CancerPhase 1NCT00336765
Study of XL647 Administered Orally Daily to Patients With Solid Tumors
A Phase 1 study testing XL647 in people with Cancer, run by Kadmon Corporation, LLC at 2 sites in United States.
Trial summary
The purpose of this study is to assess the safety and tolerability of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR, VEGFR2, ErbB2, and EphB4) XL647 when given orally daily to adults with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- XL647
- Type of treatment
- Pill or oral medicine
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2006to Sep 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 histologically confirmed malignancy that is metastatic or unresectable
- Subject has disease that is assessable by tumor marker, physical, or radiologic means
- Subject is at least 18 years old
- Subject has an ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
- Subject has a life expectancy ≥ 3 months
- Subject has normal organ and marrow function
Show all 9Show fewer
- Subject gives written informed consent
- Subject must use an accepted method of contraception during the study
- Female subjects of childbearing potential must have a negative pregnancy test
Who cannot join
- Subject has received anticancer treatment within 30 days of first dose of XL647
- Subject has received another investigational agent within 30 days of first dose of XL647
- Subject has known brain metastases
- Subject has corrected QT interval (QTc) of > 0.45 seconds
- Subject is currently receiving anticoagulation therapy with warfarin
- Subject has uncontrolled intercurrent illness
- Subject is pregnant or breastfeeding
- Subject has known HIV
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic
Rochester, Minnesota, 55905
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL647 Administered Orally Daily to Subjects With Solid Tumors
The purpose of this study is to assess the safety and tolerability of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR, VEGFR2, ErbB2, and EphB4) XL647 when given orally daily to adults with advanced solid tumors.
- Conditions
- Cancer
- Being tested
- XL647
- Keywords
- 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.
XL647Drug
Also called KD019
Tablets supplied in 50-mg strength administered orally daily
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate safety, tolerability, and maximum tolerated dose of XL647
Measured: Inclusion until 30 days post last treatment
Secondary outcomes (2)
Characterize pharmacokinetics and pharmacodynamic effects of XL647
Measured: At various time points from pre-dosing until post dosing
Evaluate preliminary tumor response
Measured: Inclusion until disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2006 (estimated)
- Study startJul 2006
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kadmon Corporation, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336765
- Sponsor's protocol ID
- XL647-002
- Status last verified
- May 2022
- First submitted
- 12 Jun 2006
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Das M, Padda SK, Frymoyer A, Molina J, Adjei A, Lensing JL, Miles D, Sikic BI, Wakelee HA. A safety, tolerability, and pharmacokinetic analysis of two phase I studies of multitargeted small molecule tyrosine kinase inhibitor XL647 with an intermittent and continuous dosing schedule in patients with advanced solid malignancies. Cancer Chemother Pharmacol. 2018 Sep;82(3):541-550. doi: 10.1007/s00280-018-3646-0. Epub 2018 Jul 20.
PubMed 30030583
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. 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 XL647 Administered Orally Daily to Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT00336765
- Acronym / sponsor ID
- XL647-002
- Conditions
- Cancer
- Keywords
- solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Kadmon Corporation, LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 14 Jun 2006 (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 assess the safety and tolerability of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR, VEGFR2, ErbB2, and EphB4) XL647 when given orally daily to adults with advanced solid tumors.
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 (9 listed)
- Subject has histologically confirmed malignancy that is metastatic or unresectable
- Subject has disease that is assessable by tumor marker, physical, or radiologic means
- Subject is at least 18 years old
- Subject has an ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
- Subject has a life expectancy ≥ 3 months
Key exclusion criteria (8 listed)
- Subject has received anticancer treatment within 30 days of first dose of XL647
- Subject has received another investigational agent within 30 days of first dose of XL647
- Subject has known brain metastases
- Subject has corrected QT interval (QTc) of > 0.45 seconds
- Subject is currently receiving anticoagulation therapy with warfarin
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 |
|---|---|---|
| XL647Also: KD019Tablets supplied in 50-mg strength administered orally daily | Drug | – |
Primary outcome
Evaluate safety, tolerability, and maximum tolerated dose of XL647
Time frame: Inclusion until 30 days post last treatment
2 secondary outcomes
Characterize pharmacokinetics and pharmacodynamic effects of XL647
Time frame: At various time points from pre-dosing until post dosing
Evaluate preliminary tumor response
Time frame: Inclusion until disease progression
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 13 May 2022.
- Background: PubMed 30030583Das M, Padda SK, Frymoyer A, Molina J, Adjei A, Lensing JL, Miles D, Sikic BI, Wakelee HA. A safety, tolerability, and pharmacokinetic analysis of two phase I studies of multitargeted small molecule tyrosine kinase inhibitor XL647 with an intermittent and continuous dosing schedule in patients with advanced solid malignancies. Cancer Chemother Pharmacol. 2018 Sep;82(3):541-550. doi: 10.1007/s00280-018-3646-0. Epub 2018 Jul 20.
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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 XL647 in people with Cancer, run by Kadmon Corporation, LLC 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 9 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: finished, as of the sponsor's last update on 13 May 2022. 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 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?
Evaluate safety, tolerability, and maximum tolerated dose of XL647 (time frame: Inclusion until 30 days post last treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00336765, which also lists 1 linked publication.
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 13 May 2022.