TriangleNCT02264613 · OUTCOME
Evaluate the Safety and Tolerability of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas With Wild-type (WT) TP53 Who Are Refractory to or Intolerant of Standard Therapy, or for Whom no Standard Therapy Exists
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days
What was measured
Number of participants with treatment-related adverse events as assessed by CTCAE v.4.0
Groups in this outcome
Dose Regimen A (DR-A) Escalation (0.16 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
Dose Regimen A (DR-A) Escalation (0.32 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
Dose Regimen A (DR-A) Escalation (0.64 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
Dose Regimen A (DR-A) Escalation (1.25 mg/kg) Escalation
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
Dose Regimen A (DR-A) Escalation (2.10 mg/kg) Escalation
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
Dose Regimen A (DR-A) Escalation (3.10 mg/kg) Escalation
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
Dose Regimen A (DR-A) Escalation (4.40 mg/kg) Escalation
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
Dose Regimen B (DR-B) Escalation (0.32 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
Dose Regimen B (DR-B) Escalation (0.53 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
Dose Regimen B (DR-B) Escalation (0.80 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
Dose Regimen B (DR-B) Escalation (1.10 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
Dose Regimen B (DR-B) Escalation (1.50 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
Dose Regimen B (DR-B) Escalation (2.00 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
Dose Regimen B (DR-B) Escalation (2.70 mg/kg)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
Dose Regimen A (DR-A) PTCL Expansion
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
Dose Regimen C (DR-C) PTCL Expansion
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 3 and 5 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
Combination With Palbociclib Expansion (DR-A)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle Drug: Palbociclib Fixed-dose capsule administered orally on days 1 through 21 of a 28-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
| Group | Source count |
|---|---|
| Dose Regimen A (DR-A) Escalation (0.16 mg/kg) | 5 |
| Dose Regimen A (DR-A) Escalation (0.32 mg/kg) | 3 |
| Dose Regimen A (DR-A) Escalation (0.64 mg/kg) | 4 |
| Dose Regimen A (DR-A) Escalation (1.25 mg/kg) Escalation | 3 |
| Dose Regimen A (DR-A) Escalation (2.10 mg/kg) Escalation | 6 |
| Dose Regimen A (DR-A) Escalation (3.10 mg/kg) Escalation | 9 |
| Dose Regimen A (DR-A) Escalation (4.40 mg/kg) Escalation | 11 |
| Dose Regimen B (DR-B) Escalation (0.32 mg/kg) | 3 |
| Dose Regimen B (DR-B) Escalation (0.53 mg/kg) | 5 |
| Dose Regimen B (DR-B) Escalation (0.80 mg/kg) | 3 |
| Dose Regimen B (DR-B) Escalation (1.10 mg/kg) | 4 |
| Dose Regimen B (DR-B) Escalation (1.50 mg/kg) | 4 |
| Dose Regimen B (DR-B) Escalation (2.00 mg/kg) | 5 |
| Dose Regimen B (DR-B) Escalation (2.70 mg/kg) | 6 |
| Dose Regimen A (DR-A) PTCL Expansion | 21 |
| Dose Regimen C (DR-C) PTCL Expansion | 16 |
| Combination With Palbociclib Expansion (DR-A) | 34 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Regimen A (DR-A) Escalation (0.16 mg/kg) | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Regimen A (DR-A) Escalation (0.32 mg/kg) | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Regimen A (DR-A) Escalation (0.64 mg/kg) | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Regimen A (DR-A) Escalation (1.25 mg/kg) Escalation | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Regimen A (DR-A) Escalation (2.10 mg/kg) Escalation | 6 | Not reported | Not reported | Not reported | Not reported |
| Dose Regimen A (DR-A) Escalation (3.10 mg/kg) Escalation | 9 | Not reported | Not reported | Not reported | Not reported |
| Dose Regimen A (DR-A) Escalation (4.40 mg/kg) Escalation | 11 | Not reported | Not reported | Not reported | Not reported |
| Dose Regimen B (DR-B) Escalation (0.32 mg/kg) | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Regimen B (DR-B) Escalation (0.53 mg/kg) | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Regimen B (DR-B) Escalation (0.80 mg/kg) | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Regimen B (DR-B) Escalation (1.10 mg/kg) | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Regimen B (DR-B) Escalation (1.50 mg/kg) | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Regimen B (DR-B) Escalation (2.00 mg/kg) | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Regimen B (DR-B) Escalation (2.70 mg/kg) | 6 | Not reported | Not reported | Not reported | Not reported |
| Dose Regimen A (DR-A) PTCL Expansion | 21 | Not reported | Not reported | Not reported | Not reported |
| Dose Regimen C (DR-C) PTCL Expansion | 16 | Not reported | Not reported | Not reported | Not reported |
| Combination With Palbociclib Expansion (DR-A) | 34 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 11
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 11
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 4
- units
- Participants
- description
- Number of participants with treatment-related adverse events as assessed by CTCAE v.4.0
- groups
- description
- Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
- id
- OG000
- title
- Dose Regimen A (DR-A) Escalation (0.16 mg/kg)
- description
- Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
- id
- OG001
- title
- Dose Regimen A (DR-A) Escalation (0.32 mg/kg)
- description
- Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
- id
- OG002
- title
- Dose Regimen A (DR-A) Escalation (0.64 mg/kg)
- description
- Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
- id
- OG003
- title
- Dose Regimen A (DR-A) Escalation (1.25 mg/kg) Escalation
- description
- Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
- id
- OG004
- title
- Dose Regimen A (DR-A) Escalation (2.10 mg/kg) Escalation
- description
- Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
- id
- OG005
- title
- Dose Regimen A (DR-A) Escalation (3.10 mg/kg) Escalation
- description
- Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
- id
- OG006
- title
- Dose Regimen A (DR-A) Escalation (4.40 mg/kg) Escalation
- description
- Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
- id
- OG007
- title
- Dose Regimen B (DR-B) Escalation (0.32 mg/kg)
- description
- Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
- id
- OG008
- title
- Dose Regimen B (DR-B) Escalation (0.53 mg/kg)
- description
- Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
- id
- OG009
- title
- Dose Regimen B (DR-B) Escalation (0.80 mg/kg)
- description
- Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
- id
- OG010
- title
- Dose Regimen B (DR-B) Escalation (1.10 mg/kg)
- description
- Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
- id
- OG011
- title
- Dose Regimen B (DR-B) Escalation (1.50 mg/kg)
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days
- title
- Evaluate the Safety and Tolerability of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas With Wild-type (WT) TP53 Who Are Refractory to or Intolerant of Standard Therapy, or for Whom no Standard Therapy Exists
- type
- PRIMARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice