Study Of Oral PHA-848125AC In Patients With Malignant Thymoma Previously Treated With Multiple Lines Of Chemotherapy

• Sponsor: Tiziana Life Sciences, PLC (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01301391
• Collaborator: (none)
• Enrollment: 30
• Locations: 3
• Arm: 1
• Actual Duration (Months): 94.5
• Patients Per Site: 10
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The intent of the study is to assess the antitumor activity of PHA-848125AC in patients with recurrent or metastatic, unresectable malignant thymoma previously treated with multiple lines of chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Malignant Thymoma	Drug: Milciclib Maleate	Phase 2

Detailed Description

This is a single-arm, open-label, multicenter, phase II clinical trial design with an early stopping rules. PHA-848125AC will be administered to patients with recurrent metastatic unresectable B3 thymoma or thymic carcinoma who have received more than one line of prior systemic therapy for advanced / metastatic disease. The intent of the study is to assess the antitumor activity of PHA-848125AC and ultimately to improve the outcome of the patients. The primary end point for this study is a progression free survival rate of 3 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study Of Oral PHA-848125AC In Patients With Malignant Thymoma Previously Treated With Multiple Lines Of Chemotherapy
• Actual Study Start Date: Feb 2, 2011
• Actual Primary Completion Date: May 31, 2017
• Actual Study Completion Date: Dec 17, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Milciclib Milciclib Maleate capsules	Drug: Milciclib Maleate; 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle. Number of cycles: until disease progression or unacceptable toxicity.; Other Names: PHA-848125AC

Outcome Measures

Primary Outcome Measures

1. Progression-free Survival Rate at 3 Months [3 months since treatment start]

   The proportion of successes (i.e. patients alive and progression-free at 3 months since treatment start) out of the total number of evaluable patients.

Secondary Outcome Measures

1. Adverse Events (NCI CTCAE) and Hematological and Blood Chemistry Parameters [Adverse events: from date treatment consent signed to 28 days after last treatment; hematology/blood chemistry tests: at baseline and between Day 11-14 of each cycle of a maximum total of 48 two-week cycles.]

   The adverse events (AEs) were coded with the Medical Dictionary for Regulatory Activities (MedDRA) and their severity graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The following subsets of AEs were considered: serious AEs, AEs with CTCAE grade 3-5, AEs with a relationship to study treatment classified by the Investigator as possible or probable or definite and AEs reported as leading to discontinuation from treatment. Laboratory test values were graded according to the NCI CTCAE scale, v3.0, whenever possible. For each laboratory test included in the NCI CTCAE system, the incidence of abnormalities were evaluated by considering the worst occurrence for each patient throughout the whole treatment period.

2. Objective Response Rate (ORR) [Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks.]

   Point and 95% confidence interval estimates was calculated for the objective tumor response rate (confirmed CRs or PRs). The determination of antitumor efficacy was based on objective tumor assessments made according to the RECIST guideline (version 1.1). The analysis was performed in the evaluable population.

3. Disease Control Rate (ORR+SD Rate) [Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks.]

   Point and 95% confidence interval estimates was calculated for the disease control rate (confirmed CRs / PRs and SD > or = 6 weeks). The analysis was performed in the evaluable patient populations.

4. Duration of Response [Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks.]

   Calculated in patients achieving a confirmed objective tumor response by RECIST version 1.1 criteria.

5. Overall Survival [Every 6 weeks during Follow-Up until PD or new therapy start; every 6 months thereafter, up to 2 years from the last dose of study drug.]

   The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, and to the date in which the patients diagnosed with the disease are still alive. Kaplan-Meier estimates as percentage of patients alive.

