Trebananib And Temsirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery
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|ClinicalTrials.gov Identifier: NCT01548482|
Recruitment Status : Completed
First Posted : March 8, 2012
Last Update Posted : October 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Adult Solid Neoplasm Lung Carcinoid Tumor Recurrent Digestive System Neuroendocrine Tumor G1 Recurrent Renal Cell Carcinoma Recurrent Uterine Corpus Sarcoma Stage III Renal Cell Cancer Stage IIIB Uterine Sarcoma Stage IIIC Uterine Sarcoma Stage IV Renal Cell Cancer Stage IVA Uterine Sarcoma Stage IVB Uterine Sarcoma||Other: Laboratory Biomarker Analysis Other: Pharmacological Study Drug: Temsirolimus Biological: Trebananib||Phase 1|
I. To determine the recommended phase II dose (RP2D) and safety profile of AMG 386 (trebananib) in combination with temsirolimus in patients with advanced solid tumors.
I. To evaluate pharmacodynamic (PD) effects of both drugs when administered in combination, with the goal of identifying potential predictive and PD markers that need further exploration and validation in future trials.
II. To explore preliminary anti-tumor activity of both drugs when administered at the RP2D to patients with advanced endometrial cancer, renal cell carcinoma, or carcinoid tumor.
OUTLINE: This is a dose-escalation study of trebananib.
Patients receive trebananib intravenously (IV) over 60 minutes and temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of AMG 386 and Temsirolimus in Advanced Solid Tumors With an Expansion Cohort in Uterine Cancer, Renal Cell Carcinoma and Carcinoid Tumor|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
Experimental: Treatment (trebananib, temsirolimus)
Patients receive trebananib IV over 60 minutes and temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
- RP2D of trebananib and temsirolimus defined as the dose level at which =< 1/6 patients experienced dose-limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) CTCAE version 4.0 [ Time Frame: 28 days ]
- Safety profile of trebananib and temsirolimus as assessed by NCI CTCAE version 4.0 [ Time Frame: Up to 30 days ]Frequency and severity of adverse events will be tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest. Adverse events will be summarized using all adverse events experienced, although a subanalysis may be conducted including only those adverse events in which the treating physician deems possibly, probably or definitely attributable to one or both study treatments.
- Objective response to treatment assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 [ Time Frame: Up to 30 days ]Predictors of clinical outcomes will be investigated using logistic regression, Cox proportional hazards regression and/or generalized estimating equations as appropriate.
- PD effects of both drugs when administered in combination [ Time Frame: Course 1 days 1, 3, and 8 and course 2 day 1 ]Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548482
|Canada, British Columbia|
|BCCA-Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Juravinski Cancer Centre at Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8V 5C2|
|University Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Philippe Bedard||University Health Network-Princess Margaret Hospital|