Trial · NCT02567656
Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma
NCT02567656, Phase 1, Completed, Rhizen Pharmaceuticals SA; results first posted 2020-01-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma. Trials, record NCT02567656. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02567656
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma
- NCT number
- NCT02567656
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 58 participants, actual
- Lead sponsor
- Rhizen Pharmaceuticals SA
- Conditions
- Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell, Cutaneous
- Interventions
- RP6530
- First posted
- 2015-10-05
- Last updated
- 2020-01-13
- Results first posted
- 2020-01-13
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety of RP6530 | 28 days | Number of participants with Treatment-Related Adverse Events as Assessed by CTACE v4.0 |
| Secondary | Overall Response Rate (ORR) With RP6530 | 8 months | ORR is defined as sum of CR and PR rates, Response assessment for PTCL based on IWG criteria (Cheson 2007) and CTCL on mSWAT/Global assessment (ISCL/EORTC guideline). |
| Secondary | Duration of Response (DOR) With RP6530 | 24 months | The time period from the response achieved in patient until the disease progression. |
| Secondary | Peak Plasma Concentration (Cmax) | Day 1 of Cycle 1 | Peak Plasma Concentration (Cmax) of RP6530 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety of RP6530 | 28 days | DLT assessment performed in patients who participated in dose escalation phase; A toxicity will be considered dose-limiting if it occurs during the first cycle (4-weeks) treatment with Tenalisib and is considered related to Tenalisib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response Rate (ORR) With RP6530 | 8 months | Patients were considered for efficacy analysis as per protocol only if they had one post treatment efficacy assessment at C3D1 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) With RP6530 | 24 months | Duration of Response (DoR) is defined as the time when the measurement criteria are first met for PR or CR (whichever is reported first) until the date of documented disease progression or death. Overall number of Participants analyzed for DoR will be the participants who met response as CR or PR | Days | MEDIAN |
| SECONDARY | Peak Plasma Concentration (Cmax) | Day 1 of Cycle 1 | Peak Plasma Concentration (Cmax) of RP6530 at Cycle 1 day 1 | ng/mL | MEAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety of RP6530 | Dose escalation_Cohort 1_200 mg | No.of Participants with Dose Limiting Toxicities | 0 | Participants | |
| Safety of RP6530 | Dose escalation_Cohort 2_400 mg | No.of Participants with Dose Limiting Toxicities | 0 | Participants | |
| Safety of RP6530 | Dose escalation_Cohort 3_800 mg (Fasting) | No.of Participants with Dose Limiting Toxicities | 0 | Participants | |
| Safety of RP6530 | Dose escalation_Cohort 4_800 mg (Fed) | No.of Participants with Dose Limiting Toxicities | 2 | Participants | |
| Safety of RP6530 | Dose expansion_PTCL_800 mg (Fasting) | No.of Participants with Dose Limiting Toxicities | 0 | Participants | |
| Safety of RP6530 | Dose expansion_CTCL_800 mg (Fasting) | No.of Participants with Dose Limiting Toxicities | 0 | Participants | |
| Safety of RP6530 | Dose escalation_Cohort 1_200 mg | No.of Participants without Dose Limiting Toxicitie | 4 | Participants | |
| Safety of RP6530 | Dose escalation_Cohort 2_400 mg | No.of Participants without Dose Limiting Toxicitie | 4 | Participants | |
| Safety of RP6530 | Dose escalation_Cohort 3_800 mg (Fasting) | No.of Participants without Dose Limiting Toxicitie | 5 | Participants | |
| Safety of RP6530 | Dose escalation_Cohort 4_800 mg (Fed) | No.of Participants without Dose Limiting Toxicitie | 4 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose escalation_Cohort 1_200 mg | 4 | |
| Overall Study | STARTED | Dose escalation_Cohort 2_400 mg | 4 | |
| Overall Study | STARTED | Dose escalation_Cohort 3_800 mg (Fasting) | 5 | |
| Overall Study | STARTED | Dose escalation_Cohort 4_800 mg (Fed) | 6 | |
| Overall Study | STARTED | Dose expansion_PTCL_800 mg (Fasting) | 19 | |
| Overall Study | STARTED | Dose expansion_CTCL_800 mg (Fasting) | 20 | |
| Overall Study | COMPLETED | Dose escalation_Cohort 1_200 mg | 3 | |
| Overall Study | COMPLETED | Dose escalation_Cohort 2_400 mg | 3 | |
| Overall Study | COMPLETED | Dose escalation_Cohort 3_800 mg (Fasting) | 3 | |
| Overall Study | COMPLETED | Dose escalation_Cohort 4_800 mg (Fed) | 6 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events156
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 | Alanine aminotransferase increased | Investigations | Dose escalation_Cohort 1_200 mg | 1 | 4 | 2 |
| other | Alanine aminotransferase increased | Investigations | Dose escalation_Cohort 2_400 mg | 0 | 4 | 0 |
| other | Alanine aminotransferase increased | Investigations | Dose escalation_Cohort 3_800 mg (Fasting) | 2 | 5 | 3 |
| other | Alanine aminotransferase increased | Investigations | Dose escalation_Cohort 4_800 mg (Fed) | 3 | 6 | 3 |
| other | Alanine aminotransferase increased | Investigations | Dose expansion_PTCL_800 mg (Fasting) | 4 | 19 | 5 |
| other | Alanine aminotransferase increased | Investigations | Dose expansion_CTCL_800 mg (Fasting) | 8 | 20 | 13 |
| other | Aspartate aminotransferase increased | Investigations | Dose escalation_Cohort 1_200 mg | 1 | 4 | 3 |
| other | Aspartate aminotransferase increased | Investigations | Dose escalation_Cohort 2_400 mg | 0 | 4 | 0 |
| other | Aspartate aminotransferase increased | Investigations | Dose escalation_Cohort 3_800 mg (Fasting) | 2 | 5 | 2 |
| other | Aspartate aminotransferase increased | Investigations | Dose escalation_Cohort 4_800 mg (Fed) | 3 | 6 | 10 |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose escalation_Cohort 1_200 mg | 0 | 4 |
| Total, all-cause mortality | Dose escalation_Cohort 2_400 mg | 1 | 4 |
| Total, all-cause mortality | Dose escalation_Cohort 3_800 mg (Fasting) | 1 | 5 |
| Total, all-cause mortality | Dose escalation_Cohort 4_800 mg (Fed) | 1 | 6 |
| Total, all-cause mortality | Dose expansion_PTCL_800 mg (Fasting) | 3 | 19 |
| Total, all-cause mortality | Dose expansion_CTCL_800 mg (Fasting) | 1 | 20 |
| Total, other adverse events | Dose escalation_Cohort 1_200 mg | 4 | 4 |
| Total, other adverse events | Dose escalation_Cohort 2_400 mg | 3 | 4 |
| Total, other adverse events | Dose escalation_Cohort 3_800 mg (Fasting) | 5 | 5 |
| Total, other adverse events | Dose escalation_Cohort 4_800 mg (Fed) | 5 | 6 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
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/NCT02567656
GET https://conductscience.org/api/trials/v1/NCT02567656/results?page=2