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A Study in Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01226485
Recruitment Status : Completed
First Posted : October 22, 2010
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: RXDX-109 Phase 1

Detailed Description:
Participants may include those who have previously received treatment with another hedgehog smoothened (Hh/Smo) inhibitor (excluding RXDX-109).

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose-Escalation Study of LY2940680 in Patients With Advanced Cancer
Study Start Date : September 2010
Primary Completion Date : January 2015
Study Completion Date : October 2017
Arms and Interventions

Arm Intervention/treatment
Experimental: RXDX-109 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

Drug: RXDX-109
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.
Other Name: LY2940680


Outcome Measures

Primary Outcome Measures :
  1. Recommended phase 2 dose [ Time Frame: Time of first dose to time of last dose ]

Secondary Outcome Measures :
  1. 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 ]
  2. Pharmacokinetics, maximum concentration (Cmax) [ Time Frame: Cycle 1: Days 1, 2, 15 and 16; Cycles 2-4: Day 1 and Day 15 ]
  3. Pharmacokinetics, time of maximal concentration (Tmax) [ Time Frame: Cycle 1: Days 1, 2, 15 and 16; Cycles 2-4: Day 1 and Day 15 ]
  4. Number of patients with tumor response [ Time Frame: Baseline to study completion (estimated 8 weeks or until study discontinuation) ]
  5. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01226485


Locations
United States, Arizona
For additional information regarding investigative sites for this trial, contact 1-858-255-5959 Mon - Fri 9 AM - 5 PM Pacific Time (PST), or speak with your personal physician.
Scottsdale, Arizona, United States, 85260
United States, California
For additional information regarding investigative sites for this trial, contact 1-858-255-5959 Mon - Fri 9 AM - 5 PM Pacific Time (PST), or speak with your personal physician.
Redwood City, California, United States, 94063
United States, Colorado
For additional information regarding investigative sites for this trial, contact 1-858-255-5959 Mon - Fri 9 AM - 5 PM Pacific Time (PST), or speak with your personal physician.
Aurora, Colorado, United States, 80045
United States, Florida
For additional information regarding investigative sites for this trial, contact 1-858-255-5959 Mon - Fri 9 AM - 5 PM Pacific Time (PST), or speak with your personal physician.
Fort Myers, Florida, United States, 33908
For additional information regarding investigative sites for this trial, contact 1-858-255-5959 Mon - Fri 9 AM - 5 PM Pacific Time (PST), or speak with your personal physician.
Tampa, Florida, United States, 33612
United States, Nevada
For additional information regarding investigative sites for this trial, contact 1-858-255-5959 Mon - Fri 9 AM - 5 PM Pacific Time (PST), or speak with your personal physician.
Las Vegas, Nevada, United States, 89169
United States, New York
For additional information regarding investigative sites for this trial, contact 1-858-255-5959 Mon - Fri 9 AM - 5 PM Pacific Time (PST), or speak with your personal physician.
New York, New York, United States, 10065
United States, Oklahoma
For additional information regarding investigative sites for this trial, contact 1-858-255-5959 Mon - Fri 9 AM - 5 PM Pacific Time (PST), or speak with your personal physician.
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
For additional information regarding investigative sites for this trial, contact 1-858-255-5959 Mon - Fri 9 AM - 5 PM Pacific Time (PST), or speak with your personal physician.
Nashville, Tennessee, United States, 37203
United States, Texas
For additional information regarding investigative sites for this trial, contact 1-858-255-5959 Mon - Fri 9 AM - 5 PM Pacific Time (PST), or speak with your personal physician.
Fort Worth, Texas, United States, 76177
For additional information regarding investigative sites for this trial, contact 1-858-255-5959 Mon - Fri 9 AM - 5 PM Pacific Time (PST), or speak with your personal physician.
Houston, Texas, United States, 77030
For additional information regarding investigative sites for this trial, contact 1-858-255-5959 Mon - Fri 9 AM - 5 PM Pacific Time (PST), or speak with your personal physician.
Tyler, Texas, United States, 75702
Sponsors and Collaborators
Ignyta, Inc.
Investigators
Study Director: Call 1-858-255-5959 Mon - Fri 9 AM - 5 PM Pacific Time (PST) Ignyta, Inc.
More Information

Responsible Party: Ignyta, Inc.
ClinicalTrials.gov Identifier: NCT01226485     History of Changes
Other Study ID Numbers: RXDX-109-01
I4J-MC-HHBB ( Other Identifier: Ignyta, Inc. )
13200 ( Other Identifier: Ignyta, Inc. )
First Posted: October 22, 2010    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017

Keywords provided by Ignyta, Inc.:
Cancer
Terminal
Solid Tumor
End Stage
Metastatic

Additional relevant MeSH terms:
Neoplasms