Bevacizumab and BKM-120 in Patients With Metastatic Renal Cell Carcinoma
This study is currently recruiting participants.
Verified June 2013 by Dana-Farber Cancer Institute
Sponsor:
Toni Choueiri, MD
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Toni Choueiri, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01283048
First received: January 24, 2011
Last updated: June 5, 2013
Last verified: June 2013
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Purpose
BKM-120 is a drug that may slow the growth of cancer cells. This drug has been used in laboratory experiments and information from those research studies suggests that this drug may help to slow the growth of renal cancer cells. In this research study, the investigators are testing the safety to BKM-120 at different dose levels. The investigators will also be studying how well tolerated BKM-120 is, and how effective BKM-120 can be in the treatment of kidney cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Cell Carcinoma |
Drug: BKM-120 Bevacizumab |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Bevacizumab and Escalation Doses of BKM-120 in Patients With Metastatic Renal Cell Carcinoma Who Failed Prior Systemic Therapies |
Resource links provided by NLM:
Further study details as provided by Dana-Farber Cancer Institute:
Primary Outcome Measures:
- To determine the maximum tolerated dose and dose limiting toxicities of the combination of BKM-120 and bevacizumab in metastatic renal cell carcinoma [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To determine additional toxicity and safety information from the combination of BKM-120 and bevacizumab in an expanded cohort of patients at the MTD [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
- To determine the objective response proportion, progression-free survival, overall survival of the combination of BKM-120 and bevacizumab [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To determine whether the BKM-120 and bevacizumab combination at the MTD is associated with concomitant changes in angiokines and PI3K pathway members in plasma and tumor samples [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 32 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: BKM-120 with Bevacizumab |
Drug: BKM-120 Bevacizumab
BKM-120 60, 80, 100 mg PO QD Bevacizumab 10 mg/Kg every 2 weeks
Other Name: Avastin
|
Detailed Description:
Subjects will receive an intravenous infusion of Avastin on Day 1 and Day 15 of each month (cycle). Subjects will take a daily oral dose of BKM-120 at the dose level assigned.
Subjects will have a clinic visit weekly during Cycle 1 and then on Day 1 and Day 15 of each cycle for blood tests and physical exam.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Metastatic RCC with clear cell component or papillary RCC
- Life expectancy > 12 weeks
- Must have failed at least 1 prior anti-VEGF systemic therapy for metastatic RCC
Exclusion Criteria:
- Prior treatment with a P13K inhibitor or bevacizumab
- Untreated brain metastases
- Acute or chronic liver or pancreatic disease
- Major mood disorder
- Concurrent severe and/or uncontrolled medical condition
- Diabetes mellitus
- GI disease
- Currently taking therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulant
- Pregnant or breastfeeding
- HIV positive
- History of another malignancy within 3 years except cured basal cell carcinoma of the skin or excised in situ carcinoma of the cervix
- Uncontrolled hypertension
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283048
Contacts
| Contact: Toni K Choueiri, MD | 617-632-5456 | Toni_Choueiri@dfci.harvard.edu |
Locations
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Stephanie Morrissey, RN 617-632-2382 | |
| Contact: Meghara Kane, RN 617-632-5264 | |
| Principal Investigator: Toni K Choueiri, MD | |
| Beth Israel Deaconess Medical Center | Not yet recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Daniel Cho, MD 617-632-9250 | |
| Contact: Janine Morrissey (617) 632-9285 'jmorriss@bidmc.harvard.edu' | |
Sponsors and Collaborators
Toni Choueiri, MD
Beth Israel Deaconess Medical Center
Investigators
| Principal Investigator: | Toni K Choueiri, MD | Dana-Farber Cancer Institute |
More Information
No publications provided
| Responsible Party: | Toni Choueiri, MD, Assistant Professor of Medicine, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01283048 History of Changes |
| Other Study ID Numbers: | 10-405 |
| Study First Received: | January 24, 2011 |
| Last Updated: | June 5, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Dana-Farber Cancer Institute:
|
Kidney Cancer Avastin |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases |
Urologic Diseases Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013