Trial · NCT02923986
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose Limiting Toxicity of BP1001 using non-hematologic and hematologic parameters per NCI CTCAE criteria | 240 days | Phase 1b portion of the study: Determine the dose limiting toxicity of BP1001 in combination with Das |
| Primary | Maximum Tolerated Dose of BP1001 using non-hematologic and hematologic parameters per NCI CTCAE criteria | 240 days | Phase 1b portion of the study: Determine the maximum tolerated dose of BP1001 in combination with Das |
| Primary | Efficacy of the combination of BP1001 and Das using hematologic response by bone marrow aspirate or biopsy and complete blood counts | 240 days | Phase IIa portion of the study: Assess the efficacy of the combination of BP1001 and Das |
| Primary | Efficacy of the combination of BP1001 and Das using cytogenetic response (karyotyping) by bone marrow aspirate or biopsy | 240 days | Phase IIa portion of the study: Assess the efficacy of the combination of BP1001 and Das |
| Primary | Efficacy of the combination of BP1001 and Das using molecular response (PCR) by bone marrow aspirate or biopsy | 240 days | Phase IIa portion of the study: Assess the efficacy of the combination of BP1001 and Das |
| Secondary | Safety of BP1001 in combination with Das using non-hematologic and hematologic parameters per NCI CTCAE criteria | 30 days | Evaluate Safety of BP1001 in combination with Das |
| Secondary | Efficacy of the combination of BP1001 and Das using hematologic response by bone marrow aspirate or biopsy and complete blood counts versus Das alone by historical outcome comparison | 240 days | Determine whether the combination of BP1001 and Das provides greater efficacy (Hematologic Response) than Das alone (by historical comparison) |
| Secondary | Efficacy of the combination of BP1001 and Das using cytogenetic response (karyotyping) by bone marrow aspirate or biopsy versus Das alone by historical outcome comparison | 240 days | Determine whether the combination of BP1001 and Das provides greater efficacy (Cytogenetic Response) than Das alone (by historical comparison) |
| Secondary | Efficacy of the combination of BP1001 and Das using molecular response (PCR) by bone marrow aspirate or biopsy versus Das alone by historical outcome comparison | 240 days | Determine whether the combination of BP1001 and Das provides greater efficacy (Molecular Response) than Das alone (by historical comparison) |
| Secondary | In vivo PK using plasma to compute half life and elimination | 30 days | Evaluate in vivo PK of BP1001 when given alone and in combination with Das |
| Secondary | Time to Response using hematologic response using bone marrow biopsy or aspirate and complete blood counts | 30 days | Assess time to response from administration of BP1001 + Das to hematologic response |
| Secondary | Time to Response using cytogenetic response (karyotyping) using bone marrow biopsy or aspirate | 30 days | Assess time to response from administration of BP1001 + Das to cytogenetic response |
| Secondary | Time to Response using molecular response (PCR) using bone marrow biopsy or aspirate | 30 days | Assess time to response from administration of BP1001 + Das to molecular response |
| Secondary | Duration of Response using hematologic response using bone marrow biopsy or aspirate and complete blood counts from day of response to day of disease progression | 30 days | Assess duration of response from day of response to day of disease progression |
| Secondary | Duration of Response using cytogenetic response (karyotyping) using bone marrow biopsy or aspirate from day of response to day of disease progression | 30 days | Assess duration of response from day of response to day of disease progression |
| Secondary | Duration of Response using molecular response (PCR) using bone marrow biopsy or aspirate from day of response to day of disease progression | 30 days | Assess duration of response from day of response to day of disease progression |
| Secondary | Overall Survival from date of study entry to study closure | 240 days | Assess overall survival from date of study entry to study closure |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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