A phase II study of combination CPT-11 and docetaxel in patients with ovarian carcinoma refractory or resistant to combination paclitaxel and carboplatin

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 15036-15036
Author(s):  
T. Enomoto ◽  
K. Yoshino ◽  
M. Yamasaki ◽  
Y. Nishio ◽  
A. Wakimoto ◽  
...  
Keyword(s):  
Ovarian Carcinoma ◽  
Combination Chemotherapy ◽  
Response Rate ◽  
Phase Ii Study ◽  
First Line ◽  
Good Compliance ◽  
Measurable Disease ◽  
Grade 3 ◽  
Line Chemotherapy ◽  
Carboplatin Auc

15036 Background: To investigate the efficacy and toxicity of combination irinotecan and docetaxel in patients with ovarian carcinoma refractory (not responded) or resistant (relapsed within 6 months after the last chemotherapy) to the first line chemotherapy with combination paclitaxel (175mg/m2) and carboplatin (AUC=5). Methods: 30 refractory patients and 28 resistant patients with measurable disease were treated with combination irinotecan (60 mg/m2) and docetaxel (30 mg/m2) at days 1 and 8 every 3 weeks for more than 2 courses. Results: The average number of courses administered was 2.6 for refractory cases and 3.4 for resistant cases. The average number of courses administered was 2.6 for refractory cases and 3.4 for resistant cases. Using RECIST criteria, 2/28 (7%) resistant cases responded completely, 6/30 (20%) of refractory cases and 6/28 (21%) resistant cases were responded partially. 16/30 refractory cases and 14/28 cases progressed. Grade 3–4 toxicities were leukopenia (31%) neutropenia (36%) thrombocytopenia (8%) and diarrhea (6%). Conclusions: Combination chemotherapy of CPT-11 and Docetaxel at days 1 and 8 every 3 weeks is a regimen with moderate toxicity and good compliance, and shows some response to those patients who are refractory or resistant to the first-line chemotherapy with paclitaxel and carboplatin with a response rate of 20% and 29%, respectively. No significant financial relationships to disclose.

A phase II study of irinotecan, oxaliplatin, 5-fluorouracil, leucovorin (FOLFOXIRI) as a first-line chemotherapy in metastatic gastric cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4076-4076
Author(s):  
J. Lee ◽  
W. Kang ◽  
S. Lee ◽  
J. Kwon ◽  
H. Kim ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Phase Ii ◽  
Combination Chemotherapy ◽  
Response Rate ◽  
Phase Ii Study ◽  
Objective Response ◽  
Metastatic Gastric Cancer ◽  
Efficacy And Safety ◽  
First Line ◽  
Grade 3

4076 Background: Previous phase II study showed a high efficacy and safety of FOLFOXIRI (irinotecan, oxaliplatin, 5-fluorouracil, leucovorin) combination chemotherapy in metastatic colorectal cancer. This non-randomized open label phase II study evaluated the efficacy and safety of FOLFOXIRI in metastatic or recurrent gastric cancer patients. Methods: Patients with: histologically proven, bidimensionally measurable, metastatic gastric adenocarcinoma, age 18 - 70 years, with a performance status 0 - 2, no prior chemotherapy or at least 12 months after adjuvant therapy, life expectancy > 3 months, signed written informed consent were eligible. Treatment consisted of irinotecan 150 mg/m2 day 1, oxaliplatin 85 mg/m2 day 1, leucovorin 100 mg/m2 day and 5-fluorouracil 2000 mg/m2 as a 48-h continuous infusion starting on day 1, repeated every 2 weeks until unacceptable toxicity, patients’ refusal, or up to 12 cycles. The planned sample size was 48 and the primary endpoint was response rate. Results: From August 2004 to August 2005, 48 patients were prospectively enrolled. The median age was 54 years (24 - 69) and male:female ratio was 1.3:1. In total, 379 cycles were administered with a median of 9 cycles per patient (range, 1–12) and 45/48 patients were evaluable for treatment response. Three patients were not assessable for response due patients’ refusal for further chemotherapy following the first cycle. By per-protocol analysis, the objective response rate was 73.3 % (95% CI, 60.8–85.8) with 2 CRs and 31 PRs. Four patients (9%) had stable disease and 8 patients (18%) had progressive disease. The estimated median survival of all patients was 14.0 months (95% CI, 11.8 - 16.2 ) and the estimated median time-to-progression was 8.9 months (95% CI, 6.7–11.0). In total of 379 cycles administered, most common grade 3/4 toxicities were neutropenia (11% of all cycles) and emesis (12%). Grade 2 peripheral neuropathy occurred in 5 patients. One (2%) patient had severe tumor bleeding and 5 (10%) patients experienced grade 3 diarrhea. Conclusions: FOLFOXIRI combination chemotherapy showed a very promising preliminary anti-tumor activity and was generally well tolerated as a first-line treatment for patients with metastatic gastric cancer. No significant financial relationships to disclose.

