XRD-0394 for Metastasis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Memorial Sloan Kettering Cancer Center, New York, NY
Metastasis+3 More
XRD-0394 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called XRD-0394 can be safely given with palliative radiotherapy to people with cancer.

See full description

Eligible Conditions

  • Metastasis
  • Locally Advanced Solid Tumors
  • Recurrent Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Metastasis

Study Objectives

This trial is evaluating whether XRD-0394 will improve 2 primary outcomes and 8 secondary outcomes in patients with Metastasis. Measurement will happen over the course of Day 2 of RT regimen.

Day 28
Number of subjects experiencing treatment-emergent adverse events (TEAE), serious TEAEs, TEAEs leading to discontinuation of RT, and TEAEs leading to death
Number of subjects with at least 1 dose-limiting toxicity (DLT)
Day 5
Change in radiation-induced phosphorylated Krüppel-associated box domain (KRAB)-associated protein 1 (pKAP1) in tumor biopsy samples
Day 2
Identification of dose(s) of XRD-0394 that achieve concentrations within protocol-specified range
Day 5
Determination of area under the plasma concentration versus time curve from zero to infinity (AUC0-∞) after a single dose of XRD-0394
Determination of area under the plasma concentration versus time curve from zero to the last sampling time (AUC0-t) after a single dose of XRD-0394
Determination of maximum plasma concentration (Cmax) after a single dose of XRD-0394
Determination of plasma concentrations at 1 to 4 hours post-dose after a single dose of XRD-0394
Determination of terminal half-life (t1/2) after a single dose of XRD-0394
Determination of time to maximum plasma concentration (tmax) after a single dose of XRD-0394

Trial Safety

Safety Progress

1 of 3

Other trials for Metastasis

Trial Design

4 Treatment Groups

XRD-0394 (Dose TBD)
1 of 4
XRD-0394 160 mg
1 of 4
XRD-0394 80 mg
1 of 4
XRD-0394 40 mg
1 of 4
Experimental Treatment

This trial requires 38 total participants across 4 different treatment groups

This trial involves 4 different treatments. XRD-0394 is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

XRD-0394 (Dose TBD)Subjects will receive a single dose of XRD-0394 capsules approximately 90 minutes before RT. A single biopsy will be performed in each subject (either after RT alone or after XRD-0394 and RT).
XRD-0394 160 mgSubjects will receive a single dose of XRD-0394 capsules approximately 90 minutes before RT on Day 2 of the RT regimen
XRD-0394 80 mgSubjects will receive a single dose of XRD-0394 capsules approximately 90 minutes before RT on Day 2 of the RT regimen
XRD-0394 40 mgSubjects will receive a single dose of XRD-0394 capsules approximately 90 minutes before RT on Day 2 of the RT regimen
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palliative radiotherapy
2015
Completed Phase 2
~10

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 28 days post-completion of rt
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 28 days post-completion of rt for reporting.

Closest Location

Memorial Sloan Kettering Cancer Center - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Metastasis or one of the other 3 conditions listed above. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Subcutaneous or soft tissue
Histologically confirmed diagnosis of cancer with clear evidence of metastasis on imaging. Subjects with locally advanced or recurrent (non-metastatic) cancer for whom palliative RT is indicated may also be enrolled.
Scheduled to receive palliative RT delivered as 4 Gray × 5 daily fractions at the discretion of the treating radiation oncologist. The radiation plan should be designed to optimally limit the radiation dose delivered to normal tissues using conformal treatment plans and protocol-specified limits.
Skin
Any other site that will allow the radiation dose to normal structures to remain within protocol-specified dosing limits.
Male or female subjects at least 18 years of age who are willing and able to provide written informed consent.
Other protocol-defined criteria may apply
Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.

Patient Q&A Section

Can relapse be cured?

"Relapse after successful treatment is a rare event for patients; therefore, it is not a reliable predictor of future disease relapse. In patients with severe disease, it is of critical importance to identify their risk factors that precipitate relapse." - Anonymous Online Contributor

Unverified Answer

What are the signs of relapse?

