Trial Outcomes & Findings for A Phase II Study to Evaluate Efficacy and Safety of P276-00 in Relapsed and/or Refractory Mantle Cell Lymphoma (NCT NCT00843050)
NCT ID: NCT00843050
Last Updated: 2012-07-27
Results Overview
The primary efficacy endpoint is the proportion of subjects achieving an objective response. The proportion of patients achieving an objective response is the best overall objective response rate.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
End of every 2 cycles and end of the study treatment
Results posted on
2012-07-27
Participant Flow
This study was conducted across multiple centers in the United States and India.
Participant milestones
| Measure |
P276-00
P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase II Study to Evaluate Efficacy and Safety of P276-00 in Relapsed and/or Refractory Mantle Cell Lymphoma
Baseline characteristics by cohort
| Measure |
P276-00
n=13 Participants
P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age Continuous
|
65.8 years
STANDARD_DEVIATION 9.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
|
Region of Enrollment
India
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of every 2 cycles and end of the study treatmentPopulation: The efficacy population includes all patients who have completed at least two cycles of P276-00 therapy and have tumor measurements.
The primary efficacy endpoint is the proportion of subjects achieving an objective response. The proportion of patients achieving an objective response is the best overall objective response rate.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of the study treatmentPopulation: The efficacy population includes all patients who have completed at least two cycles of P276-00 therapy and have tumor measurements.
It is defined as the time from when the measurement criteria are met for complete or partial response until the first date that recurrent or progressive disease is objectively or clinically documented.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of study treatmentPopulation: The efficacy population includes all patients who have completed at least two cycles of P276-00 therapy and have tumor measurements.
It is defined as the time from day 1 of the study drug administration until the first date of progressive disease.
Outcome measures
Outcome data not reported
Adverse Events
P276-00
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
P276-00
n=13 participants at risk
P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.7%
1/13 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Disease Progression
|
15.4%
2/13 • Number of events 2
|
|
Renal and urinary disorders
Elevated Creatinine,
|
7.7%
1/13 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
7.7%
1/13 • Number of events 1
|
|
Infections and infestations
Herpes Zoster
|
7.7%
1/13 • Number of events 1
|
Other adverse events
| Measure |
P276-00
n=13 participants at risk
P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
7.7%
1/13 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
23.1%
3/13 • Number of events 4
|
|
Psychiatric disorders
Anxiety
|
7.7%
1/13 • Number of events 1
|
|
Infections and infestations
Arthropod bite
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Ascites
|
7.7%
1/13 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
15.4%
2/13 • Number of events 2
|
|
General disorders
Asthenia
|
7.7%
1/13 • Number of events 1
|
|
Investigations
Blood Alkaline Phosphatase increased
|
7.7%
1/13 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
7.7%
1/13 • Number of events 1
|
|
Investigations
Blood lactate dehydrogenase increased
|
7.7%
1/13 • Number of events 1
|
|
Cardiac disorders
Cardiac murmur
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Chills
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
2/13 • Number of events 2
|
|
Gastrointestinal disorders
Decrreased Appetite
|
15.4%
2/13 • Number of events 2
|
|
General disorders
Dehydration
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
30.8%
4/13 • Number of events 6
|
|
Nervous system disorders
Dizziness
|
15.4%
2/13 • Number of events 2
|
|
Eye disorders
Dry Eye
|
7.7%
1/13 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
15.4%
2/13 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
15.4%
2/13 • Number of events 2
|
|
Cardiac disorders
Electrocardiogram QT prolonged
|
15.4%
2/13 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Fatigue
|
30.8%
4/13 • Number of events 5
|
|
Gastrointestinal disorders
Gastritis
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Headache
|
15.4%
2/13 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
hypertriglyceridemia
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
7.7%
1/13 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
hypokalemia
|
15.4%
2/13 • Number of events 2
|
|
Metabolism and nutrition disorders
hypomagnesaemia
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
hypophosphataemia
|
7.7%
1/13 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
46.2%
6/13 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
7.7%
1/13 • Number of events 1
|
|
Injury, poisoning and procedural complications
Injection site reaction
|
7.7%
1/13 • Number of events 1
|
|
Injury, poisoning and procedural complications
Injection site swelling
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Insomnia
|
15.4%
2/13 • Number of events 2
|
|
General disorders
Lymphadenopathy
|
7.7%
1/13 • Number of events 1
|
|
Cardiac disorders
Left atrial dilatation
|
7.7%
1/13 • Number of events 1
|
|
Investigations
lymphocyte count increased
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
7.7%
1/13 • Number of events 7
|
|
Gastrointestinal disorders
nausea
|
7.7%
1/13 • Number of events 1
|
|
Blood and lymphatic system disorders
neutropenia
|
7.7%
1/13 • Number of events 2
|
|
Investigations
neutrophil count decreased
|
7.7%
1/13 • Number of events 1
|
|
General disorders
nocturia
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Oedema
|
15.4%
2/13 • Number of events 4
|
|
General disorders
Oedema peripheral
|
38.5%
5/13 • Number of events 5
|
|
General disorders
pain
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Pain in extremity
|
15.4%
2/13 • Number of events 2
|
|
Nervous system disorders
Panic attack
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Penile swelling
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
7.7%
1/13 • Number of events 2
|
|
Investigations
Platelet count decreased
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
15.4%
2/13 • Number of events 2
|
|
Metabolism and nutrition disorders
Pollakiuria
|
7.7%
1/13 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post operative wound complication
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Pruritus
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Rash
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Rash Pruritic
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Rash pustular
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
7.7%
1/13 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
7.7%
1/13 • Number of events 2
|
|
General disorders
skin burning sensation
|
7.7%
1/13 • Number of events 1
|
|
General disorders
spleen palpable
|
7.7%
1/13 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
7.7%
1/13 • Number of events 1
|
|
Renal and urinary disorders
Urinary tract infection
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria papular
|
7.7%
1/13 • Number of events 1
|
|
Investigations
White blood cell count decreased
|
7.7%
1/13 • Number of events 1
|
|
Investigations
White blood cell count increased
|
7.7%
1/13 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place