scholarly journals A Phase II Study of Docetaxel and Epirubicin in Advanced Adult Soft Tissue Sarcomas (STS)

Sarcoma ◽  
2004 ◽  
Vol 8 (4) ◽  
pp. 129-133 ◽  
Author(s):  
Haralabos P. Kalofonos ◽  
Charalabos Kourousis ◽  
Michalis V. Karamouzis ◽  
Gregoris Iconomou ◽  
Ekaterini Tsiata ◽  
...  
Keyword(s):  
Response Rate ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Soft Tissue Sarcomas ◽  
Complete Response ◽  
Efficacy And Safety ◽  
First Line ◽  
Grade 3 ◽  
Epirubicin Combination ◽  
Line Chemotherapy

Purpose:The aim of this study was to determine the efficacy and safety of docetaxel plus epirubicin combination as first-line chemotherapy in patients with locally advanced and/or metastatic adult STS.Patients and Methods:Eighteen patients were treated with epirubicin 30 mg/m2on days 1 to 3 and docetaxel 100 mg/m2on day 1 every 3 weeks.Results:Fifteen out of 18 patients (83.4%) were assessable for response. No complete response was recorded. Three (20%) patients achieved PR, 3 had SD and 9 PD. The overall median survival was 14 months (range, 3–48 months) and the median time to disease progression was 4 months (range, 2–45 months). Grade ≥ 3 neutropenia occurred in 88% and neutropenic fever in 27.8% of patients. Other toxicities were mild. No treatment related deaths occurred.Discussion:Docetaxel plus epirubicin combination achieved low response rate with severe myelotoxicity in patients with advanced STS.

Paclitaxel, cisplatin, and cyclophosphamide (PCC) first-line chemotherapy for advanced ovarian carcinoma: Long-term results of a phase II study

2004 ◽  
Vol 22 (14_suppl) ◽  
pp. 5135-5135
Author(s):  
A. García-Velasco ◽  
S. Hernando ◽  
C. Mendiola ◽  
D. Castellano ◽  
A. Sánchez-Muñoz ◽  
...  
Keyword(s):  
Ovarian Carcinoma ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Long Term Results ◽  
First Line ◽  
Advanced Ovarian Carcinoma ◽  
Line Chemotherapy

Pemetrexed (MTA) and carboplatin (CBDCA) in the treatment of advanced pleural mesothelioma (MPM)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7093-7093 ◽  
Author(s):  
B. Castagneto ◽  
M. Mencoboni ◽  
D. Degiovanni ◽  
A. Muzio ◽  
L. Giaretto ◽  
...  
Keyword(s):  
Overall Response Rate ◽  
Response Rate ◽  
Phase Ii Study ◽  
Performance Status ◽  
Entire Group ◽  
Hematologic Toxicity ◽  
First Line ◽  
Ecog Performance Status ◽  
Grade 3

