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

69%

Anorexia

62%

Pain in Extremity

62%

Erythema

54%

Fatigue

54%

Rash maculo-papular

46%

Headache

46%

Abdominal pain

31%

Hyperbilirubinaemia

31%

Aspartate aminotransferase increased

31%

Back Pain

31%

Palmar-plantar erythrodysaethesia syndrome

31%

Hypertension

31%

Mucositis oral

23%

Blood bilirubin increased

15%

Urinary tract infection

15%

Disease progression

15%

Alanine aminotransferase increased

15%

Blood alkaline phosphatase increased

15%

Dyspnoea

15%

Night sweats

15%

Vomiting

15%

Anemia

Ataxia

Hydronephrosis

Haemoptysis

Drug Eruption

Intestinal obstruction

Stomatitis

Spinal fracture

Hypokalaemia

Hyponatraemia

Arthralgia

Groin Pain

Anxiety

Insomnia

Tachycardia

Ascites

Diarrhea

AV Malformations

Abdominal Pain lower

Constipation

Mental status changes

Lower Gastrointestinal haemorrhage

Flank pain

100%

80%

60%

40%

20%

Study treatment Arm

Regorafenib Followed by Irinotecan

RRx-001 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