Who is sponsoring NCT00588991?

NCT00588991 is sponsored by National Cancer Institute (NCI).

What drugs are being tested in NCT00588991?

Interventions in NCT00588991: Carboplatin, Laboratory Biomarker Analysis, Topotecan Hydrochloride, Veliparib.

What condition does NCT00588991 study?

NCT00588991 studies Adult Acute Megakaryoblastic Leukemia, Adult Acute Monoblastic Leukemia, Adult Acute Monocytic Leukemia, Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With Maturation, Adult Acute Myeloid Leukemia With Minimal Differentiation, Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1, Adult Acute Myeloid Leukemia With t(9;11)(p21.3;q23.3); MLLT3-KMT2A, Adult Acute Myeloid Leukemia Without Maturation, Adult Acute Myelomonocytic Leukemia, Adult Erythroleukemia, Adult Pure Erythroid Leukemia, Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive, Chronic Myelomonocytic Leukemia, De Novo Myelodysplastic Syndrome, Essential Thrombocythemia, Hematopoietic and Lymphoid Cell Neoplasm, Myelodysplastic Syndrome, Polycythemia Vera, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Secondary Myelodysplastic Syndrome.

Is NCT00588991 still recruiting?

NCT00588991 is currently completed. Last updated 2 April 2025.

Last reviewed 2025-04-02 · How we verify

NCT00588991

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

Veliparib and Topotecan With or Without Carboplatin in Treating Patients With Relapsed or Refractory Acute Leukemia, High-Risk Myelodysplasia, or Aggressive Myeloproliferative Disorders

Completed Phase 1 Last updated 2 April 2025

What this trial tests

Phase 1 trial testing Carboplatin in Adult Acute Megakaryoblastic Leukemia in 12 participants. Completed in 16 November 2016.

Timeline

4 February 2008

Primary endpoint
1 November 2016

16 November 2016

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	12
Start date	4 February 2008
Primary completion	1 November 2016
Estimated completion	16 November 2016
Sites	2 locations across United States

Drugs / interventions tested

Carboplatin (Carboplatin) — full drug profile →
Laboratory Biomarker Analysis — full drug profile →
Topotecan Hydrochloride — full drug profile →
Veliparib — full drug profile →

Conditions studied

Adult Acute Megakaryoblastic Leukemia — all drugs for Adult Acute Megakaryoblastic Leukemia →
Adult Acute Monoblastic Leukemia — all drugs for Adult Acute Monoblastic Leukemia →
Adult Acute Monocytic Leukemia — all drugs for Adult Acute Monocytic Leukemia →
Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11 — all drugs for Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11 →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Adult Acute Megakaryoblastic Leukemia or Adult Acute Monoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial is studying the side effects and best dose of veliparib when given together with topotecan hydrochloride with or without carboplatin in treating patients with relapsed or refractory acute leukemia, high-risk myelodysplasia, or aggressive myeloproliferative disorders. Veliparib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as topotecan hydrochloride and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving veliparib together with topotecan hydrochloride and carboplatin may kill more cancer 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
Combination Platinum-based and DNA Damage Response-targeting Cancer Therapy: Evolution and Future Directions.
Basourakos SP, Li L, Aparicio AM, Corn PG, et al · · 2017 · cited 91× · PMID 27978798 · DOI 10.2174/0929867323666161214114948
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
Targeting PARP proteins in acute leukemia: DNA damage response inhibition and therapeutic strategies.
Padella A, Ghelli Luserna Di Rorà A, Marconi G, Ghetti M, et al · · 2022 · cited 73× · PMID 35065680 · DOI 10.1186/s13045-022-01228-0
Advances in biology of acute lymphoblastic leukemia (ALL) and therapeutic implications.
Mohseni M, Uludag H, Brandwein JM. · · 2018 · cited 34× · PMID 30697448
PARP Inhibitors and Myeloid Neoplasms: A Double-Edged Sword.
Csizmar CM, Saliba AN, Swisher EM, Kaufmann SH. · · 2021 · cited 33× · PMID 34945003 · DOI 10.3390/cancers13246385
Inhibitors of Chemoresistance Pathways in Combination with Ara-C to Overcome Multidrug Resistance in AML. A Mini Review.
Fajardo-Orduña GR, Ledesma-Martínez E, Aguiñiga-Sánchez I, Mora-García ML, et al · · 2021 · cited 27× · PMID 34066940 · DOI 10.3390/ijms22094955

Verify or expand the search:

Other trials of Carboplatin

Trials testing the same drug.

NCT04832438 — 9-ING-41 Plus Carboplatin in Patients With Advanced, Metastatic Salivary Gland Carcinoma · Phase 2 · withdrawn
NCT07229339 — Zipalertinib With Carboplatin and Pemetrexed for the Treatment of Resectable, Stage II-IIIB, Non-Small Cell Lung Cancer · Phase 2 · not yet recruiting
NCT07346196 — A Trial of Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck · Phase 2 · not yet recruiting
NCT07441681 — Comparing Radiation Plus Cetuximab to Radiation Plus Chemotherapy in People With Head and Neck Cancer Who Cannot Receive · Phase 3 · not yet recruiting
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa · Phase 2 · recruiting

Other recruiting trials for Adult Acute Megakaryoblastic Leukemia

Currently open trials in the same condition.

NCT00658814 — Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia · Phase 2 · 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 NCT00588991 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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 April 2025

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/NCT00588991.

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