TH-302

DRUG16 trials

Sponsors

Threshold Pharmaceuticals, ImmunoGenesis, Merck KGaA, Darmstadt, Germany, The University of Texas Health Science Center at San Antonio, Maastricht Radiation Oncology

Conditions

Acute Lymphoblastic LeukemiaAcute Myelogenous LeukemiaAdvanced MyelofibrosisAdvanced Renal Cell CarcinomaChronic Lymphocytic LeukemiaChronic Myelogenous LeukemiaEsophageal CancerGastrointestinal Stromal Tumors

Phase 1

A Phase I Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of TH-302 in Patients With Advanced Solid Tumors

CompletedNCT00495144

Threshold PharmaceuticalsHypoxia, Tumors

Start: 2007-06-30End: 2012-06-30Updated: 2012-07-27

Dose-Escalation Study of TH-302 in Combination With Doxorubicin to Treat Patients With Advanced Soft Tissue Sarcoma

CompletedNCT00742963

ImmunoGenesisSoft Tissue Sarcoma

Start: 2008-08-31End: 2013-10-31Updated: 2025-05-13

Dose-Escalation Study of TH-302 in Combination With A) Gemcitabine or B) Docetaxel or C) Pemetrexed to Treat Advanced Solid Tumors

CompletedNCT00743379

Threshold PharmaceuticalsNon-Small Cell Lung Cancer, Pancreatic Cancer, Prostate Cancer

Start: 2008-08-31End: 2014-03-31Updated: 2015-05-07

Study of Hypoxia-Activated Prodrug TH-302 to Treat Advanced Leukemias

CompletedNCT01149915

Threshold PharmaceuticalsAcute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Advanced Myelofibrosis +3

Start: 2010-06-30End: 2013-08-31Target: 40Updated: 2015-05-07

Dose-Escalation Study of TH-302 in Combination With Sunitinib to Treat Patients With Advanced Renal Cell Carcinoma,Gastrointestinal Stromal Tumors and Pancreatic Neuroendocrine Tumors

Threshold PharmaceuticalsAdvanced Renal Cell Carcinoma, Gastrointestinal Stromal Tumors, Pancreatic Neuroendocrine Tumors

Start: 2011-06-30End: 2014-06-30Target: 58Updated: 2014-04-21

Open-label Study of TH-302 and Dexamethasone With or Without Bortezomib or Pomalidomide in Subjects With Relapsed/Refractory Multiple Myeloma

Threshold PharmaceuticalsMultiple Myeloma

Start: 2012-02-29End: 2017-09-30Target: 98Updated: 2016-06-02

A Cardiac Safety Study of TH-302 in Patients With Advanced Solid Tumors

Threshold PharmaceuticalsSolid Tumors

Start: 2013-11-30End: 2016-12-31Target: 40Updated: 2016-06-02

Phase I TH-302 Plus Gemcitabine Plus Nab-Paclitaxel in Pancreatic Cancer

TerminatedNCT02047500

ImmunoGenesisPancreatic Cancer

Start: 2014-01-31End: 2016-05-31Updated: 2025-05-11

Testing TH-302, in Combination With Preoperative Chemoradiotherapy, in Esophageal Cancer.

WithdrawnNCT02598687

Maastricht Radiation OncologyEsophageal Cancer

Start: 2015-12-31End: 2016-04-30Updated: 2016-04-21

Phase 2

Study of the Safety and Efficacy of TH-302 in Combination With Gemcitabine Compared With Gemcitabine Alone in Previously Untreated Patients With Pancreatic Adenocarcinoma

CompletedNCT01144455

ImmunoGenesisPancreatic Adenocarcinoma

Start: 2010-06-30End: 2014-12-31Updated: 2025-05-11

A Phase 2 Biomarker - Enriched Study of TH-302 in Subjects With Advanced Melanoma

TerminatedNCT01864538

ImmunoGenesisMetastatic Melanoma

Start: 2013-05-31End: 2015-09-30Updated: 2025-05-11

A Japanese Trial of TH-302 in Subjects With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma

TerminatedNCT02255110

Merck KGaA, Darmstadt, GermanySoft Tissue Sarcoma

Start: 2014-12-10End: 2016-01-12Updated: 2018-12-14

TH-302 in Combination With Bevacizumab for Glioblastoma

CompletedNCT02342379

The University of Texas Health Science Center at San AntonioGlioblastoma

Start: 2015-05-31End: 2019-12-04Updated: 2020-04-10

Phase 3

Clinical Trial Testing TH-302 in Combination With Gemcitabine in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma

CompletedNCT01746979

ImmunoGenesisMetastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma

Start: 2012-12-31End: 2016-05-31Updated: 2025-05-11

Unknown Phase

A phase I trial testing TH-302, a tumor-selective Hypoxia-Activated cytotoxic Prodrug, in combination with preoperative chemoradiotherapy in patients with distal esophageal and esophago-gastric junction adenocarcinoma

Medisch Universitair Ziekenhuis Maastrichtesophageal cancer

Target: 18Updated: 2024-02-28

SARC021C: A Continuation Study of TH-CR-406/SARC021

Sarcoma Alliance for Research through CollaborationSoft Tissue Sarcoma

Updated: 2016-10-13

Related Papers

Unexpected pharmacokinetics of evofosfamide observed in phase III MAESTRO study.