7093 Background: Aim of this study was to evaluate the activity and toxicity of MTA and CBDCA combination as first line chemotherapy in advanced MPM. Methods: Chemonaive patients (pts) with histologically proven, an ECOG performance status (PS) 0–2, and measurable advanced MPM were considered. The schedule of administration was: pemetrexed 500 mg/m2 in combination with CBDA AUC 5, once every 21 days for 8 cycles. Results: From July 2003 to March 2005 76 pts (54 male and 22 female) have been treated with this combination chemotherapy. Median age was 62.7 years (range 40–70); median PS 0 (range 0–3); epithelial histologic findings were in 57 (75%), mixed in 13 (17.1%), sarcomatous in 3 (3.9%), and unspecified in 3 (3.9%) pts. A total of 537 cycles was administered (median 7, range 1 to 13). Grade 3 hematologic toxicity according to WHO criteria was seen in 43 (56.6%) pts (neutropenia in 30, thrombocytopenia in 8, and anemia in 5); grade 4 hematologic toxicity in 5 (6.6%) pts. The most common nonhematologic events were grade 3 nausea/vomiting in 10 (13.1%), and fever in 4 (5.3%) pts. 74 pts were evaluable for clinical response. There were 16 (21.%) partial responses (PR) and 3 (3.9%) complete responses (CR), for an overall response rate of 23.9%. 29 (38.2%) pts reported stable disease (SD). The overall survival was considered from date of diagnosis to date of death from any cause or to date of last follow-up. The median survival time for the entire group was estimated at 23 months. Conclusions: The results of this phase II study indicate that, at this dose and schedule, the combination of CBDCA and MTA is moderately active and that the profile of toxicity is acceptable in pts with advanced MPM. No significant financial relationships to disclose.

Multi-institutional phase II study of carboplatin-gemcitabine combination chemotherapy in elderly patients (pts) with advanced non-small cell lung cancer (NSCLC)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 18179-18179
Author(s):  
J. Sasaki ◽  
H. Uramoto ◽  
K. Kashiwabara ◽  
H. Kishi ◽  
E. Moriyam ◽  
...  
Keyword(s):  
Phase Ii ◽  
Combination Chemotherapy ◽  
Advanced Nsclc ◽  
Response Rate ◽  
Group Performance ◽  
Phase Ii Study ◽  
Single Agent ◽  
Objective Response ◽  
Efficacy And Safety ◽  
Grade 3

18179 Background: Because elderly pts may tolerate platinum-based combination chemotherapy poorly, single-agent chemotherapy is selected for the treatment regimen. However, retrospective subgroup analyses have consistently indicated that elderly pts indeed benefit from platinum-based combination chemotherapy as well as their younger counterparts. This phase II study evaluated the efficacy and safety of carboplatin-gemcitabine combination chemotherapy in elderly pts with advanced NSCLC. Methods: Fifty-four pts aged more than 70 years old (median, 77; range, 70–88) with previously untreated advanced NSCLC were enrolled on this trial. Additional criteria included the presence of measurable lesions, an Eastern Cooperative Oncology Group performance status of 0 or 1, and adequate organ function. Pts received carboplatin at an area under the curve of 4 mg/ml/min on the first day and gemcitabine at 1000 mg/m2 on the first and eighth day of consecutive 3 week periods. The primary endpoint was to determine the objective response rate of this platinum-doublet regimen. The RECIST criteria were used to measure response. Results: Enrolled pts included 15/39 with stage IIIB/IV diseases. Fifty-one out of enrolled pts were eligible for efficacy and safety analyses. The median number of treatment cycles was 4 (range, 1–7). Fifteen partial responses (response rate: 29%) were obtained. The median TTP was 118 days. Hematological toxicities of grade 3/4 included leukopenia (46%), neutropenia (72%) and thrombocytopenia (50%). Non-hematological toxicities of grade 3/4 included nausea (6%), appetite loss (7%), fatigue (7%) and infection (9%). Conclusions: The combination carboplatin-gemcitabine at these doses has shown activity with a favorable toxicity profile for fit elderly pts with advanced NSCLC. No significant financial relationships to disclose.

Concomitant chemoradiotherapy phase II study comparing pemetrexed/carboplatin with paclitaxel/carboplatin in patients with unresectable stage III non-small cell lung cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e17527-e17527
Author(s):  
Shenglin Ma ◽  
Yaping Xu ◽  
Yongling Ji ◽  
Xiaojiang Sun ◽  
Yuanda Zheng
Keyword(s):  
Lung Cancer ◽  
Response Rate ◽  
Phase Ii Study ◽  
Small Cell ◽  
Stage Iii ◽  
Small Cell Lung ◽  
Concomitant Chemoradiotherapy ◽  
Unresectable Stage ◽  
Grade 3 ◽  
Carboplatin Auc

