Trial Outcomes & Findings for A Study of the Drugs Talazoparib and Temozolomide in Prostate Cancer (NCT NCT04019327)
NCT ID: NCT04019327
Last Updated: 2026-08-24
Results Overview
Toxicities will be classified by severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5 (NCI CTCAE v5.0).
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
16 participants
Primary outcome timeframe
30 days after last dose of study treatment (+/- 3 days), up to 1 year
Results posted on
2026-08-24
Participant Flow
Participant milestones
| Measure |
Dose Level 1 Tala 1mg, TMX 37.5 mg/m^2
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
Dose Level 1A Tala 0.75mg, TMX 50 mg/m^2
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
Dose Level 1B Tala 1mg, TMX 50 mg/m^2
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
Dose Level 2 Tala 1mg, TMX 75 mg/m^2
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
7
|
|
Overall Study
COMPLETED
|
0
|
2
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
1
|
4
|
Reasons for withdrawal
| Measure |
Dose Level 1 Tala 1mg, TMX 37.5 mg/m^2
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
Dose Level 1A Tala 0.75mg, TMX 50 mg/m^2
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
Dose Level 1B Tala 1mg, TMX 50 mg/m^2
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
Dose Level 2 Tala 1mg, TMX 75 mg/m^2
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
|---|---|---|---|---|
|
Overall Study
Death
|
3
|
1
|
1
|
3
|
|
Overall Study
Study terminated by sponsor
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of the Drugs Talazoparib and Temozolomide in Prostate Cancer
Baseline characteristics by cohort
| Measure |
Dose Level 1 Tala 1mg, TMX 37.5 mg/m^2
n=3 Participants
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
Dose Level 1A Tala 0.75mg, TMX 50 mg/m^2
n=3 Participants
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
Dose Level 1B Tala 1mg, TMX 50 mg/m^2
n=3 Participants
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
Dose Level 2 Tala 1mg, TMX 75 mg/m^2
n=7 Participants
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=1541 Participants
|
1 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
0 Participants
n=113 Participants
|
1 Participants
n=793 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1541 Participants
|
0 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
2 Participants
n=113 Participants
|
2 Participants
n=793 Participants
|
|
Age, Continuous
|
66 years
n=1541 Participants
|
58 years
n=1121 Participants
|
70 years
n=2662 Participants
|
62 years
n=113 Participants
|
64 years
n=793 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=1541 Participants
|
0 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
0 Participants
n=113 Participants
|
0 Participants
n=793 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=1541 Participants
|
3 Participants
n=1121 Participants
|
3 Participants
n=2662 Participants
|
7 Participants
n=113 Participants
|
16 Participants
n=793 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=1541 Participants
|
2 Participants
n=1121 Participants
|
3 Participants
n=2662 Participants
|
5 Participants
n=113 Participants
|
13 Participants
n=793 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1541 Participants
|
0 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
0 Participants
n=113 Participants
|
0 Participants
n=793 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1541 Participants
|
0 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
0 Participants
n=113 Participants
|
0 Participants
n=793 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1541 Participants
|
0 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
0 Participants
n=113 Participants
|
0 Participants
n=793 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=1541 Participants
|
0 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
1 Participants
n=113 Participants
|
2 Participants
n=793 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=1541 Participants
|
3 Participants
n=1121 Participants
|
3 Participants
n=2662 Participants
|
5 Participants
n=113 Participants
|
13 Participants
n=793 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1541 Participants
|
0 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
0 Participants
n=113 Participants
|
0 Participants
n=793 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1541 Participants
|
0 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
1 Participants
n=113 Participants
|
1 Participants
n=793 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=1541 Participants
|
3 Participants
n=1121 Participants
|
3 Participants
n=2662 Participants
|
7 Participants
n=113 Participants
|
16 Participants
n=793 Participants
|
PRIMARY outcome
Timeframe: 30 days after last dose of study treatment (+/- 3 days), up to 1 yearToxicities will be classified by severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5 (NCI CTCAE v5.0).
