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NCT00576654
Veliparib and Irinotecan Hydrochloride in Treating Patients With Cancer That Is Metastatic or Cannot Be Removed by Surgery
Phase 1 trial testing Irinotecan Hydrochloride in Advanced Malignant Solid Neoplasm in 73 participants. Completed in 16 January 2020.
16 January 2020
Quick facts
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 73 |
| Start date | 18 March 2008 |
| Primary completion | 16 January 2020 |
| Estimated completion | 16 January 2020 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- Irinotecan Hydrochloride (Irinotecan Hydrochloride) — full drug profile →
- Laboratory Biomarker Analysis — full drug profile →
- Pharmacological Study — full drug profile →
- Veliparib — full drug profile →
Conditions studied
- Advanced Malignant Solid Neoplasm — all drugs for Advanced Malignant Solid Neoplasm →
- Metastatic Malignant Solid Neoplasm — all drugs for Metastatic Malignant Solid Neoplasm →
- Triple-Negative Breast Carcinoma — all drugs for Triple-Negative Breast Carcinoma →
- Unresectable Solid Neoplasm — all drugs for Unresectable Solid Neoplasm →
Sponsor
National Cancer Institute (NCI)
Who can join
18 and older, any sex, with Advanced Malignant Solid Neoplasm or Metastatic Malignant Solid Neoplasm. 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 irinotecan hydrochloride in treating patients with cancer that has spread to other parts of the body or that cannot be removed by surgery. Irinotecan hydrochloride can kill cancer cells by damaging the deoxyribonucleic acid (DNA) that is needed for cancer cell survival and growth. Veliparib may block proteins that repair the damaged DNA and may help irinotecan hydrochloride to kill more tumor cells. Giving irinotecan hydrochloride together with veliparib may kill more cancer cells.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Insights into Molecular Classifications of Triple-Negative Breast Cancer: Improving Patient Selection for Treatment.
Garrido-Castro AC, Lin NU, Polyak K. · · 2019 · cited 1061× · PMID 30679171 · DOI 10.1158/2159-8290.cd-18-1177 -
Targeting DNA damage response in cancer therapy.
Hosoya N, Miyagawa K. · · 2014 · cited 232× · PMID 24484288 · DOI 10.1111/cas.12366 -
PARP inhibitors in pancreatic cancer: molecular mechanisms and clinical applications.
Zhu H, Wei M, Xu J, Hua J, et al · · 2020 · cited 203× · PMID 32122376 · DOI 10.1186/s12943-020-01167-9 -
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: Current Understanding and Future Therapeutic Breakthrough Targeting Cancer Stemness.
Lee KL, Kuo YC, Ho YS, Huang YH. · · 2019 · cited 164× · PMID 31505803 · DOI 10.3390/cancers11091334 -
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 -
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 -
Promise and limits of the CellSearch platform for evaluating pharmacodynamics in circulating tumor cells.
Wang L, Balasubramanian P, Chen AP, Kummar S, et al · · 2016 · cited 98× · PMID 27663478 · DOI 10.1053/j.seminoncol.2016.06.004
Verify or expand the search:
- PubMed search for NCT00576654
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials testing the same drug.
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Other recruiting trials for Advanced Malignant Solid Neoplasm
Currently open trials in the same condition.
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Other National Cancer Institute (NCI) trials
Trials by the same sponsor.
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- 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)
- Trial protocol + status: ClinicalTrials.gov NCT00576654 (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: 15 April 2025
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