Trial · NCT01127178
Study of Poly (ADP-Ribose) Polymerase (PARP) Inhibitor E7016 in Combination With Temozolomide in Subjects With Advanced Solid Tumors
NCT01127178, Phase 1, Terminated, Eisai Inc.; results first posted 2024-10-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Poly (ADP-Ribose) Polymerase (PARP) Inhibitor E7016 in Combination With Temozolomide in Subjects With Advanced Solid Tumors. Trials, record NCT01127178. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01127178
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Poly (ADP-Ribose) Polymerase (PARP) Inhibitor E7016 in Combination With Temozolomide in Subjects With Advanced Solid Tumors
- NCT number
- NCT01127178
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 12 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Solid Tumors
- Interventions
- E7016 + TMZ
- First posted
- 2010-05-20
- Last updated
- 2024-10-10
- Results first posted
- 2024-10-10
- Limitations and caveats
The study was terminated due to sponsor's strategic decision, which is unrelated to safety, therefore no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) for E7016 in Combination With Temozolomide | Cycle 1 (Cycle length = 28 days) | The MTD was defined as the highest dose of E7016 in combination with temozolomide at which no more than one of six participants experienced a dose-limiting toxicity (DLT). DLTs were defined as those adverse events (AEs) considered related to E7016 which occurred during the first cycle of study drug administration. DLTs were evaluated and graded based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version \[v\] 4.0). |
| Primary | Number of Participants With Dose-limiting Toxicity (DLT) | Cycle 1 (Cycle length = 28 days) | A DLT was defined as those AEs considered related to E7016 which occurred during the first cycle of study drug administration. DLTs were evaluated and graded based on the NCI CTCAE version 4.0. The following toxicities were regarded as DLTs: a Grade 4 hematologic toxicity (lasting \[greater than or equal to\] \>=5 days); a temozolomide dose reduction for Grade \>=3 neutropenia or thrombocytopenia; or a Grade \>=3 nonhematologic toxicity (except optimally managed nausea, vomiting, or diarrhea) that was assessed by the investigator as related to study drug. A participant with two or more DLTs with the same preferred term was counted only once for that preferred term. |
| Primary | Alternative Dose of Interest (ADI) for E7016 in Combination With Temozolomide | Cycle 1 (Cycle length = 28 days) | The ADI determination plan was based primarily on clinical, and/or PK measurements of drug concentration and/or bioactivity as defined by preclinical studies. However, the ADI was not pursued due to the limited sample size. |
| Secondary | Objective Response Rate (ORR) | From Cycle 1 Day 1 up to 6 Cycles (Cycle length=28 days) of treatment, an average of 24 weeks | The ORR was defined as the percentage of participants with complete response (CR) plus partial response (PR) as determined by the investigator, using modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in the evaluation of magnetic resonance imaging/computerized tomography (MRI/CT) scans of targeted lesions and photographs and bone scans if appropriate for the tumor type. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions. ORR = CR + PR |
| Secondary | Disease Control Rate (DCR) | From Cycle 1 Day 1 up to 6 Cycles (Cycle length=28 days) of treatment, an average of 24 weeks | DCR was defined as the percentage of participants who had BOR of CR plus PR plus stable disease (SD). The best observed response (BOR) was defined as the best response recorded from the start of the study treatment until discontinuation from the study. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions. SD was defined as nonCR/non-progressive disease (PD) (NN), for participants with nontarget lesions. The minimum duration of SD was 7 weeks of multiple dose treatment. For participants who did not have target lesions, the response category NN was used instead of SD. DCR = CR + PR + SD greater than or equal to 7 weeks |