6. Progression-free Survival (PFS) [Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks.]

   The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Signed and dated IRB/Approved Informed Consent

• Histologically or cytologically proven diagnosis of unresectable B3 thymoma or thymic carcinoma recurrent or progressing after more than one prior systemic therapy for advanced / metastatic disease

• Presence of measurable disease

• Age >=18 years old

• ECOG performance status 0-1

• Negative pregnancy test (if female in reproductive years)

• Use of effective contraceptive methods if men and women of child producing potential

• Adequate liver function Total Serum Bilirubin <=1.5 x upper limit of normal (ULN) Transaminases (AST/ALT) <=2.5ULN (if liver metastases are present, then <=5ULN is allowed) ALP <=2.5ULN (if liver and/or bone metastases are present, then <=5ULN is allowed)

• Adequate renal function Serum Creatinine <=ULN or Creatinine Clearance calculated by Cockcroft and Gault's formula > 60 mL/min

• Adequate hematologic status ANC >=1,500cells/mm3 Platelet Count >= 100,000cells/mm3 Hemoglobin >=9.0g/dL

• Two weeks must have elapsed since completion of prior chemotherapy, minor surgery, radiotherapy (provided that no more than 25% of bone marrow reserve has been irradiated)

• Resolution of all acute toxic effects of any prior treatments to NCI CTC (Version 3.0) grade <=1

Exclusion Criteria:

• Any of the following in the past 6 months: myocardial infarction, uncontrolled cardiac arrhythmia, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis

• Grade >1 retinopathy

• Known brain metastases

• Known active infections

• Pregnant or breast feeding women

• Diabetes mellitus uncontrolled

• Gastrointestinal disease that would impact on drug absorption

• Patients under treatment with anticoagulants or with coagulation disorders or with signs of hemorrhage at baseline

• Patients with previous history or current presence of neurological disorders (with the exception of myasthenia gravis), including epilepsy (although controlled by anticonvulsant therapy), Parkinson's disease and extra-pyramidal syndromes.

• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that make the patient inappropriate for entry into this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MedStar Georgetown University Hospital	Washington	District of Columbia	United States	20007
2	NIH, Center for Cancer Research, Medical Oncology	Bethesda	Maryland	United States	20892
3	Fondazione IRCCS Istituto Nazionale dei Tumori di Milano	Milano	(mi)	Italy	20133

Sponsors and Collaborators

• Tiziana Life Sciences, PLC

Investigators

• Principal Investigator: Arun Rajan, MD., National Cancer Institute (NCI)
• Principal Investigator: Marina C. Garassino, MD., Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
• Principal Investigator: Giuseppe Giaccone, MD, MedStar Gergetown University Hospital

Study Documents (Full-Text)

• Study Protocol - Mar 9, 2017
• Statistical Analysis Plan: CDKO-125a-007_ALG_V1 - Apr 22, 2013
• Statistical Analysis Plan: CDKO-125a-007_TLG_V1 - Apr 22, 2013

More Information

Publications

None provided.

• Responsible Party: Tiziana Life Sciences, PLC
• ClinicalTrials.gov Identifier: NCT01301391
• Other Study ID Numbers: CDKO-125a-007
• First Posted: Feb 23, 2011
• Last Update Posted: Feb 6, 2019
• Last Verified: Jan 1, 2019

• Keywords provided by Tiziana Life Sciences, PLC: B3 and C malignant thymoma
• Additional relevant MeSH terms: Thymoma; Thymus Neoplasms; Maleic acid

Study Results

Participant Flow

Recruitment Details	Subjects were enrolled from 02 Feb 2011 to 28 Jan 2016 by 2 centers in US and one in Italy.
Pre-assignment Detail	Four patients were screening failure.

Arm/Group Title	Milciclib
Arm/Group Description	Milciclib Maleate capsules Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle. Number of cycles: until disease progression or unacceptable toxicity.
Period Title: Overall Study
STARTED	30
COMPLETED	4
NOT COMPLETED	26

Baseline Characteristics

Arm/Group Title	Milciclib
Arm/Group Description	Milciclib Maleate capsules Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle. Number of cycles: until disease progression or unacceptable toxicity.
Overall Participants	30
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	24 80%
>=65 years	6 20%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.2 (11.3)
Sex: Female, Male (Count of Participants)
Female	15 50%
Male	15 50%
Race/Ethnicity, Customized (Count of Participants)
White	23 76.7%
Black	2 6.7%
Asian	3 10%
Not Listed	2 6.7%
Region of Enrollment (Count of Participants)
United States	15 50%
Italy	15 50%
World Health Organization classification (International Classification of Diseases) (Count of Participants)
B3 - Well Differentiated Thymic Carcinoma	17 56.7%
C - Thymic Carcinoma	13 43.3%
Tumor extent at study entry (Count of Participants)
Metastatic	30 100%
In situ	0 0%
Masaoka clinical staging at study entry (Count of Participants)
Stage I: Grossly and microscopically encapsulate	0 0%
Stage II: Thymoma invades beyond the capsule	0 0%
Stage III: Macroscopic invasion neighboring organs	0 0%
Stage IVA: Pleural or pericardial dissemination	7 23.3%
Stage IVB: Hematogenous or lymphatic dissemination	10 33.3%
Not assessed	6 20%
Not available	7 23.3%