"There are no signs of relapse such as fever, night sweats, weight loss or feeling tired for more than two weeks when the patient is taking antipsychotics appropriately. There will be a significant improvement after the initial exacerbation." - Anonymous Online Contributor

Unverified Answer

What is relapse?

"Although inpatient wards offer significant benefits in preventing relapse, our study provides evidence that a'real world' situation would prove to be a superior 'control' context for studying the impact of preventive treatments." - Anonymous Online Contributor

Unverified Answer

How many people get relapse a year in the United States?

"Around 18% of patients with first episode depression are likely to relapse within 1 year. If the recurrence is moderate, around 3-4% of relapse patients are likely to relapse within 1 year. Recent findings suggest that relapse is more common in moderate/severe depression than in major depression." - Anonymous Online Contributor

Unverified Answer

What causes relapse?

"Many patients with mood disorders have adverse life events during periods of protracted symptoms. For patients in remission it may be helpful to have periodic reassessments to allow preventive measures to be instituted early upon detection of a recurrence." - Anonymous Online Contributor

Unverified Answer

What are common treatments for relapse?

"Treatment of relapse occurs in the first year following the definitive diagnosis of cancer with most treatments. Current recommendations include chemotherapy based on disease-specific prognostic indicators. Relapse occurs in the majority of patients two years after diagnosis, with half of those patients achieving remission in the interim period." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving xrd-0394?

"Xrd-0394 has been evaluated in the treatment of several types of solid tumors. Recent findings indicates that patients whose disease were responsive to xrd-0394 (that is, disease-free) had a better prognosis than those who were not responsive to xrd-0394. The drug is currently being evaluated in clinical trials for relapsed/refractory Hodgkin lymphoma, solid tumors, and cutaneous lesions. As with other small-molecule inhibitors of retinoic acid, there are risk factors for cardiovascular events associated with xrd-0394 that need to be assessed at the start of the trials." - Anonymous Online Contributor

Unverified Answer

What is xrd-0394?

"In a clinical trial for CTCL, XRD-0394 was well tolerated with no clinically relevant drug-drug interactions. Additionally, significant suppression of peripheral blood NK cells (CD16+CD57+) with XRD-0394 was observed within 3 months of treatment, consistent with the hypothesis that inhibition of NK cells might be the mechanism of action. Based on these findings, clinical trials with XRD-0394, including both single-agent and combination regimens, are in the planning stages for CTCL." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of xrd-0394?

"XRD-0394 is well tolerated. It has a promising pharmacokinetic profile. Mild adverse effects including diarrhea, nausea, headache; and fatigue are most frequently observed. Further studies are needed to establish a precise adverse effect mechanism, and potential clinical effect, of this agent." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in xrd-0394 for therapeutic use?

"Xrd-0394 significantly enhances the anti-cancer effect of cisplatin, and this effect is achieved with the lowest possible dose, suggesting that xrd-0394 may be used instead of cisplatin as a first-line cancer regimen in patients with a poor survival. Xrd-0394 is effective even in advanced disease because of a good response to this drug in the treatment of metastatic disease." - Anonymous Online Contributor

Unverified Answer

How does xrd-0394 work?

"Data from a recent study support our hypothesis that xrd-0394 causes an increased amount of XBP1 mRNA, which then causes the transcription factor to bind to the E-box sequence. Once bound to the E-box sequence, XBP1 will then bind to and promote transcription of the XBP-1 gene, which then begins the response to xrd-0394. In a subset of L-cells, xrd-0394 can also induce apoptosis through the modulation of caspases." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for relapse?

"In the last 6 months, one-fifth of the patients who responded to anti-TNFα therapy had a relapse. Clinical trials for relapse were more likely to be eligible for low-risk/low-fat/low-calorie diets, but few of the patients who were eligible for a trial were aware of it and did it. Clinicians may wish to consider conducting a clinical trial for relapse when patients meet these criteria." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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