Who is sponsoring NCT01145430?

NCT01145430 is sponsored by National Cancer Institute (NCI).

What drugs are being tested in NCT01145430?

Interventions in NCT01145430: Laboratory Biomarker Analysis, Pegylated Liposomal Doxorubicin Hydrochloride, Pharmacological Study, Veliparib.

What condition does NCT01145430 study?

NCT01145430 studies Estrogen Receptor Negative, HER2/Neu Negative, Male Breast Carcinoma, Progesterone Receptor Negative, Recurrent Breast Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Stage IV Breast Cancer AJCC v6 and v7, Triple-Negative Breast Carcinoma.

Is NCT01145430 still recruiting?

NCT01145430 is currently completed. Last updated 22 December 2017.

Last reviewed 2017-12-22 · How we verify

NCT01145430

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

Veliparib and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer or Metastatic Breast Cancer

Completed Phase 1 Last updated 22 December 2017

What this trial tests

Phase 1 trial testing Laboratory Biomarker Analysis in Estrogen Receptor Negative in 45 participants. Completed.

Timeline

1 June 2010

Primary endpoint
23 May 2017

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	45
Start date	1 June 2010
Primary completion	23 May 2017
Sites	6 locations across United States

Drugs / interventions tested

Laboratory Biomarker Analysis — full drug profile →
Pegylated Liposomal Doxorubicin Hydrochloride — full drug profile →
Pharmacological Study — full drug profile →
Veliparib — full drug profile →

Conditions studied

Estrogen Receptor Negative — all drugs for Estrogen Receptor Negative →
HER2/Neu Negative — all drugs for HER2/Neu Negative →
Male Breast Carcinoma — all drugs for Male Breast Carcinoma →
Progesterone Receptor Negative — all drugs for Progesterone Receptor Negative →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Estrogen Receptor Negative or HER2/Neu Negative. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial studies the side effects and the best dose of veliparib when given together with pegylated liposomal doxorubicin hydrochloride in treating patients with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has come back after a period of improvement, or breast cancer that has spread to other parts of 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 liposomal doxorubicin hydrochloride, 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 liposomal doxorubicin hydrochloride 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
Harnessing synthetic lethal interactions in anticancer drug discovery.
Chan DA, Giaccia AJ. · · 2011 · cited 195× · PMID 21532565 · DOI 10.1038/nrd3374
Triple-negative breast cancer and the potential for targeted therapy.
Jhan JR, Andrechek ER. · · 2017 · cited 155× · PMID 29095114 · DOI 10.2217/pgs-2017-0117
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
A Review of Systemic Treatment in Metastatic Triple-Negative Breast Cancer.
Zeichner SB, Terawaki H, Gogineni K. · · 2016 · cited 134× · PMID 27042088 · DOI 10.4137/bcbcr.s32783
Role of PARP inhibitors in cancer biology and therapy.
Davar D, Beumer JH, Hamieh L, Tawbi H. · · 2012 · cited 90× · PMID 22788767 · DOI 10.2174/092986712802002464
Advances and perspectives of PARP inhibitors.
Yi M, Dong B, Qin S, Chu Q, et al · · 2019 · cited 83× · PMID 31737426 · DOI 10.1186/s40164-019-0154-9
An update on PARP inhibitors for the treatment of cancer.
Benafif S, Hall M. · · 2015 · cited 78× · PMID 25750544 · DOI 10.2147/ott.s30793

Verify or expand the search:

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Trials testing the same drug.

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Other recruiting trials for Estrogen Receptor Negative

Currently open trials in the same condition.

NCT02945579 — Multicenter Trial for Eliminating Breast Cancer Surgery or Radiotherapy in Exceptional Responders to Neoadjuvant Systemi · NA · recruiting
NCT02744053 — DCE-MRI and MBI in Assessing Tumor Response to Chemotherapy in Patients With Triple Negative Breast Cancer · EARLY_PHASE1 · active not recruiting
NCT02876107 — Carboplatin and Paclitaxel With or Without Panitumumab in Treating Patients With Invasive Triple Negative Breast Cancer · Phase 2 · active not recruiting
NCT02432963 — Vaccine Therapy and Pembrolizumab in Treating Patients With Solid Tumors That Have Failed Prior Therapy · Phase 1 · active not recruiting
NCT02445391 — Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy · Phase 3 · 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 NCT01145430 (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: 22 December 2017

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/NCT01145430.

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