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. 2014 Mar 21;105(4):370–388. doi: 10.1111/cas.12366

Table 3.

Examples of DNA damage response inhibitors in clinical trials

Pathway Target(s) Name Combination Type of cancer Clinical trial number Stage Trial periods
Cell cycle checkpoints Chk1 UCN-01 Combination therapy
Carboplatin Advanced solid tumor NCT00036777 Phase I Completed
Irinotecan Metastatic or unresectable solid tumor, triple negative breast cancer NCT00031681 Phase I Completed
Cytarabine Refractory or relapsed acute myelogenous leukemia, myelodysplastic syndrome NCT00004263 Phase I Completed
Perifosine Relapsed or refractory acute leukemia, chronic myelogenous leukemia, high risk myelodysplastic syndrome NCT00301938 Phase I Completed
Gemcitabine Unresectable or metastatic pancreatic cancer NCT00039403 Phase I Completed
Topotecan Relapsed or progressed small-cell lung cancer NCT00098956 Phase II Completed
Cisplatin Advanced malignant solid tumor NCT00012194 Phase I Terminated
Fluorouracil Metastatic pancreatic cancer NCT00045747 Phase II Completed
Prednisone Refractory solid tumor, lymphoma NCT00045500 Phase I Completed
Irinotecan Advanced solid tumor NCT00047242 Phase I Completed
Fluorouracil, leucovorin Metastatic or unresectable solid tumor NCT00042861 Phase I Completed
Topotecan Advanced ovarian epithelial, primary peritoneal, fallopian tube cancer NCT00072267 Phase II Completed
Fludarabine Recurrent or refractory lymphoma or leukemia NCT00019838 Phase I Completed
Fluorouracil Advanced or refractory solid tumor NCT00004059 Phase I Completed
Cisplatin Advanced or metastatic solid tumor NCT00006464 Phase I Completed
Topotecan Recurrent ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer NCT00045175 Phase I Completed
Fludarabine Chronic lymphocytic leukemia or lymphocytic lymphoma NCT00045513 Phase I, II Active, not recruiting
Monotherapy
Relapsed or refractory T-cell lymphoma NCT00082017 Phase II Completed
Metastatic melanoma NCT00072189 Phase II Completed
Breast cancer, lymphoma, prostatic neoplasm NCT00001444 Phase I Completed
Leukemia/lymphoma/unspecified adult solid tumor NCT00003289 Phase I Completed
Advanced or metastatic kidney cancer NCT00030888 Phase II Active, not recruiting
SCH900776 Combination therapy
Cytarabine Relapsed acute myeloid leukemia NCT01870596 Phase II Until January, 2016
Cytarabine Acute myelogenous leukemia/acute lymphocytic leukemia NCT00907517 Phase I Terminated
Gemcitabine Solid tumor/lymphoma NCT00779584 Phase I Completed
Hydroxyurea Advanced solid tumors NCT01521299 Phase I Withdrawn
LY2603618 Combination therapy
Desipramine, pemetrexed, gemcitabine Cancer NCT01358968 Phase I Completed
Pemetrexed, gemcitabine Advanced or metastatic solid tumor NCT01296568 Phase I Completed
Pemetrexed,cisplatin NSCLC NCT01139775 Phase I, II Until March, 2014
Gemcitabine Pancreatic cancer NCT00839332 Phase I, II Completed
Gemcitabine Solid tumor NCT01341457 Phase I Until December, 2014
Pemetrexed Cancer NCT00415636 Phase I Completed
Pemetrexed NSCLC NCT00988858 Phase II Until April, 2014
Chk1 and Chk2 XL844 Combination therapy
Gemcitabine Advanced cancer, lymphoma NCT00475917 Phase I Terminated
Monotherapy
Advanced cancer, lymphoma NCT00475917 Phase I Terminated
Chronic lymphocytic leukemia NCT00234481 Phase I Terminated
AZD7762 Combination therapy
Gemcitabine Solid tumor NCT00413686 Phase I Completed
Gemcitabine Solid tumor NCT00937664 Phase I Terminated
Irinotecan Solid tumor NCT00473616 Phase I Terminated
PF-00477736 Combination therapy
Gemcitabine Advanced solid tumor NCT00437203 Phase I Terminated
Non-homologous end joining DNA-PK and mTOR CC-115 Monotherapy
Multiple myeloma, non-Hodgkin's lymphoma, glioblastoma, squamous cell carcinoma of head and neck, NCT01353625 Phase I Until April, 2015
prostate cancer, Ewing's osteosarcoma, chronic lymphocytic leukemia
Base excision repair APE1 TRC102 Combination therapy
Pemetrexed Neoplasm NCT00692159 Phase I Completed
Temozolomide Lymphoma, solid tumor NCT01851369 Phase I Until February, 2015
