Status:
COMPLETED
Study of RXDX-105, Potent RET Inhibitor in Patients With Advanced Lung Cancer and Other Solid Tumors
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a first-in-human, multicenter, open-label study consisting of 2 phases. Phase 1 is a dose escalation study of RXDX-105 (formerly known as CEP-32496) in patients with advanced solid tumors aime...
Detailed Description
The primary objective of Phase 1 is to determine the recommended Phase 2 dose (RP2D) of RXDX-105. The primary objective of Phase 1b is to further assess the safety profile and tolerability of RXDX-105...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Phase 1b:
- Patients must have histologically or cytologically confirmed advanced solid tumors with a histology and/or molecular alteration of interest as defined in Section 4, detected by a CLIA-certified or equivalently accredited diagnostic laboratory
- • Squamous NSCLC and Non-squamous NSCLC (no known RET alterations or BRAF V600E mutations) patients must have archival tissue available for analysis by Ignyta; all other patients must send tissue to Ignyta, if tissue is available
- Prior Treatment:
- Patients with BRAF V600E mutations must be TKI-naïve; any number of other prior therapies are allowed
- NSCLC patients with RET alterations who have had a prior RET inhibitor or are RET inhibitor-naïve will be enrolled; (any number of other prior therapies are allowed); all other histologies with RET alterations must be RET inhibitor-naïve
- Patients with Squamous NSCLC and Non-squamous NSCLC (no known RET alterations or BRAF V600E mutations) may have had prior TKIs and any number of other prior therapies
- Measurable disease according to RECIST v1.1 for all patients except patients with RET altered tumors; patients with RET altered tumors must have evaluable disease, but are not required to have measurable disease
- Patients with treated, stable CNS metastases, including leptomeningeal carcinomatosis are allowed. The use of seizure prophylaxis is allowed. Patients requiring steroids must be at a stable or decreasing dose for at least 2 weeks prior to the start of RXDX-105 treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Able to ingest oral medication
- Other inclusion criteria apply
- Exclusion Criteria for Phase 1b:
- Treated with systemic anticancer therapy or an investigational agent within 2 weeks or 5 half-lives, whichever is shorter, prior to start of study drug treatment (4 weeks for antibody therapy and immunotherapy, and 2 weeks for bevacizumab in colon cancer patients)
- Major surgery 21 days or less prior to starting study drug or has not recovered from adverse effects of such therapy
- Radiotherapy within 2 weeks prior to start of study drug treatment (palliative radiation or stereotactic radiosurgery within 7 days prior to start of study treatment). Patients must have recovered from all radiotherapy-related toxicities
- History of non-pharmacologically induced prolonged QTc interval (e.g., repeated demonstration of a QTc interval \> 500 milliseconds from ECGs performed at least 24 hours apart)
- Major active infection requiring parenteral antibiotics
- Severe or unstable medical condition, such as congestive heart failure (New York Heart Association \[NYHA\] Class III or IV), ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, psychiatric condition, as well as an uncontrolled cardiac arrhythmia requiring medication (≥ Grade 2, according to NCI CTCAE v4.03), myocardial infarction within 6 months prior to starting study treatment, or any other significant or unstable concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy
- History of other previous cancer that would interfere with the determination of safety or efficacy of RXDX-105 with respect to the qualifying solid tumor malignancy
- Known infection with human immunodeficiency virus (HIV) and active hepatitis B or hepatitis C
- Current participation in another clinical study of an investigational agent, vaccine, or device. Concomitant participation in observational studies is acceptable
- Presence of a significant gastrointestinal disorder that, in the opinion of the Investigator or Sponsor, could interfere with absorption of RXDX-105 (e.g., malabsorption syndrome, gastrointestinal surgery)
- Known hypersensitivity to any of the components of RXDX-105
Exclusion
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2019
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT01877811
Start Date
June 1 2013
End Date
February 1 2019
Last Update
April 25 2019
Active Locations (14)
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1
City of Hope
Duarte, California, United States
2
University of California Irvine College of Medicine
Irvine, California, United States
3
University of California San Diego Moores Cancer Center
San Diego, California, United States
4
Lombardi Comprehensive Cancer Center, Georgetown
Washington D.C., District of Columbia, United States