A Phase I/Ib Safety and Efficacy Study of the PI3K-delta Inhibitor TGR-1202 and Ibrutinib in Patients With CLL or MCL
Sponsor
Dana-Farber Cancer Institute (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02268851
Collaborator
TG Therapeutics, Inc. (Industry), The Leukemia and Lymphoma Society (Other), Blood Cancer Research Partnership (Other)
45
6
2
107
7.5
0.1
Study Details
Study Description
Brief Summary
This research study will be evaluating the safety and efficacy of a study drug called TGR-1202 in combination with a known drug ibrutinib, also known as Imbruvica, as a possible treatment for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Mantle Cell Lymphoma (MCL) that has come back or that has not responded to standard treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
This research study is a Phase I and Ib combination clinical trial, which aims to both evaluate the safety of an investigational drug combination and also tries to define the appropriate dose of the investigational drug to evaluate in later clinical trials. "Investigational" means that the intervention is being studied. It also means that the FDA (U.S. Food and Drug Administration) has not approved TGR-1202 in the United States for use in MCL/CLL/SLL cancers.
TGR-1202 is a newly developed drug that may stop cancer cells from growing based on recent laboratory experiments. The results from these experiments suggest this drug may help to kill cancer cells when coupled with ibrutinib. In this research study, the safety and tolerability of TGR-1202 is being investigated to determine the highest dose that can safely be used in combination with ibrutinib. The study is also aimed to evaluate whether TGR-1202 has any effect on tumor growth (nodal response), and to determine the overall repsonse rate and duration of response in patients with CLL/SLL or MCL
Study Design
Study Type:
Interventional
Actual Enrollment
:
45 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multi-center Phase I/Ib Study Evaluating the Efficacy and Safety of the Novel PI3k Delta Inhibitor TGR-1202 in Combination With Ibrutinib in Patients With Select B-Cell Malignancies
Study Start Date
:
Nov 1, 2014
Actual Primary Completion Date
:
May 1, 2018
Anticipated Study Completion Date
:
Oct 1, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CLL Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. Each Cycle = 28 days TGR-1202 (oral): Starting on Day 1 administered daily. Ibrutinib (oral): Starting on Day 1 administered daily. |
Drug: TGR-1202
Capsules taken whole daily with water and with food
Other Names:
Drug: Ibrutinib
Capsules taken whole with water- Do not consume fish oil, vitamin E, grapefruit, or Seville oranges
Other Names:
|
| Experimental: MCL Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. Each Cycle = 28 days TGR-1202 (oral): Starting on Day 1 administered daily. Ibrutinib (oral): Starting on Day 1 administered daily. |
Drug: TGR-1202
Capsules taken whole daily with water and with food
Other Names:
Drug: Ibrutinib
Capsules taken whole with water- Do not consume fish oil, vitamin E, grapefruit, or Seville oranges
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Patients Who Experienced a Dose Limiting Toxicity (DLT) During Phase I [Participants were assessed every week or more often as needed during Cycle 1 or more often for up to 28 days to assess Dose-limiting toxicities (DLTs) during Phase I]
To assess the safety of TGR1202 in combination with ibrutinib relapsed or refractory CLL or MCL. DLT is based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. DLT refers to toxicities experienced at any time during the study treatment, defined as Grade 4 anemia; Grade 4 neutropenia lasting >7 days (while receiving growth factor support); Grade 4 thrombocytopenia lasting > 7 days; Grade ≥3 febrile neutropenia; and Grade ≥3 thrombocytopenia with Grade >2 hemorrhage;Grade ≥ 3 non-hematologic toxicity unresponsive to standard supportive care measure with the exception of asymptomatic Grade ≥3 lab abnormalities that resolve to ≤ Grade 1 or baseline within 7 days;treatment delay of ≥14 days due to unresolved toxicity; and non-hematologic toxicity of Grade 2 (at any time during treatment) that, in the judgment of the Investigators, Study Chair, and the Medical Monitor, is dose-limiting.
Secondary Outcome Measures
- Overall Response Rate [At baseline, End of Cycle 2, End of Cycle 5, End of Cycle 9, End of Cycle 14 and approximately q6 months until C26, then investigator discretion thereafter]
Response and progression will be evaluated in this study using the 2008 IW-CLL criteria for CLL (Hallek et al., 2008) by Lugano Criteria ( Cheson et al,.24) for MCL
- Rate of Nodal Response With Lymphocytosis (nPR) [2 years]
- Rate of Progression Free Survival [2 Years]
- Duration of Response [2 Years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Confirmed diagnosis of Mantle Cell Lymphoma (MCL), Chronic Lymphocytic Leukemia (CLL), or Small Lymphocytic Lymphoma (SLL)
-
Adequate organ system function ( Absolute neutrophil count, Platelets,Bilirubin, Platelets, Aspartate transferase ,Alanine aminotransferase, Creatinine Clearance)
-
Eastern Cooperative Group (ECOG) Performance status ≤ 2
-
Ability to swallow and retain oral medication
-
Female patients: must have negative serum pregnancy test at study screening/ all male partners must consent to use a medically acceptable method of contraception
-
Willingness and ability to comply with trial and follow-up procedures, and give written informed consent
Exclusion Criteria:-
-
Patients receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) within 3 weeks of Cycle 1/Day 1,
-
Autologous hematologic stem cell transplant within 3 months of study entry.
