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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

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