Table 3.
Summary of clinical trials discussed.
| Study | Study purpose | Time frame | Sample size | Outcome measures | Relevant findings | NCT# |
|---|---|---|---|---|---|---|
| Phase 1 | ||||||
| Indenoisoquinoline LMP400 for advanced solid tumors and lymphomas | Safety and efficacy of Indenoisoquinoline LMP400 for advanced solid tumors or lymphomas | February 2013–October 2017 | 21 participants | To establish the safety, tolerability, and PK profiles of weekly LMP400 in patients with refractory solid tumors and lymphomas | LMP776 is overall well tolerated | 1794104 |
| A phase I study of indenoisoquinolines LMP400 and LMP776 in adults with relapsed solid tumors and lymphomas | Study how LMP400 and LMP776 are processed by the body and how effective they are in treating difficult-to-treat types of cancer | January 2010–June 2017 | 55 participants | Define the MTD, dose-limiting toxicities, and PD endpoint (gamma-H2AX in tumor biopsy pre- and post-treatment) of LMP400 and LMP776 administered intravenously daily for 5 days | N/A | 1051635 |
| Phase-I dose finding and pharmacokinetic study of the novel hydrophilic camptothecin ST-1968 (namitecan) in patients with solid tumors | First-in-human, dose-escalation study to determine the MTD of intravenous, flat-dosed ST-1968 (namitecan), a new hydrophilic camptothecan derivative | June 2007−December 2011 | 62 participants | MTD of ST1968 given intravenously once every week for 2 consecutive weeks every 3 weeks and MTD of ST1968 given intravenously once every 3 weeks for 21 days | Neutropenia was the drug-limiting toxicity, with 15 mg being defined as the recommended dose for one group and 23 mg for the other group. Non-hematological toxicity was negligible. Namitecan exhibited fully dose-proportional PK | 1748019 |
| Phase 2 clinical trials | ||||||
| Vosaroxin and infused cytarabine in treating patients with untreated acute myeloid leukemia (VITAL) | Study how well vosaroxin and cytarabine work in treating patients with untreated acute myeloid leukemia | March 2016-Ongoing (estimated to complete in July 2019) | 61 participants | Assess the rate of complete remission after induction therapy with the vosaroxin and standard dose infused cytosine arabinoside for patients with newly diagnosed, previously untreated acute myelogenous leukemia | N/A | 2658487 |
| A phase 2 Study of CRLX101 in patients with advanced non-small cell lung cancer | Compare median overall survival of patients with advanced non-small cell lung cancer treated with CRLX101 to patients treated with best supportive care (BSC) | June 2011–October 2014 | 157 participants | Compare overall survival of patients treated with CRLX101 and BSC to patients treated with BSC only for up to 18 months | No statistical analysis provided for to compare overall survival of patients in both treatment arms | 1380769 |
| Study of AR-67 in adult patients with recurrence of glioblastoma multiforme (GBM) or gliosarcoma | Study the efficacy and determine the 6-month progression free survival (PFS) of AR-67 (7-t-butyldimethylsiltyl-10-hydroxy-camptothecin) in patients with GBM | December 2009– February 2015 | 58 participants | Determine the 6-month PFS of AR-67 administered in adults with confirmed recurrence of GBM who have not had experienced a recurrence within 90 days after receiving bevacizumab or temazolamide for treatment | N/A | 1124539 |
| Rebeccamycin analog in treating children with relapsed or refractory neuroblastoma | Study effectiveness of rebeccamycin analog in treating children diagnosed with relapsed or refractory neuroblastoma | January 1999–September 2006 | 30 participants | Determine the response rate and toxicity to rebeccamycin analogue in children with relapsed or refractory neuroblastoma | N/A | 3737 |
| Rebeccamycin analog in treating patients with metastatic or locally recurrent colorectal cancer | Study effectiveness of rebeccamycin analog in treating patients diagnosed with metastatic or locally recurrent colorectal cancer | February 2000–June 2002 | 37 participants | Determine response rate, toxicity, and overall survival of patients with metastatic or locally recurrent colorectal cancer treated with rebeccamycin analogue | N/A | 5085 |
| Rebeccamycin analogue in treating women with stage IIIB or stage IV breast cancer | Compare effectiveness of two different rebeccamycin analogue regimens in treating women diagnosed with stage IIIB or stage IV breast cancer | March 2000–May 2006 | 42 participants | Assess activity of rebeccamycin analog as therapy for advanced breast cancer administered in two different treatment regimens | N/A | 5817 |
| Intravenous edotecarin in patients with advanced gastric cancer that has progressed or recurred after chemotherapy | Study the efficacy of edotecarin in adult patients with advanced gastric cancer, reasonable performance status, good organ function, lack of serious concomitant medical conditions in repeated 3-week cycles of treatment | April 2004–June 2005 | 28 participants | Assess antitumor activity of edotecarin using repeated radiographic assessments at 6-week intervals | N/A | 87503 |
| Phase 3 | ||||||
| Comparison of pixantrone + rituximab with gemcitabine + rituximab in patients with aggressive B-cell non-Hodgkin lymphoma or follicular grade 3 lymphoma who have relapsed after therapy and are not eligible for stem cell transplant (PIX-R) | Evaluate the efficacy of Pixantrone with rituximab compared to Gemcitabine with Rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma or follicular grade 3 lymphoma | April 2011–December 2017 | 260 participants | Progression free survival from randomization to the date of disease progression or death | N/A | 1321541 |
| Gemcitabine and docetaxel versus doxorubicin as first-line treatment in previously untreated advanced unresectable or metastatic soft-tissue sarcomas (GeDDiS): a randomized controlled phase 3 trial | Compare gemcitabine and docetaxel versus doxorubicin as first-line treatment for advanced or metastatic soft-tissue sarcoma | January 2010–January 2013 | 250 participants | Progression-free survival, assessed using the RECIST Criteria every six weeks, after each set of two cycles; 2-monthly following treatment assessment | The proportion of patients alive and free of cancer progression after 24 weeks did not differ between the treatment arms. The most common adverse effects were neutropenia and febrile neutropenia in approximately the same percentage of patients who received either treatment arm. Percentage of patients who died during or after this study was also similar for both treatment arms; none of the deaths were related to the treatment. The study concludes that there is significant evidence for clinicians to consider doxorubicin as a single agent in patients with locally advanced or metastatic soft-tissue sarcoma | 07742377 inISRCTNregistry |
| Phase 3 study to treat patients with soft tissue sarcomas | Determine the efficacy and safety of aldoxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas | January 2014–May 2017 | 433 participants | Progression-free survival over 24 months | Aldoxorubicin has minimal cardiac toxicity and survival advantage in patients with leiomyosarcoma and liposarcoma | 2049905 |