Journal of Clinical Oncology2018-05-2015 citations

Assessment of tumor hypoxia in BEV resistant GBM using FMISO <sup>18</sup>F-PET and MRI.

Journal of Clinical Oncology2017-05-201 citations

A phase 1 'window-of-opportunity' trial testing evofosfamide (TH-302), a tumour-selective hypoxia-activated cytotoxic prodrug, with preoperative chemoradiotherapy in oesophageal adenocarcinoma patients.

2016-08-1720 citations

MAESTRO: A randomized, double-blind phase III study of evofosfamide (Evo) in combination with gemcitabine (Gem) in previously untreated patients (pts) with metastatic or locally advanced unresectable pancreatic ductal adenocarcinoma (PDAC).

Journal of Clinical Oncology2016-05-2071 citations

Evofosfamide combined with gemcitabine/nab-paclitaxel in patients with previously untreated locally advanced or metastatic pancreatic adenocarcinoma (PAC): Results of a phase I trial.

Journal of Clinical Oncology2016-05-202 citations

Randomized, double-blind, placebo-controlled trial of evofosfamide (Evo) and pemetrexed (Pem) in advanced non-squamous non-small cell lung cancer (n-s NSCLC).

Journal of Clinical Oncology2016-05-20

Phase I study of evofosfamide, an investigational hypoxia‐activated prodrug, in patients with advanced leukemia

American Journal of Hematology2016-05-1238 citations

Evofosfamide (TH-302) in combination with gemcitabine in previously untreated patients with metastatic or locally advanced unresectable pancreatic ductal adenocarcinoma: Primary analysis of the randomized, double-blind phase III MAESTRO study.

Journal of Clinical Oncology2016-02-0134 citations

Abstract 2603: Combination activity of the MEK inhibitor Pimasertib and the hypoxia-activated prodrug TH-302 in pancreatic and biliary tract tumor xenograft models

Cancer Research2015-08-01

Abstract B88: Pharmacodynamic changes from the TH-302, gemcitabine, and nab-paclitaxel triplet combination in a xenograft model of pancreatic cancer

Cancer Research2015-06-30

Preliminary safety and efficacy of evofosfamide (TH-302), an investigational hypoxia-activated prodrug, combined with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma (RR MM).

Journal of Clinical Oncology2015-05-202 citations

A Phase 2 biomarker-enriched study of evofosfamide (TH-302) in patients with advanced melanoma.

Journal of Clinical Oncology2015-05-20

Efficacy and safety of the hypoxia-activated prodrug TH-302 in combination with gemcitabine and nab-paclitaxel in human tumor xenograft models of pancreatic cancer

Cancer Biology & Therapy2015-02-1351 citations

A phase I dose-escalation trial of TH-302 with nab-paclitaxel and gemcitabine in patients with locally advanced or metastatic pancreatic adenocarcinoma.

Journal of Clinical Oncology2015-01-201 citations

Randomized Phase II Trial of Gemcitabine Plus TH-302 Versus Gemcitabine in Patients With Advanced Pancreatic Cancer

Journal of Clinical Oncology2014-12-16186 citations

A Phase 1/2 Trial of TH-302 and Dexamethasone without or with Bortezomib (TBorD) in Patients with Relapsed/Refractory Multiple Myeloma

Blood2014-12-063 citations

Preliminary safety and efficacy of TH-302, an investigational hypoxia-targeted drug, and dexamethasone (dex) in patients (pts) with relapsed/refractory multiple myeloma (RR MM).

Journal of Clinical Oncology2014-05-201 citations

Phase 1 Study Of TH-302, An Investigational Hypoxia-Targeted Drug, and Dexamethasone In Patients With Relapsed/Refractory Multiple Myeloma

Blood2013-11-151 citations

Abstract B77: Phase I study of TH-302, an investigational hypoxia-targeted drug, in combination with sunitinib.

Molecular Cancer Therapeutics2013-11-013 citations

Abstract C287: Efficacy and safety of the TH-302, gemcitabine, and nab-paclitaxel combination in xenograft models of pancreatic cancer.

Molecular Cancer Therapeutics2013-11-011 citations