| Secondary | Overall Survival (OS) | From Cycle 1 Day 1 up to 6 Cycles (Cycle length=28 days) of treatment, an average of 24 weeks | OS was defined as the time from the first dose of E7016 until 6 Cycles of treatment or death whichever occurs first. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) for E7016 in Combination With Temozolomide | Cycle 1 (Cycle length = 28 days) | The SAS consisted of all participants who received at least one dose of E7016 or temozolomide and had at least one safety assessment after receiving these medications. | mg/kg/day | NUMBER |
| PRIMARY | Number of Participants With Dose-limiting Toxicity (DLT) | Cycle 1 (Cycle length = 28 days) | The SAS consisted of all participants who received at least one dose of E7016 or temozolomide and had at least one safety assessment after receiving these medications. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Alternative Dose of Interest (ADI) for E7016 in Combination With Temozolomide | Cycle 1 (Cycle length = 28 days) | An ADI was not pursued due to the limited sample size. No data was collected and analyzed to report in this outcome measure. | ||
| SECONDARY | Objective Response Rate (ORR) | From Cycle 1 Day 1 up to 6 Cycles (Cycle length=28 days) of treatment, an average of 24 weeks | The SAS consisted of all participants who received at least one dose of E7016 or temozolomide and had at least one safety assessment after receiving these medications. | Percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) | From Cycle 1 Day 1 up to 6 Cycles (Cycle length=28 days) of treatment, an average of 24 weeks | The SAS consisted of all participants who received at least one dose of E7016 or temozolomide and had at least one safety assessment after receiving these medications. | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | From Cycle 1 Day 1 up to 6 Cycles (Cycle length=28 days) of treatment, an average of 24 weeks | The SAS consisted of all participants who received at least one dose of E7016 or temozolomide and had at least one safety assessment after receiving these medications. | days | MEDIAN |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) for E7016 in Combination With Temozolomide | Dose Escalation Part, All Participants: E7016 + Temozolomide | 4 | mg/kg/day | ||
| Number of Participants With Dose-limiting Toxicity (DLT) | Dose Escalation Part: E7016 4 mg/kg/Day + Temozolomide 150 mg/m^2 | Tachycardia | 0 | Participants | |
| Number of Participants With Dose-limiting Toxicity (DLT) | Dose Escalation Part: E7016 8 mg/kg/Day + Temozolomide 150 mg/m^2 | Tachycardia | 2 | Participants | |
| Number of Participants With Dose-limiting Toxicity (DLT) | Dose Escalation Part: E7016 4 mg/kg/Day + Temozolomide 150 mg/m^2 | Presyncope | 0 | Participants | |
| Number of Participants With Dose-limiting Toxicity (DLT) | Dose Escalation Part: E7016 8 mg/kg/Day + Temozolomide 150 mg/m^2 | Presyncope | 2 | Participants | |
| Number of Participants With Dose-limiting Toxicity (DLT) | Dose Escalation Part: E7016 4 mg/kg/Day + Temozolomide 150 mg/m^2 | Hypotension | 0 | Participants | |
| Number of Participants With Dose-limiting Toxicity (DLT) | Dose Escalation Part: E7016 8 mg/kg/Day + Temozolomide 150 mg/m^2 | Hypotension | 1 | Participants | |
| Objective Response Rate (ORR) | Dose Escalation Part: E7016 4 mg/kg/Day + Temozolomide 150 mg/m^2 | 0.0 | Percentage of participants | ||
| Objective Response Rate (ORR) | Dose Escalation Part: E7016 8 mg/kg/Day + Temozolomide 150 mg/m^2 | 0.0 | Percentage of participants | ||