Fludarabine Relapsed or refractory hematologic malignancy NCT01658319 Phase I Until January, 2015
Lucanthone Combination therapy
Radiotherapy Brain metastases from NSCLC NCT02014545 Phase II Until Decemcer, 2017
Temozolomide and radiation Glioblastoma multiforme NCT01587144 Phase II Terminated
PARP Rucaparib (AG014688) Combination therapy
Cisplatin Triple negative breast cancer or ER/PR+, HER2− breast cancer with known BRCA1/2 mutations NCT01074970 Phase II Until May, 2014
Carboplatin Advanced solid tumor NCT01009190 Phase I Until Dec, 2013
Monotherapy
Platinum-sensitive, relapsed, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer NCT01891344 Phase II Until December, 2015
Solid tumor (Phase I), ovarian cancer with germline BRCA mutations (Phase II) NCT01482715 Phase I, II Until March, 2014
Platinum-sensitive, high-grade serous or endometrioid epithelial ovarian, primary peritoneal or fallopian tube cancer NCT01968213 Phase III Until November, 2016
BRCA-mutated locally advanced or metastatic breast cancer or advanced ovarian cancer NCT00664781 Phase II Until September, 2014
Olaparib (AZD2281) Combination therapy
Cediranib Recurrent ovarian, fallopian tube, peritoneal cancer or recurrent triple-negative breast cancer NCT01116648 Phase I, II Until May, 2014
Abiraterone, prednisone, or prednisolone Metastatic castration-resistant prostate cancer NCT01972217 Phase II Until July, 2018
Bkm120 Recurrent triple-negative breast cancer or recurrent high-grade serous ovarian cancer NCT01623349 Phase I Until Dec, 2014
Radiotherapy Esophageal cancer NCT01460888 Phase I Until August, 2018
Paclitaxel Recurrent or metastatic gastric cancer NCT01063517 Phase II Completed
Radiotherapy with or without cisplatin Locally advanced NSCLC NCT01562210 Phase I Until March, 2015
Irinotecan, cisplatin, mitomycin C Advanced pancreatic cancer NCT01296763 Phase I, II Until January, 2016
Temozolomide Relapsed glioblastoma NCT01390571 Phase I Until September, 2015
Paclitaxel Advanced gastric cancer NCT01924533 Phase III Until December, 2017
Carboplatin and paclitaxel Stage III, stage IV relapsed ovarian cancer or uterine cancer NCT01650376 Phase I, II Until February, 2015
Radiation therapy and cetuximab Advanced squamous cell carcinoma of the head/neck with heavy smoking histories NCT01758731 Phase I Until July, 2016
Gefitinib EGFR mutation-positive advanced NSCLC NCT01513174 Phase I, II Until June, 2015
Temozolomide Advanced Ewing's sarcoma NCT01858168 Phase I Until July, 2017
Carboplatin Mixed muellerian cancer, cervical cancer, ovarian cancer, breast cancer, primary peritoneal cancer, fallopian tube cancer, NCT01237067 Phase I Until September, 2014
endometrial cancer, carcinosarcoma
Carboplatin and paclitaxel Advanced ovarian cancer NCT01081951 Phase II Until June, 2013
Cisplatin-based chemoradiotherapy Locally advanced squamous cell caricinoma of the head and neck NCT01491139 Phase I Withdrawn
Irinotecan Triple-negative metastatic breast cancer, advanced ovarian cancer NCT00535353 Phase I Until December, 2013
Carboplatin and/or paclitaxel Locally advanced or metastatic colorectal cancer NCT00516724 Phase I Until December, 2014
Dacarbazine Advanced melanoma NCT00516802 Phase I Completed
Paclitaxel Metastatic triple negative breast cancer NCT00707707 Phase I Until December, 2012
Liposomal doxorubicin Advanced solid tumor NCT00819221 Phase I Until August, 2013
Topotecan Advanced solid tumor NCT00516438 Phase I Completed
Gemcitabine Pancreatic cancer NCT00515866 Phase I Completed
Bevacizumab Advanced solid tumor NCT00710268 Phase I Completed
Cisplatin Advanced solid tumor NCT00782574 Phase I Until December, 2014
Carboplatin Breast and ovarian cancer with BRCA mutations or family histories NCT01445418 Phase I Recruiting
Monotherapy
Advanced solid tumor NCT01900028 Phase I Until February, 2015
Advanced solid tumor NCT01921140 Phase I Until March, 2015
Advanced solid tumor NCT01929603 Phase I Until May, 2015
Advanced solid tumor NCT01851265 Phase I Until July, 2014
Advanced solid tumor with normal or impaired liver function NCT01894243 Phase I Until December, 2015
