Safety of BKM120 Monotherapy in Advanced Solid Tumor Patients
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01068483
First received: February 11, 2010
Last updated: April 9, 2013
Last verified: April 2013
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Purpose
This is a first-in-man, phase I clinical research study with BKM120, a potent and highly specific oral pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor. The study consists of a dose escalation part followed by a MTD expansion part.
Once the MTD has been defined, the MTD expansion part will be opened for enrollment.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Colon Cancer Ovarian Cancer Endometrium Cancer |
Drug: BKM120 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase IA, Multicenter, Open-label Dose Escalation Study of BKM120, Administered Orally in Adult Patients With Advanced Solid Malignancies |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Maximum Tolerated Dose (MTD) of BKM120 [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Safety and tolerability of BKM120 [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
- Pharmacokinetics of BKM120 [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
- Changes in tumor metabolic activity [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
- Pharmacodynamics of BKM120 [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
- Clinical tumor response in patients with tumors that show PI3K pathway activation [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
| Enrollment: | 107 |
| Study Start Date: | November 2008 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BKM120
Dose escalation followed by dose expansion
|
Drug: BKM120 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
All patients:
- Histologically-confirmed advanced solid tumors
- Progressive, recurrent unresectable disease
- World Health Organization (WHO) Performance status ≤ 2
- No history of primary brain tumor or brain metastases
MTD Expansion part:
- Histologically-confirmed advanced solid tumors
- Progressive, recurrent unresectable disease
- World Health Organization (WHO) Performance status ≤ 2
- No history of primary brain tumor; no brain metastases unless asymptomatic and clinically stable for ≥ 3 months
- Patients with genetic or molecular alteration of the PI3K pathway
Exclusion Criteria:
- Prior treatment with a PI3K inhibitor
- History of or active major depressive episode, bipolar disorder, schizophrenia, or history of suicidal attempt or ideation
- No clinically manifest diabetes mellitus (treated and/or with clinical signs)
- No acute or chronic renal disease
- No acute or chronic liver disease
- No acute or chronic pancreatitis
- No unresolved diarrhea
- No impaired cardiac function or clinically significant cardiac diseases such as ventricular arrhythmia, congestive heart failure, uncontrolled hypertension
- No acute myocardial infarction or unstable angina pectoris within the past 3 months
- Not pregnant or nursing and fertile patients must use barrier contraceptives
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01068483
Locations
| United States, Tennessee | |
| Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(4) | |
| Nashville, Tennessee, United States, 37203 | |
| Canada, Ontario | |
| Novartis Investigative Site | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Netherlands | |
| Novartis Investigative Site | |
| Rotterdam, Netherlands, 3015 CE | |
| Novartis Investigative Site | |
| Rotterdam, Netherlands, 3075 EA | |
| Spain | |
| Novartis Investigative Site | |
| Barcelona, Cataluna, Spain, 08035 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01068483 History of Changes |
| Other Study ID Numbers: | CBKM120X2101, 2008-002652-17 |
| Study First Received: | February 11, 2010 |
| Last Updated: | April 9, 2013 |
| Health Authority: | United States: Food and Drug Administration Spain: Ministry of Agriculture, Fisheries and Food The Netherlands: Department of Public Healthand Environmental Protection Canada: Health Canada |
Keywords provided by Novartis:
|
Advanced solid tumors Breast Cancer Colon Cancer Ovarian Cancer Endometrium cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Colonic Neoplasms Ovarian Neoplasms Endometrial Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Uterine Neoplasms Uterine Diseases |
ClinicalTrials.gov processed this record on June 17, 2013