← Back to Search

Epigenetic Agent

RRx-001 for Neuroendocrine Tumors

Phase 2

Waitlist Available

Research Sponsored by EpicentRx, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to one year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, RRx-001, given with the patient's own blood and followed by standard chemotherapy. It targets patients with certain cancers who did not respond to previous treatments. The drug works by making cancer cells more sensitive to chemotherapy.

Eligible Conditions

Neuroendocrine Tumors
Small Cell Carcinoma
Non-Small Cell Lung Cancer
Ovarian Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival

Secondary study objectives

Disease Control Rate (DCR)

Overall Response Rate (ORR)

Progression Free Survival (PFS)

Side effects data

From 2020 Phase 2 trial • 62 Patients • NCT02096354

42%

Fatigue

34%

Infusion related reaction

32%

Diarrhea

24%

Abdominal pain

24%

Vomiting

18%

Disease progression

18%

Back Pain

16%

Hypertension

16%

Urinary tract infection

16%

Insomnia

16%

Constipation

13%

Tachycardia

11%

Hyponatraemia

11%

Hypokalaemia

11%

Anxiety

11%

Metastases to liver

11%

Small intestinal obstruction

Dyspnoea

Anemia

Tumour pseudoprogression

Pneumonia

Enterovesical fistula

Liver function test abnormal

Depression

Night sweats

Hypercoagulability

Ascites

Rectal haemorrhage

Infection

Pleural effusion

Malignant pleural effusion

Systemic inflammatory response syndrome

Acute kidney injury

Nausea

Influenza

Hyperglycemia

Hepatic encephalopathy

Acute Renal Failure

Spinal fracture

Iron deficiency anaemia

Arthralgia

Anaemia

Intestinal obstruction

Hydrocephalus

Delirium

Mental status changes

Myocardial infarction

Dehydration

Biliary sepsis

Acute hepatic failure

Bronchial Obstruction

Bacteraemia

100%

80%

60%

40%

20%

Study treatment Arm

RRx-001 Followed by Irinotecan

Regorafenib Followed by Irinotecan

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: Small Cell Lung Cancer (Arm 1)Experimental Treatment4 Interventions

RRx-001 weekly for 3 weeks followed by up to 4 cycles of carboplatin or cisplatin plus etoposide and then RRx-001 and carboplatin or cisplatin (for patients with stable disease (SD) or better at discontinuation of platinum).

Group II: Ovarian epithelial cancer (Arm 1)Experimental Treatment2 Interventions

RRx-001 weekly for 2 weeks followed by 2 cycles of Carboplatin chemotherapy and then RRx-001/Carboplatin maintenance (for patients with stable disease or better at discontinuation of platinum).

Group III: Non Small Cell Lung CancerExperimental Treatment6 Interventions

RRx-001 weekly for 3 weeks followed by up to 6 cycles of cisplatin or carboplatin plus paclitaxel or nab-paclitaxel or pemetrexed and then RRx-001 maintenance (for patients with stable disease or better at discontinuation of platinum).

Group IV: Neuroendocrine tumorsExperimental Treatment4 Interventions

RRx-001 weekly until progression followed by up to 6 cycles of carboplatin or cisplatin plus etoposide and then RRx-001 maintenance (for patients with stable disease or better at discontinuation of platinum).

Group V: Ovarian epithelial cancer (Arm 2)Active Control6 Interventions

Carboplatin, Etoposide, Doxil, Gemcitabine or Vinorelbine or Taxane until progression or intolerable toxicity

Group VI: Small Cell Lung Cancer (Arm 2)Active Control5 Interventions

Carboplatin or cisplatin plus etoposide or irinotecan or vinorelbine until progression or intolerable toxicity

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Etoposide

2010

Completed Phase 3

~2960