Advanced solid tumor normal or impaired kidney function NCT01894256 Phase I Until December, 2015
Metastatic breast cancer with germline BRCA1/2 mutations NCT02000622 Phase III Until February, 2021
Advanced castration-resistant prostate cancer NCT01682772 Phase II Until July, 2015
Advanced solid tumor NCT01813474 Phase I Until November, 2014
BRCA-mutated ovarian cancer after a complete or partial response following platinum-based chemotherapy NCT01874353 Phase III Until June, 2020
BRCA-mutated advanced cancer NCT01078662 Phase II Until December, 2013
BRCA-mutated advanced ovarian cancer following first line platinum based chemotherapy NCT01844986 Phase III Until January, 2022
Advanced Ewing's sarcoma NCT01583543 Phase II Until April, 2015
Stage IV colorectal cancer with microsatellite instability NCT00912743 Phase II Completed
BRCA-deficient ovarian, peritoneal, fallopian tube cancer NCT01661868 Phase II Withdrawn
Advanced NSCLC NCT01788332 Phase II Until May, 2015
BRCA-positive advanced breast cancer NCT00494234 Phase II Until December, 2013
BRCA-positive advanced ovarian cancer NCT00494442 Phase II Until December, 2013
Platinum-sensitive relapsed serous ovarian cancer NCT00753545 Phase II Completed
Advanced solid tumor NCT00572364 Phase I Completed
Advanced or metastatic solid tumor NCT00633269 Phase I Completed
Ovarian cancer NCT00516373 Phase I Until December, 2014
Advanced solid tumor NCT00777582 Phase I Until March, 2014
High grade ovarian cancer, triple-negative breast cancer, BRCA-mutated breast cancer or ovarian cancer NCT00679783 Phase II Until December, 2012
BRCA-positive advanced ovarian cancer NCT00628251 Phase II Until December, 2013
Veliparib (ABT-888) Combination therapy
Gemcitabine, cisplatin Locally advanced or metastatic pancreatic cancer with BRCA or PALB2 mutations NCT01585805 Phase II Until July, 2017
Temozolomide or combination with carboplatin and paclitaxel Locally recurrent or metastatic breast cancer with BRCA mutations NCT01506609 Phase II Until May, 2015
Radiotherapy and temozolomide Newly diagnosed childhood diffuse pontine glioma NCT01514201 Phase I, II Until August, 2019
Radiotherapy Advanced solid malignancies with peritoneal carcinomatosis NCT01264432 Phase I Until April, 2014
Bendamustine, rituximab Advanced lymphoma, multiple myeloma, or solid tumors NCT01326702 Phase I, II Until November, 2015
Topotecan Relapsed epithelial ovarian, primary fallopian tube, or primary peritoneal cancer with negative or unknown BRCA status NCT01690598 Phase I, II Until April, 2015
Gemcitabine and radiotherapy Locally advanced, unresectable pancreatic cancer NCT01908478 Phase I Until July, 2019
Dinaciclib with or without carboplatin Advanced solid tumors with BRCA mutations NCT01434316 Phase I Until January, 2016
Radiotherapy, carboplatin, paclitaxel Stage III NSCLC that cannot be removed by surgery NCT01386385 Phase I, II Until December, 2016
Doxorubicin, carboplatin, bevacizumab Recurrent ovarian cancer, primary peritoneal cancer, or fallopian tube cancer NCT01459380 Phase I Until August, 2015
Cisplatin, gemcitabine Advanced biliary, pancreatic, urothelial, NSCLC NCT01282333 Phase I Terminated
Cisplatin, vinorelbine Recurrent and/or metastatic breast cancer with BRCA mutations, triple-negative breast cancer NCT01104259 Phase I Until September, 2014
Mitomycin C Metastatic, unresectable, or recurrent solid tumor NCT01017640 Phase I Until June, 2014
Capecitabine, radiotherapy Locally advanced rectal cancer NCT01589419 Phase I Until June, 2015
Cyclophosphamide Locally advanced or metastatic HER2-negative breast cancer NCT01351909 Phase I, II Until May, 2015
Docetaxel, cisplatin, fluorouracil, radiotherapy, hydroxyurea, paclitaxel Stage IV head and neck cancer Solid tumor NCT01193140 Phase II Completed
Temozolomide NCT01711541 Phase I, II Until October, 2014
Cisplatin, etoposide Extensive stage small-cell lung cancer, metastatic large cell neuroendocrine NSCLC, small-cell carcinoma of unknown primary or extrapulmonary origin NCT01642251 Phase I, II Until January, 2018
