Trial · NCT02223598
A Phase 1 Study Evaluating CB-5083 in Subjects With Lymphoid Hematological Malignancies
NCT02223598, Phase 1, Terminated, Cleave Biosciences, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 1 Study Evaluating CB-5083 in Subjects With Lymphoid Hematological Malignancies. Trials, record NCT02223598. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02223598
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 1 Study Evaluating CB-5083 in Subjects With Lymphoid Hematological Malignancies
- NCT number
- NCT02223598
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 120 participants, estimated
- Lead sponsor
- Cleave Biosciences, Inc.
- Conditions
- Lymphoid Hematological Malignancies, Relapsed and Refractory Multiple Myeloma
- Interventions
- CB-5083, Dexamethasone
- First posted
- 2014-08-22
- Last updated
- 2018-02-27
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To determine the dose limiting toxicities (DLTs) of oral CB-5083 in subjects with lymphoid hematological malignancies | Dose Escalation Stage - the first 28 days of treatment (Cycle 1) with CB-5083 | |
| Primary | To determine the pharmacokinetic (PK) profile of oral CB-5083 in subjects with lymphoid hematological malignancies by measuring the AUC | Dose Escalation and Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 in the second 28 days (Cycle 2) of treatment with CB-5083 | |
| Primary | To determine the PK profile of oral CB-5083 in subjects with lymphoid hematological malignancies by measuring the Cmax | Dose Escalation and Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083 | |
| Primary | To determine the PK profile of oral CB-5083 in subjects with lymphoid hematological malignancies by measuring the Cmin | Dose Escalation and Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083 | |
| Primary | To determine the PK profile of oral CB-5083 in subjects with lymphoid hematological malignancies by measuring the Tmax | Dose Escalation and Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083 | |
| Primary | To determine the PK profile of oral CB-5083 in subjects with lymphoid hematological malignancies by measuring the T1/2 | Dose Escalation and Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083 | |
| Primary | To confirm the safety and tolerability of oral CB-5083 administered to subjects with relapsed and refractory Multiple Myeloma at the maximum tolerated dose (MTD) at the end of the Dose Escalation Stage | Dose Expansion Stage - from day 1 of Cycle 1 through 28 days after the patient's last cycle of treatment | |
| Primary | To confirm the safety and tolerability of oral CB-5083 administered to subjects with relapsed/refractory DLBCL or Waldenstrom Macroglobulinemia at the MTD | Dose Expansion Stage - from day 1 of Cycle 1 through 28 days after the patient's last cycle of treatment | |
| Secondary | To assess the pharmacodynamic (PD) effects of CB-5083 in peripheral blood cells and cancer cells | Dose Escalation and Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 | |
| Secondary | To further asses the PK profile of oral CB-5083 in subjects by measuring the AUC | Dose Expansion Stages - days 1, 2, 4 and 5 of Cycle 1 and days 1 and 2 of Cycle 2 of treatment with CB-5083 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT02223598
GET https://conductscience.org/api/trials/v1/NCT02223598/registered