Trial · NCT03711604
Compassionate Use Study of Tenalisib (RP6530)
NCT03711604, Phase 1, Phase 2, Completed, Rhizen Pharmaceuticals SA; results first posted 2024-05-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Compassionate Use Study of Tenalisib (RP6530). Trials, record NCT03711604. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03711604
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Compassionate Use Study of Tenalisib (RP6530)
- NCT number
- NCT03711604
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Rhizen Pharmaceuticals SA
- Conditions
- Hematological Malignancies
- Interventions
- Tenalisib
- First posted
- 2018-10-18
- Last updated
- 2024-05-08
- Results first posted
- 2024-05-08
- Limitations and caveats
The primary purpose of this study is to offer patients, who completed a Rhizen-sponsored clinical study without progression, the opportunity to continue to receive Tenalisib on a compassion basis. Thus, the assessments were done in open-label manner.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment-related Adverse Events | 2 years | To evaluate the safety and tolerability of Tenalisib as single agent. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
| Primary | Time to Disease Progression | 2 years | Number of patients with a time to progression. The time to progression is calculated from the day of enrollment in the study to disease progression or death due to any cause. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment-related Adverse Events | 2 years | A total of 17 patients received at least one dose of Tenalisib. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Time to Disease Progression | 2 years | A total of 17 patients received at least one dose of Tenalisib. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment-related Adverse Events | Tenalisib (RP6530) | 4 | Participants | ||
| Time to Disease Progression | Tenalisib (RP6530) | 8.4 | Full Range 2.77 to 24.01 | Months |
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 | Tenalisib (RP6530) | 17 | |
| Overall Study | COMPLETED | Tenalisib (RP6530) | 17 | |
| Overall Study | NOT COMPLETED | Tenalisib (RP6530) | 0 |
Source ClinicalTrials.gov
Adverse events42
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 | Spinal cord compression | Nervous system disorders | Tenalisib (RP6530) | 1 | 17 | 1 |
| other | Post herpetic neuralgia | Nervous system disorders | Tenalisib (RP6530) | 1 | 17 | 1 |
| other | Peripheral neuropathy | Nervous system disorders | Tenalisib (RP6530) | 1 | 17 | 1 |
| other | Dysgeusia | Nervous system disorders | Tenalisib (RP6530) | 1 | 17 | 1 |
| other | Elevated Aspartate aminotransferase | Investigations | Tenalisib (RP6530) | 2 | 17 | 3 |
| other | Elevated Blood alkaline phosphotase | Investigations | Tenalisib (RP6530) | 2 | 17 | 5 |
| other | Neutrophile count decreased | Investigations | Tenalisib (RP6530) | 2 | 17 | 7 |
| other | Platelet count decreased | Investigations | Tenalisib (RP6530) | 2 | 17 | 9 |
| other | Elevated Troponin | Investigations | Tenalisib (RP6530) | 1 | 17 | 1 |
| other | Exfoliative Rash | Skin and subcutaneous tissue disorders | Tenalisib (RP6530) | 1 | 17 | 1 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tenalisib (RP6530) | 1 | 17 |
| Total, other adverse events | Tenalisib (RP6530) | 16 | 17 |
| Total, serious adverse events | Tenalisib (RP6530) | 5 | 17 |
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/NCT03711604
GET https://conductscience.org/api/trials/v1/NCT03711604/events?page=2