Paclitaxel, carboplatin Metastatic, unresectable solid tumor with liver or kidney dysfunction NCT01366144 Phase I Until July, 2015
Oxaliplatin, capecitabine BRCA-related malignancy, metastatic colorectal cancer, metastatic ovarian cancer, NCT01233505 Phase I Until July, 2014
metastatic gastrointestinal malignancies in which oxaliplatin has shown some activity
Carboplatin Stage III or stage IV breast cancer with BRCA mutations NCT01149083 Phase II Until June, 2014
Temozolomide Acute leukemia NCT01139970 Phase I Until October, 2013
Carboplatin, paclitaxel Solid tumor NCT01617928 Phase I Completed
Topotecan Recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, unspecified solid tumor NCT01012817 Phase I, II Until June, 2018
Carboplatin, paclitaxel Advanced NSCLC NCT01560104 Phase II Until September, 2014
Carboplatin HER2-negative metastatic or locally advanced breast cancer NCT01251874 Phase I Until September, 2013
Paclitaxel, cisplatin Advanced, persistent, or recurrent cervical cancer NCT01281852 Phase I, II Until March, 2020
Topotecan with or without carboplatin Relapsed or refractory acute leukemia, high-risk myelodysplasia, or aggressive myeloproliferative disorders NCT00588991 Phase I Until December, 2012
Abiraterone, prednisone Metastatic hormone-resistant prostate cancer NCT01576172 Phase II Until February, 2014
Topotecan and filgrastim or pegfilgrastim Persistent or recurrent cervical cancer NCT01266447 Phase II Until November, 2016
Gemcitabine Solid tumor NCT01154426 Phase I Until October, 2013
Modified FOLFOX6 Metastatic pancreatic cancer NCT01489865 Phase I, II Until December, 2014
FOLFIRI Advanced gastric cancer NCT01123876 Phase I Until December, 2014
Temozolomide Recurrent or refractory childhood central nervous system tumor NCT00946335 Phase I Until October, 2011
Temozolomide Hepatocellular carcinoma NCT01205828 Phase II Until December, 2013
Carboplatin, paclitaxel Advanced solid tumor NCT01281150 Phase I Until December, 2013
Carboplatin, paclitaxel, doxorubicin, cyclophosphamide Stage IIb-IIIc triple-negative breast cancer NCT01818063 Phase II Until April, 2018
Floxuridine Metastatic epithelial ovarian, primary peritoneal cavity, or fallopian tube cancer NCT01749397 Phase I Until March, 2016
Liposomal doxorubicin Recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer or metastatic triple-negative breast cancer NCT01145430 Phase I Until March, 2014
Bortezomib, dexamethasone Relapsed refractory multiple myeloma NCT01495351 Phase I Until October, 2013
Temozolomide Recurrent small-cell lung cancer NCT01638546 Phase II Until June, 2017
Cyclophosphamide, doxorubicin Metastatic or unresectable solid tumor, non-Hodgkin's lymphoma NCT00740805 Phase I Until December, 2013
Whole brain radiation Brain metastases from NSCLC NCT01657799 Phase II Until November, 2014
Temozolomide Recurrent high grade serous ovarian, fallopian tube, or primary peritoneal cancer NCT01113957 Phase II Completed
Temozolomide Metastatic or locally advanced breast cancer and BRCA1/2-associated breast cancer NCT01009788 Phase II Until December, 2014
Carboplatin, paclitaxel Advanced cancer with liver or kidney problems NCT01419548 Phase I Withdrawn
Whole brain radiation Cancer with brain metastases NCT00649207 Phase I Completed
Radiotherapy Inflammatory or loco-regionally recurrent breast cancer NCT01477489 Phase I Until December, 2016
Carboplatin, paclitaxel, bevacizumab Newly diagnosed ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer NCT00989651 Phase I Until July, 2014
Carboplatin, paclitaxel Advanced solid tumor or BRCA1/2-associated advanced solid tumor NCT00535119 Phase I Until October, 2012
Temozolomide Colorectal cancer NCT01051596 Phase II Until December, 2013
Cyclophosphamide Refractory BRCA-positive ovarian, primary peritoneal or ovarian high-grade serous carcinoma, fallopian tube cancer, triple-negative breast cancer, and low-grade non-Hodgkin's lymphoma NCT01306032 Phase II Until November, 2014
Irinotecan Metastatic or unresectable solid tumor, lymphoma NCT00576654 Phase I Until December, 2013
