Who is sponsoring NCT00535353?

NCT00535353 is sponsored by NCIC Clinical Trials Group.

What drugs are being tested in NCT00535353?

Interventions in NCT00535353: irinotecan hydrochloride, olaparib.

What condition does NCT00535353 study?

NCT00535353 studies Colorectal Cancer.

Is NCT00535353 still recruiting?

NCT00535353 is currently completed. Last updated 4 August 2023.

Last reviewed 2023-08-04 · How we verify

NCT00535353

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

AZD2281 and Irinotecan in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer

Completed Phase 1 Last updated 4 August 2023

What this trial tests

Phase 1 trial testing irinotecan hydrochloride in Colorectal Cancer in 26 participants. Completed in 13 February 2015.

Timeline

2 January 2008

Primary endpoint
25 September 2012

13 February 2015

Quick facts

Lead sponsor	NCIC Clinical Trials Group
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	26
Start date	2 January 2008
Primary completion	25 September 2012
Estimated completion	13 February 2015
Sites	2 locations across Canada

Drugs / interventions tested

irinotecan hydrochloride (Irinotecan Hydrochloride) — full drug profile →
olaparib (olaparib) — full drug profile →

Conditions studied

Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

NCIC Clinical Trials Group

Who can join

Adults 18 to 70, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

RATIONALE: AZD2281 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving AZD2281 together with irinotecan may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of AZD2281 and irinotecan in treating patients with locally advanced or metastatic colorectal cancer.

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
Dancing with the DNA damage response: next-generation anti-cancer therapeutic strategies.
Minchom A, Aversa C, Lopez J. · · 2018 · cited 97× · PMID 30023007 · DOI 10.1177/1758835918786658
Microenvironmental Reactive Oxygen Species in Colorectal Cancer: Involved Processes and Therapeutic Opportunities.
Sorolla MA, Hidalgo I, Sorolla A, Montal R, et al · · 2021 · cited 42× · PMID 34680186 · DOI 10.3390/cancers13205037
A Phase I study of olaparib and irinotecan in patients with colorectal cancer: Canadian Cancer Trials Group IND 187.
Chen EX, Jonker DJ, Siu LL, McKeever K, et al · · 2016 · cited 42× · PMID 27075016 · DOI 10.1007/s10637-016-0351-x
Targeting the DNA Damage Response and DNA Repair Pathways to Enhance Radiosensitivity in Colorectal Cancer.
Deng S, Vlatkovic T, Li M, Zhan T, et al · · 2022 · cited 40× · PMID 36230796 · DOI 10.3390/cancers14194874
Inhibition of DNA Repair in Cancer Therapy: Toward a Multi-Target Approach.
Lodovichi S, Cervelli T, Pellicioli A, Galli A. · · 2020 · cited 34× · PMID 32932697 · DOI 10.3390/ijms21186684
Poly(Adenosine diphosphate-ribose) polymerase inhibitors in cancer treatment.
Park SR, Chen A. · · 2012 · cited 23× · PMID 22520984 · DOI 10.1016/j.hoc.2012.02.012

Verify or expand the search:

Other trials of irinotecan hydrochloride

Trials testing the same drug.

NCT02049593 — PARP Inhibitor BMN-673 and Temozolomide or Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metast · Phase 1 · completed
NCT02047474 — Combination Chemotherapy Before and After Surgery in Treating Patients With Localized Pancreatic Cancer · Phase 2 · completed
NCT01814501 — Panitumumab and Chemotherapy in Patients With Advanced Colorectal Cancer After Prior Therapy With Bevacizumab · Phase 2 · completed
NCT01079780 — Irinotecan Hydrochloride and Cetuximab With or Without Ramucirumab in Treating Patients With Advanced Colorectal Cancer · Phase 2 · completed
NCT00614393 — Study of Dalotuzumab (MK-0646) in Combination With Cetuximab and Irinotecan in Metastatic Colorectal Cancer (MK-0646-004 · Phase 2 · completed

Other recruiting trials for Colorectal Cancer

Currently open trials in the same condition.

NCT07152821 — Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcino · Phase 3 · recruiting
NCT07353645 — KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer · Phase 1, PHASE2 · recruiting
NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
NCT07523919 — Functional and Respiratory Determinants of Long-Term Colorectal Cancer Outcomes · recruiting
NCT07529301 — Functional and Respiratory Predictors of Early Postoperative Outcomes · recruiting

Other NCIC Clinical Trials Group trials

Trials by the same sponsor.

NCT01916187 — Imetelstat Given Intravenously Alone and With Standard 13-Cis-Retinoic Acid in Children With Neuroblastoma · Phase 1 · withdrawn
NCT01830621 — BBI608 and Best Supportive Care vs Placebo and Best Supportive Care in Pretreated Advanced Colorectal Carcinoma · Phase 3 · completed
NCT01652144 — A Phase II Study of AT7519M, a CDK Inhibitor, in Patients With Relapsed Mantle Cell Lymphoma · Phase 2 · completed
NCT01627054 — A Phase II Study of AT7519M, a CDK Inhibitor, in Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia · Phase 2 · completed
NCT01486368 — A Phase II Study of PF-03446962 in Patients With Advanced Malignant Pleural Mesothelioma · Phase 2 · completed

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 NCT00535353 (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 NCIC Clinical Trials Group
Last refreshed: 4 August 2023

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/NCT00535353.

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