RRx-001 in Lung Cancer, Ovarian Cancer and Neuroendocrine Tumors Prior to Re-administration of Platinum Based Doublet Regimens (QUADRUPLE THREAT)

Part of paid clinical trials in Palo Alto, California.

Sponsor
EpicentRx, Inc.
Study ID
NCT02489903
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RRx-001 — DRUG
  • Cisplatin — DRUG
  • Etoposide — DRUG
  • Carboplatin — DRUG
  • Irinotecan — DRUG
  • Vinorelbine — DRUG
  • Doxil — DRUG
  • Gemcitabine — DRUG
  • Taxane — DRUG
  • Paclitaxel — DRUG
  • Nab-Paclitaxel — DRUG
  • Pemetrexed — DRUG

Study Details

This study is designed to explore the potential of the epigenetic agent RRx-001 to sensitize patients who previously received and now have failed a platinum based doublet regimen. RRx-001 is administered with autologous blood once weekly followed by or in combination with reintroduction of platinum-based doublet therapy.

Key Dates

Start date
Jun 30, 2015
Status verified
Feb 2025
Primary completion
Dec 6, 2021
Completion
Dec 6, 2021

Study Design

Enrollment
139 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Small Cell Lung Cancer (Arm 1)
    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).
  • Active Comparator: Small Cell Lung Cancer (Arm 2)
    Carboplatin or cisplatin plus etoposide or irinotecan or vinorelbine until progression or intolerable toxicity
  • Experimental: Non Small Cell Lung Cancer
    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).
  • Experimental: Neuroendocrine tumors
    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).
  • Experimental: Ovarian epithelial cancer (Arm 1)
    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).
  • Active Comparator: Ovarian epithelial cancer (Arm 2)
    Carboplatin, Etoposide, Doxil, Gemcitabine or Vinorelbine or Taxane until progression or intolerable toxicity

Primary Outcome Measure

Overall Survival [ Time Frame: From start of treatment through death for up to 64 months from Start of Treatment. ]

Locations (10)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304-
VA Connecticut Cancer CenterWest HavenConnecticut06516-
Memorial Hospital of South BendSouth BendIndiana46601-
Baptist HealthLexingtonKentucky40503-
Walter Reed National Military Medical CenterBethesdaMaryland20889-
Henry Ford Allegiance HealthJacksonMichigan49201-
Washington UniversitySt LouisMissouri63110-
University of Cincinnati Cancer InstituteCincinnatiOhio45267-
Virginia Cancer SpecialistsFairfaxVirginia22031-
West Virginia UniversityMorgantownWest Virginia26506-

Find similar trials in Palo Alto, CA

By condition
Neuroendocrine tumors
By specialty
Oncology
By research site
Stanford University· Palo Alto, CAVA Connecticut Cancer Center· West Haven, CTMemorial Hospital of South Bend· South Bend, INBaptist Health· Lexington, KYWalter Reed National Military Medical Center· Bethesda, MDHenry Ford Allegiance Health· Jackson, MI

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