Temozolomide Recurrent or refractory childhood central nervous system tumor NCT00994071 Phase I Completed
Cyclophosphamide Refractory solid tumor or lymphoma NCT01445522 Phase I Completed
Temozolomide Recurrent high-grade glioma NCT01026493 Phase I, II Until February, 2014
Cyclophosphamide Solid tumor or lymphoma that did not respond to previous therapy NCT00810966 Phase I Active, not recruiting
Radiotherapy, temozolomide Grade IV astrocytoma NCT00770471 Phase I, II Completed
Temozolomide Metastatic prostate cancer NCT01085422 Phase I Completed
Temozolomide Advanced non-hematologic tumor NCT00526617 Phase I Completed
Topotecan Refractory solid tumor or lymphoma NCT00553189 Phase I Completed
Temozolomide Metastatic melanoma NCT00804908 Phase II Until March, 2014
Carboplatin, gemcitabine Advanced solid tumor NCT01063816 Phase I Until September, 2014
Radiotherapy Breast cancer NCT01618357 Phase I Until April, 2016
Monotherapy
Solid tumor NCT01199224 Phase I Completed
Locally advanced or metastatic pancreatic cancer NCT01585805 Phase II Until July, 2017
Metastatic, unresectable, or recurrent solid tumors NCT01017640 Phase I Until June, 2014
Stage III or Stage IV breast cancer with BRCA mutations NCT01149083 Phase II Until June, 2014
BRCA-mutated metastatic or unresectable malignancy, high grade serous ovarian, fallopian tube, or peritoneal cancer NCT01853306 Phase I Until January, 2015
BRCA-mutated epithelial ovarian, fallopian tube, or primary peritoneal cancer NCT01540565 Phase II Until April, 2014
Advanced solid tumor NCT02009631 Phase I Until December, 2014
BRCA-related malignancy, platinum-refractory ovarian, fallopian tube, or primary peritoneal cancer or basal-like breast cancer, advanced solid tumor NCT00892736 Phase I Until December, 2013
Relapsed epithelial ovarian, primary fallopian or primary peritoneal cancer with BRCA mutations NCT01472783 Phase I, II Until December, 2015
Chronic lymphocytic leukemia, follicular lymphoma, unspecified solid tumor NCT00387608 Phase I Completed
Invasive breast cancer NCT01042379 Phase II Until November, 2014
Advanced solid tumor NCT01827384 Phase II Until March, 2017
INO-1001 Combination therapy
Temozolomide Unresectable melanoma NCT00272415 Phase I Terminated
MK4827 Combination therapy
Liposomal doxorubicin Advanced solid tumor, platinum-resistant high grade serous ovarian cancer NCT01227941 Phase I Terminated
Temozolomide Advanced solid tumor, glioblastoma multiforme, melanoma NCT01294735 Phase I Completed
Carboplatin, paclitaxel, liposomal doxorubicin Advanced solid tumor NCT01110603 Phase I Terminated
Monotherapy
Advanced solid tumor NCT01226901 Phase I Terminated
Mantle cell lymphoma NCT01244009 Phase II Withdrawn
Advanced solid tumors, chronic lymphocytic leukemia, T-cell-prolymphocytic leukemia NCT00749502 Phase I Completed
Advanced HER2-negative, germline BRCA mutation-positive breast cancer NCT01905592 Phase III Until October, 2015
CEP-9722 Combination therapy
Gemcitabine, cisplatin Advanced solid tumor or mantle cell lymphoma NCT01345357 Phase I Completed
Temozolomide Advanced solid tumor NCT00920595 Phase I Completed
Monotherapy
Advanced solid tumor NCT01311713 Phase I, II Terminated
Advanced solid tumor NCT00920595 Phase I Completed
E7016 Combination therapy
Temozolomide Advanced solid tumor NCT01127178 Phase I Completed
Temozolomide Wild-type BRAF stage IV melanoma, unresectable stage III melanoma NCT01605162 Phase II Until March, 2014
BMN673 Monotherapy
Acute myeloid leukemia, myelodysplastic syndrome, chronic lymphocytic leukemia, mantle cell lymphoma NCT01399840 Phase I Until June, 2013
Advanced or recurrent solid tumor NCT01286987 Phase I Until June, 2013
Advanced solid tumor with deleterious BRCA mutations NCT01989546 Phase I, II Until August, 2016
Advanced breast cancer with BRCA mutations NCT01945775 Phase III Until June, 2016

For current status and information of clinical trials, refer to http://clinicaltrials.gov/, a service of the US National Institutes of Health. NSCLC, non-small-cell lung cancer.