NCT00086528CompletedPhase 1
A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL647 Administered Orally to Subjects With Solid Tumors
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Kadmon Corporation, LLC
- Enrollment
- 41
- Locations
- 2
- Primary Endpoint
- To evaluate the safety and tolerability of XL647 administered orally as a single dose and as repeat doses
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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,
- •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.
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
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
Secondary Outcomes
- To evaluate the plasma pharmacokinetics of XL647 administered orally as a single dose and as repeat dose(At various time points between pre-treatment and post last treatment)
- To estimate renal elimination of XL647 administered orally as a single dose in subjects with solid tumors(At various time points between pre-treatment and post last treatment)
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Withdrawn
Phase 1
Safety Study of XL647 and XL147 Administered in Combination Daily in Adults With Solid TumorsNon-small-cell Lung CancerBreast CancerCancerNCT00704392Exelixis
Completed
Phase 1
Study Evaluating the Safety and Tolerability of Weekly Dosing of Oral IXAZOMIB in Adult Patients With Relapsed and Refractory Multiple MyelomaMultiple MyelomaNCT00963820Millennium Pharmaceuticals, Inc.60
Completed
Phase 1
Phase 1 Weekly Dosing of SCH 727965 in Patients With Advanced Cancer (Study P04629AM6)Solid TumorsLymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic. B-CellMultiple MyelomaNCT00871663Merck Sharp & Dohme LLC123
Completed
Phase 1
A Study of LY3532226 in Participants With ObesityObesityNCT06557356Eli Lilly and Company132
Terminated
Phase 1
Safety Study of Pharmacokinetics of XL888 in Adults With Solid TumorsCancerNCT00796484Exelixis33