Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01131234
Other study ID # NCI-2011-01428
Secondary ID NCI-2011-01428CD
Status Completed
Phase Phase 1
First received May 25, 2010
Last updated December 22, 2014
Start date May 2010
Est. completion date September 2014

Study information

Verified date November 2014
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This phase I clinical trial is studying the side effects and best dose of giving gamma-secretase inhibitor RO4929097 and cediranib maleate together in treating patients with advanced solid tumors. Gamma-secretase inhibitor RO4929097 and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate also may stop the growth of tumor cells by blocking blood flow to the tumor.


Description:

Read more »
Read more »

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

Read more »

Intervention

Drug:
Gamma-Secretase Inhibitor RO4929097
Given PO
Cediranib Maleate
Given PO
Other:
Pharmacological Study
Correlative studies
Laboratory Biomarker Analysis
Correlative studies

Locations

Country Name City State
Canada Juravinski Cancer Centre at Hamilton Health Sciences Hamilton Ontario
Canada University Health Network-Princess Margaret Hospital Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recommended phase II dose of gamma-secretase inhibitor RO4929097 defined as the dose level at which < 1/6 patients experience dose-limiting toxicity as graded by the National Cancer Institute (NCI) CTCAE version 4.0 Frequency and severity of adverse events will be tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest. 42 days Yes
Primary Incidence of adverse events as graded by the NCI CTCAE version 4.0 Frequency and severity of adverse events will be tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest. Up to 4 weeks post-treatment Yes
Secondary PK profiles for both drugs PK parameters will be calculated by non-compartmental methods. On days 1, 10, 22, and 38 of course 1, and then on day 1 of courses 2-6 No
Secondary PD effects of gamma-secretase inhibitor RO4929097 when administered alone and in combined with cediranib maleate 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. On days 1 and 22 of course 1 and on day 1 of course 2 No
Secondary Preliminary antitumor efficacy Summary statistics, such as the mean, median, counts and proportion, will be used to describe patients' clinical characteristics. Objective response to treatment will be assessed using the RECIST criteria 1.1. Up to 4 weeks post-treatment No
See also
  Status Clinical Trial Phase
Completed NCT01987726 - Comprehensive Gene Sequencing in Guiding Treatment Recommendations Patients With Metastatic or Recurrent Solid Tumors
Completed NCT01881230 - Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer) Phase 2/Phase 3
Terminated NCT01918306 - GDC-0941 and Cisplatin in Treating Patients With Androgen Receptor-Negative Triple Negative Metastatic Breast Cancer Phase 1/Phase 2
Terminated NCT01705340 - Akt Inhibitor MK2206, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With Locally Advanced or Metastatic HER2-Positive Breast , Gastric, or Gastroesophageal Cancer That Cannot Be Removed By Surgery Phase 1
Terminated NCT01222377 - Endoscopic Breast Surgery in Treating Patients With Breast Cancer N/A
Completed NCT00602043 - F-18 16 Alpha-Fluoroestradiol-Labeled Positron Emission Tomography in Predicting Response to First-Line Hormone Therapy in Patients With Stage IV Breast Cancer Phase 2
Completed NCT00096109 - Tanespimycin in Treating Women With Refractory Locally Advanced or Metastatic Breast Cancer Phase 2
Completed NCT00244881 - A Phase II Study of AZD2171 in Breast Cancer Stage IV (10006202) Phase 2
Completed NCT00425672 - ONTAK® in Treating Patients With Advanced Breast Cancer That Did Not Respond to Previous Treatment Phase 1/Phase 2
Completed NCT00100750 - Tipifarnib and Gemcitabine Hydrochloride in Treating Women With Metastatic Breast Cancer Phase 1/Phase 2
Completed NCT00096434 - Sorafenib in Treating Patients With Metastatic Breast Cancer Phase 2
Completed NCT00057941 - Anastrozole and ZD1839 Compared With Fulvestrant and ZD1839 in Postmenopausal Women w/ Metastatic Breast Cancer Phase 2
Terminated NCT02892734 - Ipilimumab and Nivolumab in Treating Patients With Recurrent Stage IV HER2 Negative Inflammatory Breast Cancer Phase 2
Recruiting NCT03213041 - Pembrolizumab and Carboplatin in Treating Patients With Circulating Tumor Cells Positive Metastatic Breast Cancer Phase 2
Completed NCT02015559 - Mucoadhesive Oral Wound Rinse in Preventing and Treating Stomatitis in Patients With ER- or PR-Positive Metastatic or Locally Recurrent Breast Cancer That Cannot be Removed by Surgery Receiving Everolimus Phase 2
Completed NCT02728596 - S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER) N/A
Completed NCT03364348 - 4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer Phase 1
Completed NCT02897375 - Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors Phase 1
Completed NCT01672684 - Phase I: At-Home Support for Rural Women Using Group Video Calling Phase 1
Terminated NCT01149356 - RO4929097 And Exemestane in Treating Pre- and Postmenopausal Patients With Advanced or Metastatic Breast Cancer Phase 1