Outcome Measures

1. Primary Outcome

Title	Progression-free Survival Rate at 3 Months
Description	The proportion of successes (i.e. patients alive and progression-free at 3 months since treatment start) out of the total number of evaluable patients.
Time Frame	3 months since treatment start

Outcome Measure Data

Analysis Population Description

Evaluable patients, i.e., consists of all eligible and treated patients who fulfill the following additional conditions: 1) they receive at least 80% of drug in the first two cycles overall; 2) they have baseline and > or = 1 on-treatment tumor/oncologic assessment(s) or die before tumor re-assessment.

Arm/Group Title	Milciclib
Arm/Group Description	Milciclib Maleate capsules Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle. Number of cycles: until disease progression or unacceptable toxicity.
Measure Participants	24
Success	13 43.3%
Failure	11 36.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Milciclib
	Comments	H0:p≤ 25% vs H1:p> 25% with an interesting PFS-3 rate of 50% (median PFS of 3 months), alpha=0.05 and beta=0.10, 30 evaluable patients are required for a single stage trial. If at the end of the trial 12 or more out of 30 evaluable patients are alive and progression-free at 3 months since the treatment start date, the null hypothesis are rejected. A Fleming multiple-testing procedure is applied. If >=4 successes out of the first 15 patients are observed, accrual will continue up to 30.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	A priori threshold for statistical significance = 0.05
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Single proportion
	Estimated Value	0.54
	Confidence Interval	(2-Sided) 95%; 0.33 to 0.74
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Adverse Events (NCI CTCAE) and Hematological and Blood Chemistry Parameters
Description	The adverse events (AEs) were coded with the Medical Dictionary for Regulatory Activities (MedDRA) and their severity graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The following subsets of AEs were considered: serious AEs, AEs with CTCAE grade 3-5, AEs with a relationship to study treatment classified by the Investigator as possible or probable or definite and AEs reported as leading to discontinuation from treatment. Laboratory test values were graded according to the NCI CTCAE scale, v3.0, whenever possible. For each laboratory test included in the NCI CTCAE system, the incidence of abnormalities were evaluated by considering the worst occurrence for each patient throughout the whole treatment period.
Time Frame	Adverse events: from date treatment consent signed to 28 days after last treatment; hematology/blood chemistry tests: at baseline and between Day 11-14 of each cycle of a maximum total of 48 two-week cycles.

Outcome Measure Data

Analysis Population Description

All treated patients

Arm/Group Title	Milciclib
Arm/Group Description	Milciclib Maleate capsules Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle. Number of cycles: until disease progression or unacceptable toxicity.
Measure Participants	30
N° patients with Adverse Events	30 100%
N° patients with abnormal Hematology test	28 93.3%
N° patients with abnormal Blood chemistry test	27 90%

3. Secondary Outcome

Title	Objective Response Rate (ORR)
Description	Point and 95% confidence interval estimates was calculated for the objective tumor response rate (confirmed CRs or PRs). The determination of antitumor efficacy was based on objective tumor assessments made according to the RECIST guideline (version 1.1). The analysis was performed in the evaluable population.
Time Frame	Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks.

Outcome Measure Data

Analysis Population Description

Evaluable population: the patient population consists of all eligible and treated patients who fulfill the following additional conditions: 1) they receive at least 80% of drug in the first two cycles overall; 2) they have baseline and > or = 1 on-treatment tumor/oncologic assessment(s) or die before tumor re-assessment.

