease that is assessable by tumor marker, physical, or radiologic means.
- The subject is ≥18 years old.
- The subject's weight is ≥55 kg and ≤120 kg.
- The subject has an ECOG (Eastern Cooperative Oncology Group) performance status ≤2.
Key exclusion criteria (13 listed)
- The subject has received anticancer treatment (eg, chemotherapy, radiotherapy, cytokines, or hormones) within 30 days (6 weeks for nitrosoureas or mitomycin C) before the first dose of study drug.
- The subject has received radiation to ≥25% of his or her bone marrow within 30 days of treatment with XL418.
- The subject has not recovered either to Grade ≤1 from adverse events (AEs) or to within 10% of baseline values due to investigational or other agents administered more than 30 days prior to study enrollment.
- The subject has received another investigational agent within 30 days of the first dose of study drug.
- The subject has known brain metastases.
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 |
|---|---|---|
| XL418 | Drug | – |
Primary outcome
Safety, tolerability, and maximum tolerated dose of XL418 with daily oral administration
1 secondary outcome
Plasma pharmacokinetics and pharmacodynamic effects of daily oral administration of XL418
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2008.
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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 XL418 in people with Cancer and Solid Tumors, 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 15 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: paused, as of the sponsor's last update on 4 Jun 2008. 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?
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 XL418 with daily oral administration. 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 4 Jun 2008.