e17527 Background: Concomitant chemoradiotherapy is the standard treatment of unresectable stage III non-small cell lung cancer (NSCLC). However, the optimal chemotherapy regimen is still controversial. We have conducted a phase II study to evaluate concomitant treatment using pemetrexed/carboplatin or paclitaxel/carboplatin in these patients. The purpose of this study is to compare the feasibility and activity, and also assess its impact on progression-free survival (PFS). Methods: A total of 37 patients were enrolled between January 2008 and May 2011. Patients received concomitant chemoradiotherapy [thoracic radiotherapy and pemetrexed 500mg/m2, carboplatin AUC 5 every 3 weeks for 2 cycles; or paclitaxel 50mg/m2, carboplatin AUC 2 weekly for 6 weeks. ] Objective response rate according to the RECIST criteria was recorded and toxicity was evaluated using the NCI Common Toxicity Criteria. The Kaplan–Meier method was used to evaluate patient survival. Univariate analysis of patient characteristics and tumor responses was conducted using the Chi-square and Fisher's exact test. Results: The overall response rate for pemetrexed/carboplatin was statistically superior to paclitaxel/carboplatin (P <0.05). In patients with adenocarcinoma, there was a significant improvement in PFS with pemetrexed/carboplatin versus paclitaxel/carboplatin (11.6 vs. 9.3 months, respectively). For pemetrexed/carboplatin, rates of grade 3 or 4 neutropenia, anemia, thrombocytopenia, and febrile neutropenia were significantly lower (P <0.05), whereas grade 3 or 4 fatigue (P = 0.08) was more common. Conclusions: This data suggests that concomitant chemoradiotherapy with pemetrexed/carboplatin was better tolerability and more efficacy than paclitaxel/carboplatin in a Chinese population with unresectable stage III NSCLC. Better outcomes were observed in patients with adenocarcinoma in pemetrexed/carboplatin. Although the data presented herewith appears more promising in pemetrexed/carboplatin, this study is relatively small, and more data from randomized trials are needed to further validate this regimen.

Carboplatin-based sequential chemotherapy for aged patients with advanced bladder cancer.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 342-342
Author(s):  
Takahiro Yoneyama ◽  
Yuki Tobisawa ◽  
Tohru Yoneyama ◽  
Hayato Yamamoto ◽  
Atsushi Imai ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Response Rate ◽  
Response Duration ◽  
First Line ◽  
Sequential Chemotherapy ◽  
Aged Patients ◽  
Limited Effectiveness ◽  
Advanced Bladder Cancer ◽  
Grade 3 ◽  
Carboplatin Auc

342 Background: We retrospectively evaluated the feasibility and effectiveness of carboplatin based chemotherapy for the patients 65 years or older with advanced bladder cancer. Methods: We treated 86 patients with advanced bladder cancer at our clinic between August 2004 and June 2014. 56 patients (40 men and 16 women) with the age of 65 years or older were enrolled. Their average age was 75.8 years old (65–86), average Ccr was 54.4 ml/min (14.5–113.0), and an average follow-up period was 21.7 months (2–81). There were 18 recurrent cases after radical surgery and 38 inoperable cases. The therapeutic regimen consisted of 2 lines: gemcitabine/carboplatin (GCarbo) therapy as the first line, with two courses as a set; GCarbo/docetaxel (GCarboD) therapy as the second line if the response in the first line was insufficient. GCarbo consisted of 800mg/m2 gemcitabine on days 1, 8, and 15 and carboplatin (AUC 4) on day 2. If this regimen was effective, another 2 courses of GCarbo was performed. If this regimen did not induce any tumor size reduction, we switched to GCarboD, which consisted of 800mg/m2 gemcitabine on days 1 and 8, 70mg/m2 docetaxel on day 1, and carboplatin(AUC 3) on day 2. Treatment efficacy was checked every 2 course. Results: Of the 56 subjects who had undergone the GCarbo therapy, the response rate was 37.5% (CR+PR) with 4 and 17 subjects exhibiting CR and a PR, respectively; the average response duration was 10.0 months (2–78). The response rates of 12 instances of GCardoD was25.0 %; the overall median survival was 14.0 months throughout the carboplatin-based sequential chemotherapy. Adverse events (AE) of grade 3 or higher occurred in 33 of those who had undergone the GCarbo therapy (58.9%). In GCarboD regimen, there were 11 (91.7 %) of G3/4 AEs. Conclusions: Although the present study is small and preliminary, the present carboplatin-based sequential chemotherapy is safe and active for advanced bladder cancer of the patients 65 years or older. GCarbo regimen achieved acceptable response rate (37.5%) in advanced bladder cancer. The median overall survival of 14.0 months is acceptable when average age of 75.8 year for the subjects is took into consideration. However, GCardoD had limited effectiveness for non-responder of GCarbo.