Arm/Group Title	Milciclib
Arm/Group Description	Milciclib Maleate capsules Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle. Number of cycles: until disease progression or unacceptable toxicity.
Measure Participants	24
Number (95% Confidence Interval) [Percentage of patients]	4.2

4. Secondary Outcome

Title	Disease Control Rate (ORR+SD Rate)
Description	Point and 95% confidence interval estimates was calculated for the disease control rate (confirmed CRs / PRs and SD > or = 6 weeks). The analysis was performed in the evaluable patient populations.
Time Frame	Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks.

Outcome Measure Data

Analysis Population Description

Evaluable patients

Arm/Group Title	Milciclib
Arm/Group Description	Milciclib Maleate capsules Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle. Number of cycles: until disease progression or unacceptable toxicity.
Measure Participants	24
Number (95% Confidence Interval) [Percentage of patients]	83.3

5. Secondary Outcome

Title	Duration of Response
Description	Calculated in patients achieving a confirmed objective tumor response by RECIST version 1.1 criteria.
Time Frame	Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks.

Outcome Measure Data

Analysis Population Description

Patients achieving a confirmed objective tumor response by RECIST version 1.1 criteria.

Arm/Group Title	Milciclib
Arm/Group Description	Milciclib Maleate capsules Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle. Number of cycles: until disease progression or unacceptable toxicity.
Measure Participants	1
Number [Months]	2.76

6. Secondary Outcome

Title	Overall Survival
Description	The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, and to the date in which the patients diagnosed with the disease are still alive. Kaplan-Meier estimates as percentage of patients alive.
Time Frame	Every 6 weeks during Follow-Up until PD or new therapy start; every 6 months thereafter, up to 2 years from the last dose of study drug.

Outcome Measure Data

Analysis Population Description

Evaluable patients

Arm/Group Title	Milciclib
Arm/Group Description	Milciclib Maleate capsules Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle. Number of cycles: until disease progression or unacceptable toxicity.
Measure Participants	24
Number [percentage of patients dead at 21 months]	41.666

7. Secondary Outcome

Title	Progression-free Survival (PFS)
Description	The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works.
Time Frame	Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks.

Outcome Measure Data

Analysis Population Description

Evaluable patients

Arm/Group Title	Milciclib
Arm/Group Description	Milciclib Maleate capsules Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle. Number of cycles: until disease progression or unacceptable toxicity.
Measure Participants	24
Median (95% Confidence Interval) [Months]	9.76

