Overview

This trial is active, not recruiting.

Condition advanced cancer
Treatment rxdx-109
Phase phase 1
Sponsor Ignyta, Inc.
Start date September 2010
End date January 2015
Trial size 86 participants
Trial identifier NCT01226485, 13200, I4J-MC-HHBB, RXDX-109-01

Summary

The purpose of this study is to find a recommended dose level and schedule of dosing RXDX-109 (formerly LY2940680) that can safely be taken by patients with advanced cancer. The study will also explore the changes in a cancer marker level in skin, hair follicles, buccal cells, and tumor cells. Finally, the study will help document any antitumor activity this drug may have.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Part A (dose escalation: advanced solid tumors) - Daily dosing with RXDX-109 Part B (dose escalation: advanced solid tumors) - Twice Daily dosing with RXDX-109 (if necessary based on pharmacokinetic, pharmacodynamic and safety data) Part C (dose expansion: advanced solid tumors) - Dose and frequency as determined by parts A and B of the study Part D (dose expansion: advanced basal cell carcinoma) - Dose and frequency as determined by parts A and B of the study
rxdx-109 LY2940680
50 - 1000 mg administered orally for at least two 28 day cycles. Patients who demonstrate clinical benefit may receive treatment until discontinuation criteria are met.

Primary Outcomes

Measure
Recommended phase 2 dose
time frame: Time of first dose to time of last dose

Secondary Outcomes

Measure
Pharmacokinetics, area under the concentration - time curve (AUC)
time frame: Cycle 1: Days 1, 2, 15 and 16; Cycles 2-4: Day 1 and Day 15
Pharmacokinetics, maximum concentration (Cmax)
time frame: Cycle 1: Days 1, 2, 15 and 16; Cycles 2-4: Day 1 and Day 15
Pharmacokinetics, time of maximal concentration (Tmax)
time frame: Cycle 1: Days 1, 2, 15 and 16; Cycles 2-4: Day 1 and Day 15
Number of patients with tumor response
time frame: Baseline to study completion (estimated 8 weeks or until study discontinuation)
Change from baseline to study completion in Basal Cell Carcinoma Questionnaire
time frame: Baseline, study completion (estimated 8 weeks or until study discontinuation)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic. The patient must be, in the judgment of the investigator, an appropriate candidate for experimental therapy. - Have the presence of measurable or nonmeasurable disease - Have adequate organ function, including: - Hematologic: Absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L, platelets greater than or equal to 100 x 109/L, and hemoglobin greater than or equal to 9 g/dL. Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin until 5 days after the erythrocyte transfusion. - Hepatic: Bilirubin less than or equal to 1.5 times upper limits of normal (ULN), ALT, and aspartate transferase (AST) less than or equal to 2.0 times ULN. If the liver has tumor involvement AST and ALT equaling less than or equal to 5 times ULN are acceptable. - Renal: Serum creatinine less than or equal to 1.5 times ULN. - Have a performance status of less than or equal to 1 on the Eastern Cooperative Oncology Group (ECOG) scale - Have discontinued previous treatments for cancer and recovered from the acute effects of therapy (for example, at least 42 days for mitomycin-C or nitrosoureas, 28 days for other chemotherapy and biologics. At the discretion of the investigator, hormone refractory prostate cancer patients who are stable on gonadotropin-releasing hormone (GnRH) agonist therapy and breast cancer patients who are stable on antiestrogen therapy (for example, an aromatase inhibitor) may continue treatment Exclusion Criteria: - Have received treatment within 21 days of the initial dose of study drug with an experimental agent for noncancer indications that has not received regulatory approval for any indication. - Have serious preexisting medical conditions - Have symptomatic central nervous system (CNS) malignancy (with the exception of medulloblastoma) or metastasis (screening not required). Patients with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids and/or anticonvulsants, and their disease is asymptomatic and radiographically stable for at least 60 days. - Have known current hematologic malignancies or acute or chronic leukemia - Have a known active fungal, bacterial, and/or known viral infection including human immunodeficiency (HIV) or viral (A, B, or C) hepatitis (screening is not required) - Have a second primary malignancy that in the judgment of the investigator and sponsor may affect the interpretation of results - Have QTc interval of >500 msec on screening electrocardiogram - Patients who have previously received treatment with LY2940680

Additional Information

Official title A Phase 1 Dose-Escalation Study of LY2940680 in Patients With Advanced Cancer
Description Participants may include those who have previously received treatment with another hedgehog smoothened (Hh/Smo) inhibitor (excluding RXDX-109).
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Ignyta, Inc..