Cetuximab plus docetaxel-cisplatin (DC) as first-line treatment for locally advanced or metastatic gastric cancer: Preliminary results of a phase II study

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15592-e15592
Author(s):  
J. Fahlke ◽  
K. Ridwelski ◽  
A. Florschuetz ◽  
E. Kettner ◽  
M. Leithaeuser ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Disease Progression ◽  
Phase Ii ◽  
Overall Response Rate ◽  
Response Rate ◽  
Phase Ii Study ◽  
Published Data ◽  
First Line ◽  
Overall Response ◽  
Grade 3

e15592 Background: Based on promising published data, this multicenter, phase II study was initiated to investigate a combined treatment using DC and cetuximab in the first-line setting for patients with gastric cancer. Methods: Patients aged 18–75 years with stage III (T4, nonresectable) or stage IV gastric cancer, ECOG performance status (PS) ≤2, and life expectancy ≥3 months were recruited to receive cetuximab (400 mg/m2 on day 1 then 250 mg/m2 q1w) and DC (D 75 mg/m2 and C 75 mg/m2; both as 1-h infusions on day 1 and then q3w). Treatment was stopped in the event of disease progression, intolerable toxicity, or consent withdrawal. Tumor staging was performed after cycle 3 and then every 12 weeks. The primary endpoint was overall response rate and secondary endpoints included time to progression, overall survival and toxicity. Planned accrual was 79 patients. A per-protocol interim response analysis was planned for the initial 20 evaluable patients. Results: Preliminary data are available for 30 patients; median age 64 [range: 40–73] years; median ECOG PS 1 [range: 0–2]; adenocarcinoma 87%. Median cycles administered were 3 [range: 1–14] and the median follow-up was 1.63 months. The overall response rate was 27.3% (complete response, n=1; partial response, n=5). Stable disease was observed in 10 patients, and disease progression in 6 patients. The most relevant NCI-CTC grade 3–4 hematologic events per patient were leukopenia and neutropenia (73%), anemia (13%), and febrile neutropenia (10%). Major grade 3–4 nonhematologic toxicities were nausea (30%), vomiting (20%), diarrhea (13%), acne (13%), and fatigue (13%). Conclusions: DC and cetuximab were well tolerated and resulted in promising response rates and a predictable toxicity profile. The study is ongoing. No significant financial relationships to disclose.

Multicenter phase II study of FOLFOX or biweekly XELOX and cetuximab as first-line treatment in patients with wild-type KRAS/BRAF metastatic colorectal cancer (mCRC) (FLEET study).

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 463-463
Author(s):  
Ho Min Kim ◽  
Hitoshi Soda ◽  
Shoichi Hazama ◽  
Takao Takahashi ◽  
Naoki Nagata ◽  
...  
Keyword(s):  
Phase Ii ◽  
Response Rate ◽  
Phase Ii Study ◽  
Predictive Biomarker ◽  
Wild Type ◽  
First Line ◽  
First Line Therapy ◽  
Multicenter Phase ◽  
Grade 3 ◽  
Few Data

