Study of Intravenous RXDX-107 in Patients With Solid Tumors

April 24, 2019 updated by: Hoffmann-La Roche

A Phase 1/1b, Multicenter, Open-Label Study of Intravenous RXDX-107 in Adult Patients With Locally Advanced or Metastatic Solid Cancer

This is an open-label, Phase I/Ib, dose escalation study of intravenous RXDX-107 administered to subjects with advanced solid tumors. The study is designed to explore the safety, maximum tolerated dose (MTD), pharmacokinetics, pharmacodynamics, and preliminary clinical activity of RXDX-107 and to define a recommended Phase 2 dose (RP2D)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Sarasota, Florida, United States, 34232
        • Florida Cancer Specialists
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Medical Institute
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Confirmed relapsed or refractory locally advanced or metastatic solid cancer for whom no standard therapy is considered appropriate, or for whom standard therapy is considered intolerable.
  2. >18 years of age.
  3. ECOG performance status of 0 or 1.
  4. Life expectancy of at least 3 months.

  5. Received the last dose of previous treatment / therapy before Day 1 of cycle 1:

    • 28 days for cytotoxic chemotherapy, immunotherapy, whole brain radiotherapy, anticonvulsive therapy, stereotactic radiosurgery and major surgery
    • 42 days for nitrosureas, mitomycin C, and liposomal anthracycline
    • 14 days for non-cytotoxic cancer therapies and radiotherapy
  6. Recovered from all toxic effects (excluding alopecia) of any prior anti-cancer therapy to Grade ≤ 1 or to the baseline laboratory values.
  7. Adequate organ function and baseline laboratory values
  8. Women of childbearing potential must have a negative serum pregnancy

Phase 1b: Patient must have measurable disease

Exclusion Criteria:

  1. Receiving other experimental therapy
  2. Known symptomatic brain mets or leptomeningeal involvement
  3. Myocardial infarction in the previous 12 weeks. Active ischemia or any other uncontrolled cardiac condition such as angina pectoris, significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, or CHF.
  4. Another concurrent illness which would preclude study conduct and assessment, uncontrolled: medical condition, active infection, risk of bleeding, diabetes mellitus, or pulmonary disease, or alcoholic liver disease, or primary biliary cirrhosis.
  5. Malignancy within 3 years or active disease requiring treatment other than the target cancer. The exceptions are prostate cancer (Gleason grade < 6 with normalized PSA levels), treated in situ cervical, breast carcinoma, squamous or basal cell skin cancer.
  6. Any condition that may compromise the ability to give written informed consent or to comply with the study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: RXDX-107
Drug: RXDX-107
Subjects in this study will receive RXDX-107 intravenously at dose levels specified for their respective dose cohorts. Dosing will begin at 25 mg/m2 on Day 1 and Day 2 of a 28-day cycle and will escalate until the maximum tolerated dose (MTD) or (RP2D) is determined. An additional schedule of administration of RXDX-107 on Day 1 of a 28 day cycle may be assessed. Cycles will be repeated in four-week (28 day) intervals for up to 6 cycles or until progression of disease, unacceptable toxicity, or another discontinuation criterion is met.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Phase 1: Safety profile of RXDX-107 as characterized by Adverse Events, ECG and laboratory abnormalities
Time Frame: Approx. 1 year
AEs, ECG and Labs assessed according to NCI CTCAE V4.0
Approx. 1 year
Phase 1: Maximum observed plasma drug concentration (Cmax)
Time Frame: Approx. 1 year
Plasma concentrations obtained following the dose on Day 1 (and from the dose on Day 2 in patients receiving the Day 1 and Day 2 schedule)
Approx. 1 year
Phase 1: Time to Cmax, by inspection (tmax)
Time Frame: Approx. 1 year
Plasma concentrations obtained following the dose on Day 1 (and from the dose on Day 2 in patients receiving the Day 1 and Day 2 schedule)
Approx. 1 year
Phase 1: Area under the drug concentration by time curve (AUC)
Time Frame: Approx. 1 year
From time 0 to the time of the last detectable plasma concentration (AUC0-t)
Approx. 1 year
Phase 1: Apparent plasma terminal elimination rate constant (λz) and associated terminal half life (t½)
Time Frame: Approx. 1 year
Plasma concentrations obtained following the dose on Day 1 (and from the dose on Day 2 in patients receiving the Day 1 and Day 2 schedule)
Approx. 1 year
Phase 1: Plasma clearance (CL)
Time Frame: Approx. 1 year
Plasma concentrations obtained following the dose on Day 1 (and from the dose on Day 2 in patients receiving the Day 1 and Day 2 schedule)
Approx. 1 year
Phase 1: Volume of distribution (Vz)
Time Frame: Approx. 1 year
Plasma concentrations obtained following the dose on Day 1 (and from the dose on Day 2 in patients receiving the Day 1 and Day 2 schedule)
Approx. 1 year
Phase 1: Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)
Time Frame: Approx. 6 months
Approx. 6 months
Phase 1b: Confirm RP2D
Time Frame: Approx. 1 year
Number of participants with Treatment-related AEs, Labs changes from baseline, and QTc interval changes from baseline assessed according to NCI CTCAE V4.0, concomitant medication usage, including all supportive care provided, and preliminary anti-tumor activity per RECIST v1.1 as assessed by Investigator
Approx. 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Antitumor activity of RXDX-107 as measured by Objective Response Rate (ORR)
Time Frame: Approx. 1 year
Per RECIST v1.1 as assessed by Investigator
Approx. 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RXDX-107-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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