Primary objective:To assess the safety, tolerability and pharmacokinetics of a single IV dosages of OTL-038. Selected doses of OTL-038 will be studied in the absence and presence of prophylactic treatment with the antihistamine clemastine to be…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) Safety is the primary endpoint of the study and it will be assessed from
data on the occurrence of 1 or more treatment-emergent adverse events (TEAEs)
from the time of administration throughout the study period, and changes in
serum biochemistry, hematology, urinalysis, vital signs, ECG, injection site
status, and physical examination findings.
Secondary outcome
2) Analysis of the PK of OTL-038.
Background summary
Surgery is the main stay in the (initial) treatment of many solid tumors.
Complete resection and if at all possible removal of local metastases have been
shown to be an important prognostic indicator for survival. This is however
difficult to achieve when the surgical field is observed with the naked eye
only. Therefore, agents that aid to increase the likelihood of complete
resection are being developed. These agents are directed towards tumor-specific
targets and emit light at non-visible wavelengths upon binding with the target.
This enables by using cameras that capture the emitted light to identify
malignant tissues and distinguish it from normal tissues. OTL-038 is an imaging
agent that specifically binds to the folate receptor A (FR-a) which is
expressed by various tumors such as ovarian, lung, breast and renal carcinomas.
OTL-038 emits lights with wave lengths in the near-infrared (NIR) spectrum and
preclinical data have shown that with appropriate camera systems this light can
be detected from tumor tissues.
As there is no clinical experience with OTL-038 this will be the first in human
study in which OTL-038 will be investigated in healthy volunteers. In this
study, four single ascending iv doses of OTL-038 or placebo will be
administered to healthy volunteers.
Study objective
Primary objective:
To assess the safety, tolerability and pharmacokinetics of a single IV dosages
of OTL-038. Selected doses of OTL-038 will be studied in the absence and
presence of prophylactic treatment with the antihistamine clemastine to be
administered at 10 min before OTL-038 dosing.
Exploratory objective:
To assess the pharmacodynamics of OTL-038 by measuring the temporal
relationship of fluorescence of superficial tissues (skin, veins) and an
external reference containing OTL-038.
Study design
Single ascending dose, randomized, placebo-controlled design in healthy
volunteers.
Study burden and risks
The risks of participation for the subjects in the trial include temporary
discoloration of skin and urine and hypersensitivity reactions. These risks are
deemed minimal. Nevertheless precautionary measures (supervised administration
by qualified staff and availability of medical treatment to treat
hypersensitivity reactions) are in place and these effects are generally well
manageable. The burden of the trial is minimal, consisting of 1 dag & night in
house stay with limited invasive measures. There are no expected direct
benefits to subjects who participate in this trial, but participants may help
others prospectively by contributing to the knowledge base for designing future
studies to evaluate the use of OTL-038 injection in patients with high
suspicion of a FR-a positive cancer.
Commercial Ave 4065
Northbrook IL 60062-1851
US
Commercial Ave 4065
Northbrook IL 60062-1851
US
Listed location countries
Age
Inclusion criteria
*The subject is 18-65 years old at screening.
*The subject is able and willing to comply with study procedures, and signed and dated informed consent is obtained before any study-related procedure is performed.
*Female subjects need to be either surgically sterile, post menopausal or pre-menopausal with a negative urine pregnancy test at screening and just before administration of OTL-038. Pre-menopausal female subjects should also employ an effective method of birth control for at least one month when it consists of a hormonal contraceptive method or IUD. For non-hormonal contraceptive methods females have to agree to use a double-barrier method.
*The subject*s body mass index is <=30 kg/m2.
*The subject has a normal or clinically acceptable medical history, physical examination, and vital signs findings at screening (within 21 days before administration of study drug).
*The subject*s screening ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits they are considered to be clinically insignificant.
*The subject has negative screening test results for hepatitis B, hepatitis C, and human immunodeficiency virus.
*The subject has negative test results for drug and alcohol screening.
*The subject has Fitzpatrick skin type I-II-III-IV
Exclusion criteria
The female subject is lactating or pregnant.
The subject has been previously included in this study.
The subjects uses prescription drugs
The subjects uses OTC-drugs that may have an impact on the study objectives.
Treatment with another investigational drug within 3 months prior to screening or more than 4 times a year.
*History of anaphylactic reactions.
*History of allergy to any of the components of OTL-038 or clemastine
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-004774-10-NL |
| CCMO | NL47020.056.13 |