Who is sponsoring NCT01749397?

NCT01749397 is sponsored by National Cancer Institute (NCI).

What drugs are being tested in NCT01749397?

Interventions in NCT01749397: Floxuridine, Laboratory Biomarker Analysis, Pharmacological Study, Veliparib.

What condition does NCT01749397 study?

NCT01749397 studies Stage IV Fallopian Tube Cancer AJCC v6 and v7, Stage IV Ovarian Cancer AJCC v6 and v7, Stage IV Primary Peritoneal Cancer AJCC v7.

Is NCT01749397 still recruiting?

NCT01749397 is currently completed. Last updated 2 July 2020.

Last reviewed 2020-07-02 · How we verify

NCT01749397

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Veliparib and Floxuridine in Treating Patients With Metastatic Epithelial Ovarian, Primary Peritoneal Cavity, or Fallopian Tube Cancer

Completed Phase 1 Last updated 2 July 2020

What this trial tests

Phase 1 trial testing Floxuridine in Stage IV Fallopian Tube Cancer AJCC v6 and v7 in 29 participants. Completed in 21 November 2019.

Timeline

7 December 2012

Primary endpoint
20 October 2017

21 November 2019

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	29
Start date	7 December 2012
Primary completion	20 October 2017
Estimated completion	21 November 2019
Sites	5 locations across United States

Drugs / interventions tested

Floxuridine (FLOXURIDINE) — full drug profile →
Laboratory Biomarker Analysis — full drug profile →
Pharmacological Study — full drug profile →
Veliparib — full drug profile →

Conditions studied

Stage IV Fallopian Tube Cancer AJCC v6 and v7 — all drugs for Stage IV Fallopian Tube Cancer AJCC v6 and v7 →
Stage IV Ovarian Cancer AJCC v6 and v7 — all drugs for Stage IV Ovarian Cancer AJCC v6 and v7 →
Stage IV Primary Peritoneal Cancer AJCC v7 — all drugs for Stage IV Primary Peritoneal Cancer AJCC v7 →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, female only, with Stage IV Fallopian Tube Cancer AJCC v6 and v7 or Stage IV Ovarian Cancer AJCC v6 and v7. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial studies the side effects and best dose of veliparib when given together with floxuridine in treating patients with epithelial ovarian, primary peritoneal cavity, or fallopian tube cancer that has spread to other places in the body. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as floxuridine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving veliparib together with floxuridine may kill more tumor cells.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting DNA damage response in cancer therapy.
Hosoya N, Miyagawa K. · · 2014 · cited 232× · PMID 24484288 · DOI 10.1111/cas.12366
PARP inhibitors: Clinical utility and possibilities of overcoming resistance.
Bitler BG, Watson ZL, Wheeler LJ, Behbakht K. · · 2017 · cited 161× · PMID 29037806 · DOI 10.1016/j.ygyno.2017.10.003
Targeting DNA repair pathways for cancer treatment: what's new?
Kelley MR, Logsdon D, Fishel ML. · · 2014 · cited 143× · PMID 24947262 · DOI 10.2217/fon.14.60
Current status of poly(ADP-ribose) polymerase inhibitors and future directions.
Ohmoto A, Yachida S. · · 2017 · cited 96× · PMID 29138572 · DOI 10.2147/ott.s139336
An update on PARP inhibitors for the treatment of cancer.
Benafif S, Hall M. · · 2015 · cited 78× · PMID 25750544 · DOI 10.2147/ott.s30793
Current status and future prospects of PARP inhibitor clinical trials in ovarian cancer.
Jiang X, Li W, Li X, Bai H, et al · · 2019 · cited 75× · PMID 31191001 · DOI 10.2147/cmar.s200524
The Role of PARP Inhibitors in the Treatment of Gynecologic Malignancies.
Reinbolt RE, Hays JL. · · 2013 · cited 43× · PMID 24098868 · DOI 10.3389/fonc.2013.00237
Genomically Incorporated 5-Fluorouracil that Escapes UNG-Initiated Base Excision Repair Blocks DNA Replication and Activates Homologous Recombination.
Huehls AM, Huntoon CJ, Joshi PM, Baehr CA, et al · · 2016 · cited 42× · PMID 26494862 · DOI 10.1124/mol.115.100164

Verify or expand the search:

Other trials of Floxuridine

Trials testing the same drug.

NCT05863195 — Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Pa · Phase 3 · recruiting
NCT05286814 — PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Color · Phase 2 · recruiting
NCT03678428 — FUDR/Oxaliplatin HAI Plus Irinotecan vs. FOLFOXIRI Chemotherapy in Treating Initially Unresectable CRCLM · Phase 3 · terminated
NCT04251715 — mFOLFIRINOX Followed by Hepatic Arterial Infusion of Floxuridine and Dexamethasone With Systemic mFOLFIRI for Unresectab · Phase 2 · active not recruiting
NCT04552093 — Hepatic Arterial Infusion Pump Chemotherapy Combined With Systemic Chemotherapy (PUMP-IT) · Phase 2, PHASE3 · unknown

Other recruiting trials for Stage IV Fallopian Tube Cancer AJCC v6 and v7

Currently open trials in the same condition.

NCT02627443 — Carboplatin, Gemcitabine Hydrochloride, and Berzosertib in Treating Patients With Recurrent and Metastatic Ovarian, Prim · Phase 1 · active not recruiting
NCT02726997 — Matched Paired Pharmacodynamics and Feasibility Study of Durvalumab in Combination With Chemotherapy in Frontline Ovaria · Phase 1, PHASE2 · active not recruiting
NCT02659241 — Adavosertib Before Surgery in Treating Patients With Advanced High Grade Ovarian, Fallopian Tube, or Primary Peritoneal · EARLY_PHASE1 · active not recruiting
NCT02142803 — TORC1/2 Inhibitor MLN0128 and Bevacizumab in Treating Patients With Recurrent Glioblastoma or Advanced Solid Tumors · Phase 1 · active not recruiting
NCT01970722 — Surgery and Chemotherapy With or Without Chemotherapy After Surgery in Treating Patients With Ovarian, Fallopian Tube, U · Phase 1 · active not recruiting

Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

NCT07147231 — Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cem · Phase 1, PHASE2 · recruiting
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa · Phase 2 · recruiting
NCT07012044 — A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After · Phase 1 · not yet recruiting
NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01749397 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 2 July 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01749397.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing