Trial · NCT01011439
Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma
NCT01011439, Phase 2, Terminated, Tiziana Life Sciences LTD; results first posted 2018-10-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma. Trials, record NCT01011439. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01011439
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma
- NCT number
- NCT01011439
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 72 participants, actual
- Lead sponsor
- Tiziana Life Sciences LTD
- Conditions
- Thymic Carcinoma
- Interventions
- Milciclib Maleate
- First posted
- 2009-11-11
- Last updated
- 2019-02-06
- Other registries' IDs
- eudract:2009-014338-79
- Results first posted
- 2018-10-16
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival Rate at 3 Months | 3 months since treatment start | The proportion of successes (i.e. patients alive and progression free at 3 months since treatment start) out of the total number of evaluable patients |
| Secondary | Confirmed Objective Response Rate (ORR) | Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD. | Point and 95% confidence interval estimates was calculated for the objective tumor response rate (confirmed CRs or PRs). The determination of antitumor efficacy was based on objective tumor assessments made according to the RECIST guideline (version 1.1) The analysis was performed in the evaluable population. |
| Secondary | Disease Control Rate | Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD. | Point and 95% confidence interval estimates was calculated for the disease control rate (confirmed CRs / PRs and SD\>/= 6 weeks). The analysis was performed in the evaluable populations. |
| Secondary | Progression-free Survival | Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD. | The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works. |
| Secondary | Duration of Response | Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD. | Assessed in patients achieving a confirmed objective tumor response by RECIST version 1.1 criteria. |
| Secondary | Overall Survival | Every 6 weeks during Follow-Up until PD or new therapy start; every 6 months thereafter, up to 2 years from the last dose of study drug. | The length of time from the start of treatment for a disease, such as cancer, to the date in which the patients diagnosed with the disease were still alive. |
| Secondary | Overall Safety Profile (Adverse Events (NCI CTCAE) and Hematological and Blood Chemistry Parameters) | Adverse events: from date treatment consent signed to 28 days after last dose of study drug; hematology/blood chemistry tests: at baseline and between Day 11-14 of each cycle of a total of 135 two-week cycles. | The adverse events (AEs) were coded with the Medical Dictionary for Regulatory Activities (MedDRA) and their severity graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The following subsets of AEs were considered: serious AEs, AEs with CTCAE grade 3-5, AEs with a relationship to study treatment classified by the Investigator as possible or probable or definite and AEs reported as leading to discontinuation from treatment. Laboratory test values were graded according to the NCI CTCAE scale, v3.0, whenever possible. For each laboratory test included in the NCI CTCAE system, the incidence of abnormalities was evaluated by considering the worst occurrence for each patient throughout the whole treatment period. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival Rate at 3 Months | 3 months since treatment start | Evaluable patients: population consisting of all treated patients who fulfill the following conditions:~* histological confirmation of thymic carcinoma by an Independent Review Committee~* received at least 80% of drug in the first two cycles overall~* baseline and \>/= 1 on treatment tumor assessment or die before tumor re-assessment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Confirmed Objective Response Rate (ORR) | Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD. | Evaluable patients | Percentage of patients | NUMBER |
| SECONDARY | Disease Control Rate | Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD. | Evaluable patients | Percentage of patients | NUMBER |
| SECONDARY | Progression-free Survival | Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD. | Evaluable patients | Months | MEDIAN |
| SECONDARY | Duration of Response | Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD. | Months | MEDIAN | |
| SECONDARY | Overall Survival | Every 6 weeks during Follow-Up until PD or new therapy start; every 6 months thereafter, up to 2 years from the last dose of study drug. | Evaluable patients | Months | MEDIAN |
| SECONDARY | Overall Safety Profile (Adverse Events (NCI CTCAE) and Hematological and Blood Chemistry Parameters) | Adverse events: from date treatment consent signed to 28 days after last dose of study drug; hematology/blood chemistry tests: at baseline and between Day 11-14 of each cycle of a total of 135 two-week cycles. | All treated patients | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival Rate at 3 Months | Milciclib Maleate (PHA-848125AC) | Success | 24 | Participants | |
| Progression-free Survival Rate at 3 Months | Milciclib Maleate (PHA-848125AC) | Failure | 30 | Participants | |
| Confirmed Objective Response Rate (ORR) | Milciclib Maleate (PHA-848125AC) | 3.7 | 95% Confidence Interval 0.45 to 12.75 | Percentage of patients | |
| Disease Control Rate | Milciclib Maleate (PHA-848125AC) | 75.9 | 95% Confidence Interval 62.36 to 86.51 | Percentage of patients | |
| Progression-free Survival | Milciclib Maleate (PHA-848125AC) | 6.83 | 95% Confidence Interval 4.11 to 8.71 | Months | |
| Duration of Response | Milciclib Maleate (PHA-848125AC) | 8.41 | 95% Confidence Interval 6.90 to 9.92 | Months | |
| Overall Survival | Milciclib Maleate (PHA-848125AC) | 24.18 | 95% Confidence Interval 16.89 to 36.57 | Months | |
| Overall Safety Profile (Adverse Events (NCI CTCAE) and Hematological and Blood Chemistry Parameters) | Milciclib Maleate (PHA-848125AC) | N° patients with Adverse Events | 72 | Participants | |
| Overall Safety Profile (Adverse Events (NCI CTCAE) and Hematological and Blood Chemistry Parameters) | Milciclib Maleate (PHA-848125AC) | N° patients with abnormal Hematology test | 70 | Participants | |
| Overall Safety Profile (Adverse Events (NCI CTCAE) and Hematological and Blood Chemistry Parameters) | Milciclib Maleate (PHA-848125AC) | N° patients with abnormal Blood Chemistry test | 70 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Milciclib Maleate (PHA-848125AC) | 72 | |
| Overall Study | COMPLETED | Milciclib Maleate (PHA-848125AC) | 15 | |
| Overall Study | NOT COMPLETED | Milciclib Maleate (PHA-848125AC) | 57 |
Source ClinicalTrials.gov
Adverse events83
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 | Nausea | Gastrointestinal disorders | Milciclib Maleate (PHA-848125AC) | 65 | 72 | 448 |
| other | Diarrhoea NOS | Gastrointestinal disorders | Milciclib Maleate (PHA-848125AC) | 56 | 72 | 457 |
| other | Vomiting NOS | Gastrointestinal disorders | Milciclib Maleate (PHA-848125AC) | 47 | 72 | 192 |
| other | Abdominal pain NOS | Gastrointestinal disorders | Milciclib Maleate (PHA-848125AC) | 11 | 72 | 28 |
| other | Abdominal pain upper | Gastrointestinal disorders | Milciclib Maleate (PHA-848125AC) | 8 | 72 | 10 |
| other | Constipation | Gastrointestinal disorders | Milciclib Maleate (PHA-848125AC) | 8 | 72 | 15 |
| other | Dysphagia | Gastrointestinal disorders | Milciclib Maleate (PHA-848125AC) | 4 | 72 | 4 |
| other | Stomatitis | Gastrointestinal disorders | Milciclib Maleate (PHA-848125AC) | 4 | 72 | 5 |
| other | Asthenia | General disorders | Milciclib Maleate (PHA-848125AC) | 48 | 72 | 249 |
| other | Chest pain | General disorders | Milciclib Maleate (PHA-848125AC) | 14 | 72 | 30 |
1 to 10 of 83Source ClinicalTrials.gov
See all 83 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Milciclib Maleate (PHA-848125AC) | 37 | 72 |
| Total, other adverse events | Milciclib Maleate (PHA-848125AC) | 72 | 72 |
| Total, serious adverse events | Milciclib Maleate (PHA-848125AC) | 22 | 72 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01011439
GET https://conductscience.org/api/trials/v1/NCT01011439/events?page=2