Clinical Trials Logo

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.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine the tolerability, maximum tolerated dose (equivalent to the recommended phase II dose), and safety profile of RO4929097 (gamma-secretase inhibitor RO4929097) in combination with cediranib (cediranib maleate) in patients with advanced malignancies.

SECONDARY OBJECTIVES:

I. To obtain pharmacokinetic (PK) profiles for RO4929097 when administered alone and for RO492907 and cediranib in combination, in order to evaluate for interactive effects in PK (if any) between these two agents.

II. To evaluate pharmacodynamic (PD) effects of RO492907 when administered alone and in combination, with the goal of identifying potential predictive and PD markers that need further exploration and validation in future trials.

III. To assess for preliminary antitumor efficacy of this drug combination, especially in breast cancer, malignant melanoma, colorectal cancer, pancreatic cancer, kidney cancer, high grade glioma, non-small-cell lung cancer, and ovarian cancer.

OUTLINE: This is a dose-escalation study.

Patients receive gamma-secretase inhibitor RO4929097 orally (PO) once daily (QD) on days 1-3, 8-10, and 15-17 (days 1-3, 8-10, 15-17 22-24, 29-31, and 36-38 of course 1) and cediranib maleate PO QD on days 1-21 (days 22-42 course 1 only). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks. ;


Study Design

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


Related Conditions & MeSH terms

  • Adult Anaplastic Astrocytoma
  • Adult Anaplastic Ependymoma
  • Adult Anaplastic Oligodendroglioma
  • Adult Brain Stem Glioma
  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Adult Mixed Glioma
  • Adult Solid Neoplasm
  • Astrocytoma
  • Brain Neoplasms
  • Breast Neoplasms
  • Breast Neoplasms, Male
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Renal Cell
  • Ependymoma
  • Germinoma
  • Glioblastoma
  • Glioma
  • Gliosarcoma
  • Lung Neoplasms
  • Male Breast Carcinoma
  • Melanoma
  • Neoplasms
  • Neoplasms, Germ Cell and Embryonal
  • Oligodendroglioma
  • Ovarian Neoplasms
  • Pancreatic Neoplasms
  • Rectal Neoplasms
  • Recurrent Adult Brain Neoplasm
  • Recurrent Breast Carcinoma
  • Recurrent Colon Carcinoma
  • Recurrent Melanoma
  • Recurrent Non-Small Cell Lung Carcinoma
  • Recurrent Ovarian Carcinoma
  • Recurrent Ovarian Germ Cell Tumor
  • Recurrent Pancreatic Carcinoma
  • Recurrent Rectal Carcinoma
  • Recurrent Renal Cell Carcinoma
  • Stage III Pancreatic Cancer
  • Stage III Renal Cell Cancer
  • Stage IIIA Colon Cancer
  • Stage IIIA Non-Small Cell Lung Cancer
  • Stage IIIA Ovarian Cancer
  • Stage IIIA Ovarian Germ Cell Tumor
  • Stage IIIA Rectal Cancer
  • Stage IIIA Skin Melanoma
  • Stage IIIB Breast Cancer
  • Stage IIIB Colon Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IIIB Ovarian Cancer
  • Stage IIIB Ovarian Germ Cell Tumor
  • Stage IIIB Rectal Cancer
  • Stage IIIB Skin Melanoma
  • Stage IIIC Breast Cancer
  • Stage IIIC Colon Cancer
  • Stage IIIC Ovarian Cancer
  • Stage IIIC Ovarian Germ Cell Tumor
  • Stage IIIC Rectal Cancer
  • Stage IIIC Skin Melanoma
  • Stage IV Breast Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Stage IV Ovarian Cancer
  • Stage IV Ovarian Germ Cell Tumor
  • Stage IV Pancreatic Cancer
  • Stage IV Renal Cell Cancer
  • Stage IV Skin Melanoma
  • Stage IVA Colon Cancer
  • Stage IVA Rectal Cancer
  • Stage IVB Colon Cancer
  • Stage IVB Rectal Cancer

NCT number NCT01131234
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 1
Start date May 2010
Completion date September 2014

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 NCT00425672 - ONTAK® in Treating Patients With Advanced Breast Cancer That Did Not Respond to Previous Treatment Phase 1/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 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