NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922)
NCT03107988
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
323-361-5687
- Patients must have a diagnosis of neuroblastoma either by histologic verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines
- Patients are required to have an activating ALK aberration in their tumor detected by certified assay (i.e. CLIA in the US.) prior to registration. The report from this test is required to be submitted for eligibility. Patients with at least one of the following genetic features in their tumor will be considered to have an activating ALK aberration:
1. An ALK activating mutation;
2. ALK amplification (> 10 signals of the ALK gene);
3. Presence of any ALK fusion protein that arises from a chromosomal translocation.
- Patients must have high risk neuroblastoma according to COG risk classification at the time of study registration. Patients who were initially considered low or intermediate risk, but then reclassified as high risk are also eligible.
- Patients must have at least ONE of the following: 1) Recurrent/progressive disease at any time prior to study enrollment, 2) Refractory disease, 3) Persistent disease
- Patients must have at least ONE of the following: 1) Bone disease, 2) Any amount of neuroblastoma tumor cells in the bone marrow, 3) At least one soft tissue lesion that meets criteria for a TARGET lesion, 4) At least one non-target soft tissue lesion that is not measurable, but had a biopsy positive for neuroblastoma and/or ganglioneuroblastoma at any time prior to enrollment or is MIBG avid
- Patients must have a Lansky (≤16 years) or Karnofsky (> 16 years) score of at least 50
- Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
- Patients must not have been previously treated with lorlatinib.
- Patients must not have received any of the specified therapies as stated in the protocol in the time period prior to registration
- Patients must not be receiving any other anti-cancer agents or radiotherapy at the time of study entry or while on study.
- Patients must not be receiving other investigational medications (covered under another IND) within 30 days of study entry or while on study.
- Patients must not be receiving chronic systemic corticosteroids at doses greater than physiologic dosing (inhaled corticosteroids acceptable).
- Patient must meet the organ function and system function requirements as stated in the protocol
- Pregnancy, breast feeding, or unwillingness to use effective contraception during the
study.
- Patients who, in the opinion of the investigator, may not be able to comply with the
safety monitoring requirements of the study.
- Patients with disease of any major organ system that would compromise their ability to
withstand therapy.
- Patients who have received prior allogeneic stem cell transplant
- Patients who are on hemodialysis.
- Patients with an active or uncontrolled infection.
- Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or
hepatitis C.
- Patient declines participation in NANT 2004-05, the NANT Biology Study
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Los Angeles, California
- San Francisco, California
- Aurora, Colorado
- Atlanta, Georgia
- Chicago, Illinois
- Boston, Massachusetts
- Ann Arbor, Michigan
- Chapel Hill, North Carolina
- Cincinnati, Ohio
- Philadelphia, Pennsylvania
- Fort Worth, Texas
- Seattle, Washington
- Sutton, Surrey
- Toronto, Ontario
- Paris, Cedex
Descriptive Information | |||||
---|---|---|---|---|---|
Brief Title ICMJE | NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922) | ||||
Official Title ICMJE | Phase 1 Study of Lorlatinib (PF-06463922), an Oral Small Molecule Inhibitor of ALK/ROS1, for Patients With ALK-Driven Relapsed or Refractory Neuroblastoma | ||||
Brief Summary | Lorlatinib is a novel inhibitor across ALK variants, including those resistant to crizotinib. In this first pediatric phase 1 trial of lorlatinib, the drug will be utilized as a single agent and in combination with chemotherapy in patients with relapsed/refractory neuroblastoma. The dose escalation phase of this study (Cohort A1) uses a traditional Phase I 3+3 design. Once a recommended phase 2 pediatric dose is identified, an expansion cohort of 6 patients (Cohort B1), within which ALKi naïve patients will be prioritized, will be initiated. Parallel cohorts will be initiated in adults or patients with large BSA (Cohort A2) and in combination with chemotherapy upon establishing RP2D (Cohort B2). | ||||
Detailed Description | Lorlatinib is a novel inhibitor across ALK variants, including those resistant to crizotinib. An adult phase 1 study established an RP2D of 100mg QD for lorlatinib. In this first pediatric phase 1 trial of lorlatinib, the drug will be utilized as a single agent and in combination with chemotherapy in patients with relapsed/refractory neuroblastoma. The dose escalation phase of this study (Cohort A1) uses a traditional Phase I 3+3 design. Once a recommended phase 2 pediatric dose is identified, an expansion cohort of 6 patients (Cohort B1), within which ALKi naïve patients will be prioritized, will be initiated. Parallel cohorts will be initiated in adults or patients with large BSA (Cohort A2) and in combination with chemotherapy upon establishing RP2D (Cohort B2). Lorlatinib will be administered orally via tablets or via oral dispersion if patient is unable to swallow tablets whole All patients will participate in mandatory pharmacokinetic testing. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||
Condition ICMJE | Neuroblastoma | ||||
Intervention ICMJE |
| ||||
Study Arms ICMJE |
| ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 40 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 2020 | ||||
Estimated Primary Completion Date | May 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
Sex/Gender ICMJE |
| ||||
Ages ICMJE | 1 Year to 90 Years (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
| ||||
Listed Location Countries ICMJE | Canada, France, United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03107988 | ||||
Other Study ID Numbers ICMJE | NANT2015-02 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
| ||||
IPD Sharing Statement ICMJE |
| ||||
Responsible Party | New Approaches to Neuroblastoma Therapy Consortium | ||||
Study Sponsor ICMJE | New Approaches to Neuroblastoma Therapy Consortium | ||||
Collaborators ICMJE |
| ||||
Investigators ICMJE |
| ||||
PRS Account | New Approaches to Neuroblastoma Therapy Consortium | ||||
Verification Date | December 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |