Solid TumorPhase 1NCT02548390
Study of Intravenous RXDX-107 in Patients With Solid Tumors
A Phase 1 study testing RXDX-107 in people with Solid Tumor, run by Hoffmann-La Roche at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- RXDX-107
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2015to Sep 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- >18 years of age.
- ECOG performance status of 0 or 1.
- Life expectancy of at least 3 months.
- 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
Show all 12Show fewer
- 42 days for nitrosureas, mitomycin C, and liposomal anthracycline
- 14 days for non-cytotoxic cancer therapies and radiotherapy
- Recovered from all toxic effects (excluding alopecia) of any prior anti-cancer therapy to Grade ≤ 1 or to the baseline laboratory values.
- Adequate organ function and baseline laboratory values
- Women of childbearing potential must have a negative serum pregnancy
- Phase 1b: Patient must have measurable disease
Who cannot join
- Receiving other experimental therapy
- Known symptomatic brain mets or leptomeningeal involvement
- 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.
- 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.
- 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.
- Any condition that may compromise the ability to give written informed consent or to comply with the study protocol.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins Medical Institute
Baltimore, Maryland, 21205
Tennessee Oncology, LLC
Nashville, Tennessee, 37203
Florida Cancer Specialists
Sarasota, Florida, 34232
About this study
Official title: 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)
- Conditions
- Solid Tumor
- Being tested
- RXDX-107
- Keywords
- Phase 1/1b, open-label, dose-escalation, pharmacokinetics, solid tumor, metastatic cancer, chemotherapy, nano formulation, alkylator
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RXDX-107Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| RXDX-107 | Experimental | Not described Receives: Drug: RXDX-107 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Safety profile of RXDX-107 as characterized by Adverse Events, ECG and laboratory abnormalities
AEs, ECG and Labs assessed according to NCI CTCAE V4.0
Measured: Approx. 1 year
Phase 1: Maximum observed plasma drug concentration (Cmax)
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)
Measured: Approx. 1 year
Phase 1: Time to Cmax, by inspection (tmax)
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)
Measured: Approx. 1 year
Phase 1: Area under the drug concentration by time curve (AUC)
From time 0 to the time of the last detectable plasma concentration (AUC0-t)
Measured: Approx. 1 year
Phase 1: Apparent plasma terminal elimination rate constant (λz) and associated terminal half life (t½)
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)
Measured: Approx. 1 year
Phase 1: Plasma clearance (CL)
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)
Measured: Approx. 1 year
Phase 1: Volume of distribution (Vz)
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)
Measured: Approx. 1 year
Phase 1: Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)
Measured: Approx. 6 months
Phase 1b: Confirm RP2D
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
Measured: Approx. 1 year
Secondary outcomes (1)
Antitumor activity of RXDX-107 as measured by Objective Response Rate (ORR)
Per RECIST v1.1 as assessed by Investigator
Measured: Approx. 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548390
- Sponsor's protocol ID
- RXDX-107-01
- Status last verified
- Apr 2019
- First submitted
- 9 Sep 2015
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1b, Multicenter, Open-Label Study of Intravenous RXDX-107 in Adult Patients With Locally Advanced or Metastatic Solid Cancer
- ClinicalTrials.gov ID
- NCT02548390
- Acronym / sponsor ID
- RXDX-107-01
- Conditions
- Solid Tumor
- Keywords
- Phase 1/1b, open-label, dose-escalation, pharmacokinetics, solid tumor, metastatic cancer, chemotherapy, nano formulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 14 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RXDX-107 | Experimental | Drug: RXDX-107 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
- >18 years of age.
- ECOG performance status of 0 or 1.
- Life expectancy of at least 3 months.
- Received the last dose of previous treatment / therapy before Day 1 of cycle 1:
Key exclusion criteria (6 listed)
- Receiving other experimental therapy
- Known symptomatic brain mets or leptomeningeal involvement
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RXDX-107Subjects 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. | Drug | RXDX-107 |
Primary outcome
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
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)
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)
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)
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)
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)
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)
Phase 1: Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)
Time frame: 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
1 secondary outcome
Antitumor activity of RXDX-107 as measured by Objective Response Rate (ORR)
Time frame: Approx. 1 year
Results and safety
The study was stopped early (reason given: Company decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RXDX-107 in people with Solid Tumor, run by Hoffmann-La Roche at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Company decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Safety profile of RXDX-107 as characterized by Adverse Events, ECG and laboratory abnormalities (time frame: Approx. 1 year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2019.