Adverse Events

Time Frame	Adverse events were reported for patients from consent signed to 28 days after last dose of study drug. Individual patient adverse event reporting ranged from 5.1 weeks to 141.3 weeks with a median of 19.28 weeks.
Arm/Group Title	Milciclib
Arm/Group Description	Milciclib Maleate capsules Milciclib Maleate: 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle. Number of cycles: until disease progression or unacceptable toxicity.
All Cause Mortality
	Milciclib
	Affected / at Risk (%)	# Events
Total	13/30 (43.3%)
Serious Adverse Events
	Milciclib
	Affected / at Risk (%)	# Events
Total	14/30 (46.7%)
Cardiac disorders
Pericardial effusion	1/30 (3.3%)	1
Gastrointestinal disorders
Abdominal pain NOS	1/30 (3.3%)	1
Gastrointestinal obstruction NOS	1/30 (3.3%)	1
General disorders
Fatigue	1/30 (3.3%)	1
Pyrexia	1/30 (3.3%)	1
Hepatobiliary disorders
Hyperbilirubinaemia	1/30 (3.3%)	1
Infections and infestations
Pneumonia NOS	2/30 (6.7%)	2
Sepsis NOS	1/30 (3.3%)	1
Staphylococcal infection	1/30 (3.3%)	1
Injury, poisoning and procedural complications
Fracture	1/30 (3.3%)	1
Investigations
Alanine aminotransferase increased	1/30 (3.3%)	1
Aspartate aminotransferase increased	1/30 (3.3%)	1
Blood alkaline phosphatase NOS increased	1/30 (3.3%)	1
Blood bilirubin increased	1/30 (3.3%)	1
Metabolism and nutrition disorders
Hypoglycaemia	1/30 (3.3%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	1/30 (3.3%)	1
Myalgia	1/30 (3.3%)	1
Nervous system disorders
Extrapyramidal disorder	1/30 (3.3%)	1
Syncope	1/30 (3.3%)	1
Reproductive system and breast disorders
Epididymitis NOS	1/30 (3.3%)	1
Respiratory, thoracic and mediastinal disorders
Haemoptisys	2/30 (6.7%)	2
Cough	1/30 (3.3%)	1
Dyspnoea NOS	1/30 (3.3%)	1
Dyspnoea exertional	1/30 (3.3%)	1
Hypoxia	1/30 (3.3%)	1
Skin and subcutaneous tissue disorders
Erythema multiforme	1/30 (3.3%)	1
Sweating increased	1/30 (3.3%)	1
Vascular disorders
Deep vein thrombosis	1/30 (3.3%)	1
Other (Not Including Serious) Adverse Events
	Milciclib
	Affected / at Risk (%)	# Events
Total	28/30 (93.3%)
Blood and lymphatic system disorders
Anaemia	8/30 (26.7%)	8
Leukopenia	4/30 (13.3%)	5
Neutropenia	4/30 (13.3%)	7
Cardiac disorders
Tachycardia	2/30 (6.7%)	2
Ear and labyrinth disorders
Tinnitus	2/30 (6.7%)	3
Eye disorders
Conjunctivitis	2/30 (6.7%)	3
Ocular discomfort	2/30 (6.7%)	2
Photopsia	2/30 (6.7%)	3
Gastrointestinal disorders
Nausea	25/30 (83.3%)	92
Diarrhoea NOS	18/30 (60%)	70
Vomiting NOS	17/30 (56.7%)	66
Constipation	4/30 (13.3%)	4
Abdominal pain upper	3/30 (10%)	3
Abdominal pain NOS	2/30 (6.7%)	4
Dysphagia	2/30 (6.7%)	2
Gastrointestinal disorder NOS	2/30 (6.7%)	4
General disorders
Asthenia	11/30 (36.7%)	22
Fatigue	11/30 (36.7%)	17
Pyrexia	7/30 (23.3%)	9
Oedema peripheral	5/30 (16.7%)	5
Chest pain	3/30 (10%)	3
Pain NOS	2/30 (6.7%)	4
Pain exacerbated	2/30 (6.7%)	2
Infections and infestations
Influenza	3/30 (10%)	4
Investigations
Lipase increased	4/30 (13.3%)	11
Alanine aminotransferase increased	3/30 (10%)	5
Blood amylase increased	3/30 (10%)	6
Weight decreased	3/30 (10%)	3
Aspartate aminotransferase increased	2/30 (6.7%)	3
Lymphocyte count decreased	2/30 (6.7%)	5
Metabolism and nutrition disorders
Anorexia	8/30 (26.7%)	8
Appetite decreased NOS	2/30 (6.7%)	3
Dehydratation	2/30 (6.7%)	4
Hypokalaemia	2/30 (6.7%)	5
Hypomagnesaemia	2/30 (6.7%)	3
Hypophosphataemia	2/30 (6.7%)	4
Musculoskeletal and connective tissue disorders
Arthralgia	4/30 (13.3%)	5
Flank pain	2/30 (6.7%)	2
Muscle spasms	2/30 (6.7%)	5
Myalgia	2/30 (6.7%)	3
Nervous system disorders
Tremor	11/30 (36.7%)	30
Dizziness	7/30 (23.3%)	12
Paraesthesia	4/30 (13.3%)	5
Dysgeusia	3/30 (10%)	3
Haedache	3/30 (10%)	3
Psychiatric disorders
Anxiety	2/30 (6.7%)	2
Renal and urinary disorders
Azotaemia	2/30 (6.7%)	2
Respiratory, thoracic and mediastinal disorders
Cough	6/30 (20%)	8
Dyspnoea NOS	2/30 (6.7%)	2
Dyspnoea exertional	2/30 (6.7%)	2
Epistaxis	2/30 (6.7%)	2
Productive cough	2/30 (6.7%)	2
Skin and subcutaneous tissue disorders
Pruritus	3/30 (10%)	3
Rash maculo-papular	3/30 (10%)	5
Dry skin	2/30 (6.7%)	2
Nail disorder NOS	2/30 (6.7%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.