Who is sponsoring NCT00521144?

NCT00521144 is sponsored by National Cancer Institute (NCI).

What drugs are being tested in NCT00521144?

Interventions in NCT00521144: obatoclax mesylate, topotecan hydrochloride, laboratory biomarker analysis.

What condition does NCT00521144 study?

NCT00521144 studies Recurrent Small Cell Lung Cancer, Unspecified Adult Solid Tumor, Protocol Specific.

Is NCT00521144 still recruiting?

NCT00521144 is currently completed. Last updated 14 April 2015.

Are results published for NCT00521144?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2015-04-14 · How we verify

NCT00521144

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

Phase I/II Study of Obatoclax Mesylate (GX15-070MS), a Bcl-2 Antagonist, Plus Topotecan in Relapsed Small Cell Lung Carcinoma

Completed Phase 1/Phase 2 Results posted Last updated 14 April 2015

What this trial tests

Phase 1/Phase 2 trial testing obatoclax mesylate in Recurrent Small Cell Lung Cancer in 22 participants. Completed in 1 August 2010.

Timeline

1 August 2007

Primary endpoint
1 August 2010

1 August 2010

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	22
Start date	1 August 2007
Primary completion	1 August 2010
Estimated completion	1 August 2010
Sites	2 locations across United States

Drugs / interventions tested

obatoclax mesylate — full drug profile →
topotecan hydrochloride — full drug profile →
laboratory biomarker analysis — full drug profile →

Conditions studied

Recurrent Small Cell Lung Cancer — all drugs for Recurrent Small Cell Lung Cancer →
Unspecified Adult Solid Tumor, Protocol Specific — all drugs for Unspecified Adult Solid Tumor, Protocol Specific →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Recurrent Small Cell Lung Cancer or Unspecified Adult Solid Tumor, Protocol Specific. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Overall Response Rate (Phase II)
Time frame: Every 6 weeks, assessed up to 30 days
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR +PR

Sponsor's own description

This phase I/II trial is studying the side effects and best dose of obatoclax mesylate when given together with topotecan hydrochloride and to see how well they work in treating patients with relapsed or refractory small cell lung cancer or advanced solid tumors. Obatoclax mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving obatoclax mesylate together with topotecan hydrochloride may help kill more tumor cells

Publications & conference data

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

A phase II study of obatoclax mesylate, a Bcl-2 antagonist, plus topotecan in relapsed small cell lung cancer.
Paik PK, Rudin CM, Pietanza MC, Brown A, et al · · 2011 · cited 72× · PMID 21620511 · DOI 10.1016/j.lungcan.2011.05.005
BH3-mimetics: recent developments in cancer therapy.
Townsend PA, Kozhevnikova MV, Cexus ONF, Zamyatnin AA, et al · · 2021 · cited 70× · PMID 34753495 · DOI 10.1186/s13046-021-02157-5
A multicenter phase I/II study of obatoclax mesylate administered as a 3- or 24-hour infusion in older patients with previously untreated acute myeloid leukemia.
Schimmer AD, Raza A, Carter TH, Claxton D, et al · · 2014 · cited 61× · PMID 25285531 · DOI 10.1371/journal.pone.0108694
Bcl-2 pathway inhibition in solid tumors: a review of clinical trials.
Ploumaki I, Triantafyllou E, Koumprentziotis IA, Karampinos K, et al · · 2023 · cited 60× · PMID 36639602 · DOI 10.1007/s12094-022-03070-9
Ionophores: Potential Use as Anticancer Drugs and Chemosensitizers.
Kaushik V, Yakisich JS, Kumar A, Azad N, et al · · 2018 · cited 58× · PMID 30262730 · DOI 10.3390/cancers10100360
Targeted therapies in small cell lung cancer: a review.
Abidin AZ, Garassino MC, Califano R, Harle A, et al · · 2010 · cited 36× · PMID 21789124 · DOI 10.1177/1758834009356014
Small cell lung cancer: emerging subtypes, signaling pathways, and therapeutic vulnerabilities.
Zhang J, Zeng X, Guo Q, Sheng Z, et al · · 2024 · cited 8× · PMID 39103941 · DOI 10.1186/s40164-024-00548-w
BCL-2 and BCL-xL in Cancer: Regulation, Function, and Therapeutic Targeting.
Silva JPN, Pinto B, Silva PMA, Bousbaa H. · · 2026 · cited 1× · PMID 41596764 · DOI 10.3390/ijms27021123

Verify or expand the search:

Other recruiting trials for Recurrent Small Cell Lung Cancer

Currently open trials in the same condition.

NCT06681220 — Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC · Phase 1, PHASE2 · 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 NCT00521144 (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: 14 April 2015

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/NCT00521144.

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