463 Background: Cetuximab and chemotherapy as first-line therapy for patients with KRAS wild type prolong survival. However, COIN trial has not demonstrated the survival benefit of FOLFOX or XELOX and cetuximab therapy. Few data are available on its benefit for patients with KRAS and BRAF wild-type. Methods: The aim of this study was to assess the efficacy of first-line FOLFOX or bi-weekly XELOX and bi-weekly cetuximab in KRAS/BRAF wt mCRC. Chemonaive patients received FOLFOX or biweekly XELOX (oxaliplatin 85 mg/ m2/day 1 plus capecitabine 2000/m2/days 1-7) and biweekly cetuximab 500mg m2/ day 1 every 2 weeks. Primary endpoint was response rate(RR), other secondary endpoints were PFS, OS, DCR, safety, DI and resection rate. KRAS test (codon12,13) and BRAF test (V600E) by direct sequence were performed in Yamaguchi University. Patients with KRAS/BRAF wt were enrolled in this study. The regimen of FOLFOX or XELOX were selected by investigator’s preference, not randomized. Results: From April 2010 to May 2011, 139 pts were preregistered. KRAS and BRAF were examined from paraffin-embedded sample. 70 (50.3%) pts were KRAS/BRAF wt, and 62 pts were enrolled: The main characteristics of the entered pts were: sex (M/F) 34/28, median age 66 yrs (range 34-83 yrs). Grade 3/4 adverse events were leucopenia 4.8%, neutropenia 25.8%, skin toxity (paronychia/fissure) 9.7%, and acne 9.7%. Two CR (3.2%) and 40 PR (64.5%), 15 SD (24.2%) and 3 PD (4.8%) 2NE were observed, with an overall response rate of 67.7% and a disease control rate (CR+PR+SD) of 91.9%. The RR of FOLFOX or XELOX were 64.9% (24/37) and 72.0% (18/25), DCR were 89.2% and 96% respectively. Conclusions: FLEET was the first multicenter phase II study with prospective KRAS/BRAF analysis as a predictive biomarker for cetuximab in first-line mCRC in Japan. Results of this study indicate that both biweekly combination regimens are feasible, tolerable, and clinically active. Biweekly XELOX+cetuximab study (FLEET2) is ongoing. Clinical trial information: UMIN000003253.

scholarly journals Phase II study of DHP107 (oral paclitaxel) in the first-line treatment of HER2-negative recurrent or metastatic breast cancer (OPTIMAL study)

2021 ◽  
Vol 13 ◽  
pp. 175883592110619
Author(s):  
Sung-Bae Kim ◽  
Jae Hong Seo ◽  
Jin-Hee Ahn ◽  
Tae-Yong Kim ◽  
Seok Yun Kang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Phase Ii ◽  
Triple Negative ◽  
Response Rate ◽  
Phase Ii Study ◽  
Objective Response ◽  
Line Treatment ◽  
First Line ◽  
Grade 3 ◽  
First Line Treatment

Background: Standard intravenous (IV) paclitaxel is associated with hypersensitivity/toxicity. Alternative IV formulations have improved tolerability but still require frequent hospital visits and IV infusion. DHP107 is a novel oral formulation of paclitaxel that is approved in South Korea for the treatment of gastric cancer. Methods: This multicenter, phase II study using a Simon’s two-stage design investigated the efficacy and safety of DHP107 200 mg/m2 administered orally twice daily on days 1, 8, and 15 every 4 weeks for the first-line treatment of recurrent or metastatic HER2-negative breast cancer. Results: Thirty-six patients were enrolled and 31 were assessable for efficacy. Patient median age was 57 years (range = 34–81) and 11 (31%) had triple-negative disease. A median of seven cycles (range = 1–28) of DHP107 was administered. Objective response rate was 55% (17 patients), all partial responses, according to the investigator’s decision and independent central review (ICR), and 44% (4/9 patients) in those with triple-negative disease. Disease control rate (partial response and stable disease) was 74% (23 patients) according to the investigator’s decision and ICR. In the intention-to-treat (ITT) population of all enrolled participants, the objective response rate was 50% (18/36 patients). Median progression-free survival was 8.9 months [95% confidence interval [CI]: 5.2–12.3) and median time to treatment failure was 8.0 months (95% CI: 4.2–10.0). DHP107 had an acceptable toxicity profile. All patients experienced treatment-emergent adverse events; the most common adverse events were decreased neutrophil count (81% all grades and 78% grade ⩾ 3) followed by peripheral sensory neuropathy (61% all grades and 8% grade 3). However, there was no febrile neutropenia or sepsis. Conclusion: DHP107 showed promising efficacy and acceptable tolerability in this phase II study and is currently being investigated in the OPTIMAL phase III study (NCT03315364). Trial registration: This trial was registered with ClinicalTrials.gov identifier: NCT03315364.

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