| Disease Control Rate (DCR) | Dose Escalation Part: E7016 4 mg/kg/Day + Temozolomide 150 mg/m^2 | 11.1 | Percentage of participants |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Escalation: Treatment Phase | STARTED | Dose Escalation Part: E7016 4 mg/kg/Day + Temozolomide 150 mg/m^2 | 9 | |
| Dose Escalation: Treatment Phase | STARTED | Dose Escalation Part: E7016 8 mg/kg/Day + Temozolomide 150 mg/m^2 | 3 | |
| Dose Escalation: Treatment Phase | COMPLETED | Dose Escalation Part: E7016 4 mg/kg/Day + Temozolomide 150 mg/m^2 | 5 | |
| Dose Escalation: Treatment Phase | COMPLETED | Dose Escalation Part: E7016 8 mg/kg/Day + Temozolomide 150 mg/m^2 | 3 | |
| Dose Escalation: Treatment Phase | NOT COMPLETED | Dose Escalation Part: E7016 4 mg/kg/Day + Temozolomide 150 mg/m^2 | 4 | |
| Dose Escalation: Treatment Phase | NOT COMPLETED | Dose Escalation Part: E7016 8 mg/kg/Day + Temozolomide 150 mg/m^2 | 0 | |
| Dose Escalation: Extension Phase | STARTED | Dose Escalation Part: E7016 4 mg/kg/Day + Temozolomide 150 mg/m^2 | 5 | |
| Dose Escalation: Extension Phase | STARTED | Dose Escalation Part: E7016 8 mg/kg/Day + Temozolomide 150 mg/m^2 | 3 | |
| Dose Escalation: Extension Phase | COMPLETED | Dose Escalation Part: E7016 4 mg/kg/Day + Temozolomide 150 mg/m^2 | 3 | |
| Dose Escalation: Extension Phase | COMPLETED | Dose Escalation Part: E7016 8 mg/kg/Day + Temozolomide 150 mg/m^2 | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events160
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Dose Escalation Part: E7016 4 mg/kg/Day + Temozolomide 150 mg/m^2 | 2 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | Dose Escalation Part: E7016 8 mg/kg/Day + Temozolomide 150 mg/m^2 | 1 | 3 | |
| other | Palpitations | Cardiac disorders | Dose Escalation Part: E7016 4 mg/kg/Day + Temozolomide 150 mg/m^2 | 1 | 9 | |
| other | Palpitations | Cardiac disorders | Dose Escalation Part: E7016 8 mg/kg/Day + Temozolomide 150 mg/m^2 | 0 | 3 | |
| other | Tachycardia | Cardiac disorders | Dose Escalation Part: E7016 4 mg/kg/Day + Temozolomide 150 mg/m^2 | 1 | 9 | |
| other | Tachycardia | Cardiac disorders | Dose Escalation Part: E7016 8 mg/kg/Day + Temozolomide 150 mg/m^2 | 3 | 3 | |
| other | Periorbital oedema | Eye disorders | Dose Escalation Part: E7016 4 mg/kg/Day + Temozolomide 150 mg/m^2 | 1 | 9 | |
| other | Periorbital oedema | Eye disorders | Dose Escalation Part: E7016 8 mg/kg/Day + Temozolomide 150 mg/m^2 | 0 | 3 | |
| other | Vision blurred | Eye disorders | Dose Escalation Part: E7016 4 mg/kg/Day + Temozolomide 150 mg/m^2 | 1 | 9 | |
| other | Vision blurred | Eye disorders | Dose Escalation Part: E7016 8 mg/kg/Day + Temozolomide 150 mg/m^2 | 0 | 3 |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Escalation Part: E7016 4 mg/kg/Day + Temozolomide 150 mg/m^2 | 4 | 9 |
| Total, all-cause mortality | Dose Escalation Part: E7016 8 mg/kg/Day + Temozolomide 150 mg/m^2 | 0 | 3 |
| Total, other adverse events | Dose Escalation Part: E7016 4 mg/kg/Day + Temozolomide 150 mg/m^2 | 9 | 9 |
| Total, other adverse events | Dose Escalation Part: E7016 8 mg/kg/Day + Temozolomide 150 mg/m^2 | 3 | 3 |
| Total, serious adverse events | Dose Escalation Part: E7016 4 mg/kg/Day + Temozolomide 150 mg/m^2 | 5 | 9 |
| Total, serious adverse events | Dose Escalation Part: E7016 8 mg/kg/Day + Temozolomide 150 mg/m^2 | 1 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dose Escalation Part: E7016 4 mg/kg/Day + Temozolomide 150 mg/m^2 vs Dose Escalation Part: E7016 8 mg/kg/Day + Temozolomide 150 mg/m^2: deaths from any cause | Trial comparisons |
| Dose Escalation Part: E7016 4 mg/kg/Day + Temozolomide 150 mg/m^2 vs Dose Escalation Part: E7016 8 mg/kg/Day + Temozolomide 150 mg/m^2: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01127178
GET https://conductscience.org/api/trials/v1/NCT01127178/events?page=2