A Multiple Ascending Dose Study of R1507 in Patients With Advanced Solid Tumors.
A Dose-escalation Study of R1507 in Patients With Advanced Solid Tumors.
1 other identifier
interventional
98
1 country
3
Brief Summary
This study will determine the maximum tolerated dose and pharmacokinetic profile of R1507 in patients with metastatic or locally advanced malignant solid tumors, non-Hodgkin's lymphoma or Hodgkin's lymphoma. Groups of patients will be sequentially enrolled to receive ascending doses of R1507 either weekly or three-weekly by intravenous infusion. The starting dose of 1mg/kg iv for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is \<100 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2006
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 15, 2006
CompletedFirst Posted
Study publicly available on registry
November 16, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedNovember 2, 2016
November 1, 2016
5 years
November 15, 2006
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
AEs, laboratory parameters, Cmax, Tmax, AUC, clearance, Vdss elimination half life
Throughout study
Secondary Outcomes (1)
Tumor response
Event driven
Study Arms (1)
1
EXPERIMENTALInterventions
Administered iv, either weekly or 3 weekly, at escalating doses (with a starting dose of 1mg/kg) (7 cohorts).
Eligibility Criteria
You may qualify if:
- adult patients, \>=18 years of age;
- solid neoplasm, non-Hodgkin's lymphoma or Hodgkin's lymphoma;
- metastatic or locally advanced disease, not curable by any currently available treatment.
You may not qualify if:
- severe, uncontrolled systemic disease;
- patients who require treatment with glucocorticoids or immunosuppressive treatment within last 6 months;
- patients with diabetes mellitus.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Unknown Facility
Aurora, Colorado, 80045, United States
Unknown Facility
New Brunswick, New Jersey, 08901, United States
Unknown Facility
Houston, Texas, 77030, United States
Related Publications (1)
Xin Y, Xu F, Gao Y, Bhatt N, Chamberlain J, Sile S, Hammel S, Holt RJ, Ramanathan S. Pharmacokinetics and Exposure-Response Relationship of Teprotumumab, an Insulin-Like Growth Factor-1 Receptor-Blocking Antibody, in Thyroid Eye Disease. Clin Pharmacokinet. 2021 Aug;60(8):1029-1040. doi: 10.1007/s40262-021-01003-3. Epub 2021 Mar 26.
PMID: 33768488DERIVED
MeSH Terms
Conditions
Interventions
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2006
First Posted
November 16, 2006
Study Start
April 1, 2006
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
November 2, 2016
Record last verified: 2016-11