Outcome measures
| Measure |
Dose Level 2 Tala 1mg, TMX 75 mg/m^2
n=7 Participants
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
Dose Level 1 Tala 1mg, TMX 37.5 mg/m^2
n=3 Participants
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
Dose Level 1A Tala 0.75mg, TMX 50 mg/m^2
n=3 Participants
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
Dose Level 1B Tala 1mg, TMX 50 mg/m^2
n=3 Participants
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
|---|---|---|---|---|
|
Phase I: Number of Toxicities From Participants Evaluated for Treatment-Emergent Adverse Events/Toxicities [Safety and Tolerability])
|
95 toxicities
|
10 toxicities
|
16 toxicities
|
25 toxicities
|
PRIMARY outcome
Timeframe: 30 days after last dose of study treatment (+/- 3 days), up to 1 yearOverall best response rate (confirmed Complete Response/CR or Partial Response/PR) will be calculated according to RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Dose Level 2 Tala 1mg, TMX 75 mg/m^2
n=7 Participants
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
Dose Level 1 Tala 1mg, TMX 37.5 mg/m^2
n=3 Participants
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
Dose Level 1A Tala 0.75mg, TMX 50 mg/m^2
n=3 Participants
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
Dose Level 1B Tala 1mg, TMX 50 mg/m^2
n=3 Participants
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
|---|---|---|---|---|
|
Phase II: Overall Response Rate
CR or PR
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Phase II: Overall Response Rate
No CR or PR
|
7 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 30 days after last dose of study treatment (+/- 3 days), up to 1 yearReduction in PSA level of 50% or more compared to baseline as the best PSA response
Outcome measures
| Measure |
Dose Level 2 Tala 1mg, TMX 75 mg/m^2
n=7 Participants
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
Dose Level 1 Tala 1mg, TMX 37.5 mg/m^2
n=3 Participants
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
Dose Level 1A Tala 0.75mg, TMX 50 mg/m^2
n=3 Participants
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
Dose Level 1B Tala 1mg, TMX 50 mg/m^2
n=3 Participants
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
|---|---|---|---|---|
|
Phase II: Number of Participants With Reduction in PSA Level of 50% or More Compared to Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 30 days after last dose of study treatment (+/- 3 days), up to 1 yearCTC/Circulating tumor cell zero count, which is indicated as a reduction in the number of CTCs from 1 or more per 7.5 mL of blood at baseline to 0 per 7.5 mL during treatment using the CellSearch platform
Outcome measures
| Measure |
Dose Level 2 Tala 1mg, TMX 75 mg/m^2
n=7 Participants
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
Dose Level 1 Tala 1mg, TMX 37.5 mg/m^2
n=3 Participants
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
Dose Level 1A Tala 0.75mg, TMX 50 mg/m^2
n=3 Participants
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
Dose Level 1B Tala 1mg, TMX 50 mg/m^2
n=3 Participants
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
|---|---|---|---|---|
|
Phase II: Number of Participants With Circulating Tumor Cell (CTC) Response
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Dose Level 1 Tala 1mg, TMX 37.5 mg/m^2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Dose Level 1A Tala 0.75mg, TMX 50 mg/m^2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Dose Level 1B Tala 1mg, TMX 50 mg/m^2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Dose Level 2 Tala 1mg, TMX 75 mg/m^2
Serious events: 4 serious events
Other events: 7 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Dose Level 1 Tala 1mg, TMX 37.5 mg/m^2
n=3 participants at risk
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
Dose Level 1A Tala 0.75mg, TMX 50 mg/m^2
n=3 participants at risk
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
Dose Level 1B Tala 1mg, TMX 50 mg/m^2
n=3 participants at risk
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
Dose Level 2 Tala 1mg, TMX 75 mg/m^2
n=7 participants at risk
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
28.6%
2/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
57.1%
4/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
Other adverse events
| Measure |
Dose Level 1 Tala 1mg, TMX 37.5 mg/m^2
n=3 participants at risk
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
Dose Level 1A Tala 0.75mg, TMX 50 mg/m^2
n=3 participants at risk
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
Dose Level 1B Tala 1mg, TMX 50 mg/m^2
n=3 participants at risk
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
Dose Level 2 Tala 1mg, TMX 75 mg/m^2
n=7 participants at risk
Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair Temozolomide: Phase I maximum tolerated dose portion.
|
|---|---|---|---|---|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
28.6%
2/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
28.6%
2/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Cardiac disorders
Troponin I increased
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
42.9%
3/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
71.4%
5/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
28.6%
2/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Eye disorders
Blepharitis
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
66.7%
2/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
28.6%
2/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
General disorders
Chills
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
42.9%
3/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Metabolism and nutrition disorders
Decreased appetite
|
66.7%
2/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
42.9%
3/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
42.9%
3/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
28.6%
2/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
General disorders
Fatigue
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
66.7%
2/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
66.7%
2/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
71.4%
5/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
28.6%
2/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
42.9%
3/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
42.9%
3/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
28.6%
2/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
71.4%
5/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
66.7%
2/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
57.1%
4/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
28.6%
2/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
28.6%
2/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
General disorders
Pain
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
42.9%
3/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
66.7%
2/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
100.0%
7/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Investigations
Proteinuria
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
General disorders
Pyrexia
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
14.3%
1/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
33.3%
1/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
66.7%
2/3 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
57.1%
4/7 • 30 days after last dose of study treatment (+/- 3 days), up to 1 year
|
Additional Information
Dr. Karen Autio, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-422-4632
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place