Phase Ib Study of LDK378 and AUY922 in ALK-rearranged Non-small Cell Lung Cancer
This study is not yet open for participant recruitment.
Verified January 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01772797
First received: January 17, 2013
Last updated: January 22, 2013
Last verified: January 2013
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Purpose
The primary purpose of the study is to estimate the maximum tolerated dose of the combination of LDK378 and AUY922. This study will assess the safety, tolerability, pharmacokinetics and preliminary evidence of anti-tumor activity of the combination of LDK378 and AUY922 in ALK-rearranged non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Anaplastic Lymphoma Kinase (ALK) Non-small Cell Lung Cancer |
Drug: LDK378 Drug: AUY922 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase Ib, Open-label, Dose Escalation Study of LDK378 and AUY922 in Patients With ALK-rearranged Non-small Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Incidence rate of Dose Limiting Toxicities (DLT) [ Time Frame: up to day 28 after the patient's first dose ] [ Designated as safety issue: Yes ]cycle = within the first 28 days of patient's first dose
Secondary Outcome Measures:
- Number of patients with adverse events [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]Characterize the safety and tolerability of LDK378 and AUY922 in patients
- Changes in laboratory values [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]Characterize the safety and tolerability of LDK378 and AUY922 in patients
- Assessments of electrocardiograms [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]Characterize the safety and tolerability of LDK378 and AUY922 in patients
- Assessments of dose interruptions, reductions, and dose intensity [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]Characterize the safety and tolerability of LDK378 and AUY922 in patients
- Plasma PK parameter of LDK378 and AUY922: Tmax [ Time Frame: 30 months ] [ Designated as safety issue: No ]Characterize single and multiple dose PK of LDK378 and AUY922 in patients
- Overall response rate (ORR) [ Time Frame: 30 months ] [ Designated as safety issue: No ]Assess the anti-tumor activity of LDK378 and AUY922
- Duration of Response (DoR) [ Time Frame: 30 months ] [ Designated as safety issue: No ]Assess the anti-tumor activity of LDK378 and AUY922
- Time to Response (TTR) [ Time Frame: 30 months ] [ Designated as safety issue: No ]Assess the anti-tumor activity of LDK378 and AUY922
- Progression free survival (PFS) [ Time Frame: 30 months ] [ Designated as safety issue: No ]Assess the anti-tumor activity of LDK378 and AUY922 per RECIST 1.1
- Number of patients with serious adverse events [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]Characterize the safety and tolerability of LDK378 and AUY922 in patients
- Plasma PK parameter of LDK378 and AUY922: Cmax [ Time Frame: 30 months ] [ Designated as safety issue: No ]Characterize single and multiple dose PK of LDK378 and AUY922 in patients
- Plasma PK parameter of LDK378 and AUY922: AUClast [ Time Frame: 30 months ] [ Designated as safety issue: No ]Characterize single and multiple dose PK of LDK378 and AUY922 in patients
- Plasma PK parameter of LDK378 and AUY922: AUCtau [ Time Frame: 30 months ] [ Designated as safety issue: No ]Characterize single and multiple dose PK of LDK378 and AUY922 in patients
- Plasma PK parameter of LDK378 and AUY922: Cmin [ Time Frame: 30 months ] [ Designated as safety issue: No ]Characterize single and multiple dose PK of LDK378 and AUY922 in patients
- Plasma PK parameter of LDK378 and AUY922: Racc [ Time Frame: 30 months ] [ Designated as safety issue: No ]Characterize single and multiple dose PK of LDK378 and AUY922 in patients
| Estimated Enrollment: | 65 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: LDK378 and AUY922 |
Drug: LDK378
LDK378 is a capsule to be taken daily by mouth.
Drug: AUY922
AUY922 is an intravenous infusion that will be administered by the investigative site to the patient on a weekly basis.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- locally advanced or metastatic NSCLC
- tumor must carry an ALK rearrangement in 15% or more of tumor cells as measured by FISH
- disease that can be evaluated by RECIST v1.1 and measurable disease
Exclusion Criteria:
- central nervous system (CNS) metastases that are symptomatic or require increasing steroids or CNS-directed therapy
- clinically significant cardiac dysfunction
- inadequate end organ function as defined by specified laboratory values
- use of medications known to be strong inhibitors or inducters of CYP3A4/5 that cannot be discontinued at least 1 week prior to start of treatment
- use of medications that are mainly metabolized by CYP3A4/5 or CYP2C9 that canno be discontinued at least 1 week prior to start of treatment
- clinically significant, uncontrolled impaired gastrointestinal function or GI disease
- prior treatment with a HSP90 inhibitor
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01772797
Contacts
| Contact: Novartis Pharmaceuticals | 1-888-669-6682 | |
| Contact: Novartis Pharmaceuticals |
Locations
| United States, Colorado | |
| University of Colorado Dept. of Anschutz Cancer (3) | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Jessica Bata 720-848-0655 Jessica.bata@ucdenver.edu | |
| Principal Investigator: Ross Camidge | |
| United States, Massachusetts | |
| Massachusetts General Hospital Mass General | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact 617-724-1223 | |
| Principal Investigator: Alice Shaw | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center Fox Chase Cancer (2) | Recruiting |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| Contact: Michael Oldfield 215-214-4297 Michael.oldfield@fccc.edu | |
| Principal Investigator: Ranee Mehra | |
| United States, Utah | |
| University of Utah / Huntsman Cancer Institute Huntsman | Recruiting |
| Salt Lake City, Utah, United States, 84103 | |
| Contact: Jessica Moehle 801-585-0443 jessica.moehle@hci.utah.edu | |
| Principal Investigator: Sunil Sharma | |
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: | NCT01772797 History of Changes |
| Other Study ID Numbers: | CLDK378X2102, 2012-004632-29 |
| Study First Received: | January 17, 2013 |
| Last Updated: | January 22, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
anaplastic lymphoma kinase, ALK-rearranged lung cancer, non-small cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Lymphoma Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013