A Trial of AMG 386 and Temsirolimus in Advanced Solid Tumors
This is a phase 1 study to find out if investigational drug AMG 386, when given by vein at different doses, in combination with temsirolimus, is safe for patients with advanced cancers.This study will also look for the best possible dose for the combination.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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 Tumors|
- Recommended phase II dose (RP2D) and safety profile of AMG 386 in combination with temsirolimus in patients with advanced solid tumors. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]The recommended phase II dose is defined as <1 out of 6 at highest dose level below the maximally administered dose. The safety profile will include the number of participants who experience an adverse event, description of adverse events, grade of events, relationship to the drugs, and frequency of events.
- Levels of certain biomarkers at different timepoints after AMG386 and Temsirolimus are administered. [ Time Frame: 2 years ] [ Designated as safety issue: No ]Tie2 Expressing Monocytes (TEMs), and circulating angiogenic factors (CAFs) and cytokines, including PlGF, SDF-1alpha, sVCAM-1, angiogenin, endostatin, FGF, PDGF, thrombospondin, VEGF, sVEGFR-1,2, and 3, and sESM1.
- Preliminary anti-tumor activity of both drugs when administered at the recommended phase 2 dose to patients with advanced endometrial cancer, renal cell carcinoma, or carcinoid tumor. [ Time Frame: 2 years ] [ Designated as safety issue: No ]Response Evaluation Criteria in Solid Tumors(RECIST) guideline (version 1.1)
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
|Experimental: AMG 386 and Temsirolimus||
Drug: AMG 386
AMG 386, IV over 60 minutes before Temsirolimus, on Days 1, 8, 15, 22 of every 28 day cycles.Drug: Temsirolimus
Temsirolimus, IV over 30-60 minutes after AMG 386, on Days 1, 8, 15, 22 of every 28 day cycles.
Other Name: Torisel
AMG 386 is an intravenous (given by vein) drug that blocks a protein called angiopoietin. As cancers grow they need to develop their own new blood supply to survive and this development of new blood supply vessels is known as angiogenesis. AMG 386 works by slowing or stopping the growth of these new blood vessels which is expected to interfere with the tumor's ability to grow and spread to other parts of the body.
Temsirolimus is an intravenous (given by vein) drug that is commercially available and approved for treatment of some types of kidney cancer. Temsirolimus interferes with a protein in the cell that is part of one pathway that transmits signals to stimulate cell growth and survival. By inhibiting this protein, called mTOR, cancer cells may stop growing or die.
This study has two parts. The first part, called the dose escalation phase, will include patients with any type of solid tumor (a cancer with a tissue mass) to find out the highest dose of AMG386 and temsirolimus that can be given to patients without causing side effects that are too severe. After this dose is found, another group of patients that take part in the study will receive this dose in the second phase called the dose expansion phase. The dose expansion phase of the study will only include patients that have recurrent (the cancer has come back) or metastatic uterine, renal cell, and carcinoid tumors.
|Contact: Monika Wizemann, BSc. (Hons)||email@example.com|
|Contact: Meghan Perry, BSc. (Hons)||416-946-4501 ext firstname.lastname@example.org|
|Princess Margaret Hospital||Not yet recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Philippe Bedard, M.D.||Princess Margaret Hospital, Canada|