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CancerPhase 1NCT00086528

Safety and Pharmacokinetics of XL647 Administered Orally to Subjects With Solid Tumors

A Phase 1 study testing XL647 in people with Cancer, run by Kadmon Corporation, LLC at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study is as follows: To evaluate the safety and tolerability of XL647 administered orally as a single dose and as repeat doses in subjects with 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
41 participants
Where
2 sitesUnited States
Study dates
Jun 2004to Nov 2007
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 malignancy that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective,
  • The subject has disease that is assessable by tumor marker, physical, or radiologic means,
  • The subject is ≥18 years old,
  • There have been at least 4 weeks since prior chemotherapy or radiation therapy (6 weeks if the last treatment regimen included BCNU or mitomycin C),
  • The subject has an ECOG performance status ≤2 (Karnofsky >60%),
  • The subject has a life expectancy of ≥3 months,
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  • The subject has normal organ and marrow function (hemoglobin >10g/dL, leukocytes >3,000/mL, absolute neutrophil count >1,500/µL, platelets >100,000/µL, total bilirubin within normal institutional limits of normal,AST (SGOT)/ALT(SGPT) <2.5 times the upper limit of normal, and creatinine within normal limits,
  • The subject is capable of understanding and complying with the protocol and has signed the informed consent document,
  • Sexually active subjects (both male and female) must use an accepted method of contraception during the course of the study,
  • Female subjects of childbearing potential (pre-menopausal) must have a negative pregnancy test.

Who cannot join

  • The subject has had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or has not recovered from AEs due to agents administered more than 4 weeks earlier,
  • The subject has received another investigational agent within 30 days (or 5.5 half-lives) of the first dose of study drug,
  • The subject has known brain metastases,
  • The subject has a corrected QT interval (QTc) of >0.44 seconds,
  • The subject has a history of allergic reactions attributed to aspartame or to any other component in the formulation vehicle,
  • The subject has an uncontrolled intercurrent illness including,but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements,
  • The subject is pregnant or nursing,
  • The subject is known to be positive for the human immunodeficiency virus (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

Other trials in United States

About this study

Official title: A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL647 Administered Orally to Subjects With Solid Tumors

The primary objective of this study is as follows:

  • To evaluate the safety and tolerability of XL647 administered orally as a single dose and as repeat doses in subjects with solid tumors.
Read more

The secondary objectives of this study are as follows:

  • To evaluate the plasma pharmacokinetics of XL647 administered orally as a single dose and as repeat doses in subjects with solid tumors,
  • To estimate renal elimination of XL647 administered orally as a single dose in subjects with solid tumors.

The exploratory objective of this study is as follows:

  • To assess the pharmacodynamic effects of XL647 administration in plasma and peripheral blood cells.

In addition, subjects may be eligible to enter a Treatment Extension Period. The following information will be obtained from this part of the study:

  • Long-term safety and tolerability of XL647 after repeat administration,
  • Tumor response after repeat administration of XL647.
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

    Administered orally as a solution with mass-based dosing in early cohorts or as 50-mg tablets at a fixed dose at the MTD. A minimum of 3 subjects was planned for each dosing cohort with dose escalation dependent on subject tolerance of the prior dose. During the Treatment Period, subjects in each cohort were administered a single dose of XL647 on Day 1 followed by a 72-hour period of observation. If there were no XL647-related dose limiting toxicities, subjects received 5 daily doses of XL647 on Days 4-8. Twenty-one days after the initial dose, in the absence of unacceptable toxicity or disease progression, subjects could enter a Treatment Extension Period that consisted of repeated 2-week cycles of five oral doses of XL647 followed by a 9-day observation period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the safety and tolerability of XL647 administered orally as a single dose and as repeat doses

    Measured: First treatment until 30 days post last treatment

Secondary outcomes (2)

  1. To evaluate the plasma pharmacokinetics of XL647 administered orally as a single dose and as repeat dose

    Measured: At various time points between pre-treatment and post last treatment

  2. To estimate renal elimination of XL647 administered orally as a single dose in subjects with solid tumors

    Measured: At various time points between pre-treatment and post last treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2004 (estimated)
  2. Study startJun 2004
  3. Primary completionJul 2007
  4. Study completionNov 2007

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00086528
Sponsor's protocol ID
XL647-001
Status last verified
May 2022
First submitted
2 Jul 2004
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

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 10 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?

To evaluate the safety and tolerability of XL647 administered orally as a single dose and as repeat doses (time frame: First treatment 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 NCT00086528, 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.

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