-
Allogeneic hematologic stem cell transplant within 12 months.
-
Post-allo patients must not have active graft versus-host disease
-
Evidence of active Hepatitis B,Hepatitis C or HIV infection.
-
Active central nervous system involvement by lymphoma
-
Requires treatment with strong CYP3A4/5 inhibitors
-
Severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
-
QTcF >470 msec (QT interval, Fredericia calculation)
-
Angina not well-controlled by medication
-
Poorly controlled or clinically significant atherosclerotic vascular disease
-
Presence of other active cancers, or history of treatment for invasive cancer within the past 2 years.
-
Require warfarin for anticoagulation
-
Women who are pregnant or lactating
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pacific Cancer Care | Monterey | California | United States | 93940 |
| 2 | St. Francis Hospital and Cancer Center | Hartford | Connecticut | United States | 06105 |
| 3 | Eastern Maine Medical Center/ Northern Light Cancer Care | Brewer | Maine | United States | 04412 |
| 4 | Dana Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
| 5 | Beth Israel Deaconness Medical Center | Boston | Massachusetts | United States | 02215 |
| 6 | West Michigan Cancer Center | Kalamazoo | Michigan | United States | 49007 |
Sponsors and Collaborators
- Dana-Farber Cancer Institute
- TG Therapeutics, Inc.
- The Leukemia and Lymphoma Society
- Blood Cancer Research Partnership
Investigators
- Principal Investigator: Matthew Davids, MD, Dana-Farber Cancer Institute
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Matthew S. Davids, MD,
Principal Investigators,
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT02268851
Other Study ID Numbers:
- 14-396
- TGR-IB-105
First Posted:
Oct 20, 2014
Last Update Posted:
Oct 4, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Matthew S. Davids, MD,
Principal Investigators,
Dana-Farber Cancer Institute
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants in the Phase I portion of the study enrolled in outpatient clinic setting from 11/20/2014 to 12/22/2018 and to the Phase II study from 1/14/2016 to 5/29/2018. The MCL and CLL arms were enrolled independently of each other, and were allowed to begin enrolling to the protocol scheduled expansion independent of the other arm. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | CLL: Phase I Cohort 1 | MCL: Phase I Cohort 1 | CLL: Phase I Cohort 2 | MCL: Phase I Cohort 2 | CLL: Phase I/II Cohort 3 (RPD2) | MCL: Phase I/II Cohort 3 (RPD2) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. | Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 560 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. | Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. | Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. | Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. | Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. |
| Period Title: Overall Study | ||||||
| STARTED | 3 | 3 | 4 | 3 | 15 | 15 |
| COMPLETED | 2 | 0 | 3 | 0 | 8 | 4 |
| NOT COMPLETED | 1 | 3 | 1 | 3 | 7 | 11 |
Baseline Characteristics
| Arm/Group Title | CLL: Phase I Cohort 1 | MCL: Phase 1 Cohort 1 | CLL: Phase I Cohort 2 | MCL: Phase I Cohort 2 | CLL Phase I/IICohort 3 (RPD2) | MCL Phase I/II Cohort 3 (RPD2) | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. | Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 560 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. | Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. | Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 560 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. | Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. | Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 560 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. | Total of all reporting groups |
| Overall Participants | 3 | 3 | 4 | 3 | 15 | 15 | 43 |
| Age (Count of Participants) | |||||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
3
100%
|
1
33.3%
|
2
50%
|
1
33.3%
|
2
13.3%
|
3
20%
|
12
27.9%
|
| >=65 years |
0
0%
|
2
66.7%
|
2
50%
|
2
66.7%
|
13
86.7%
|
12
80%
|
31
72.1%
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
2
66.7%
|
0
0%
|
3
75%
|
2
66.7%
|
5
33.3%
|
5
33.3%
|
17
39.5%
|
| Male |
1
33.3%
|
3
100%
|
1
25%
|
1
33.3%
|
10
66.7%
|
10
66.7%
|
26
60.5%
|
| Race (NIH/OMB) (Count of Participants) | |||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
1
33.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
2.3%
|
| White |
2
66.7%
|
3
100%
|
4
100%
|
2
66.7%
|
15
100%
|
15
100%
|
41
95.3%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
1
33.3%
|
0
0%
|
0
0%
|
1
2.3%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||||||
| United States |
3
100%
|
3
100%
|
4
100%
|
3
100%
|
15
100%
|
15
100%
|
43
100%
|
Outcome Measures
| Title | Number of Patients Who Experienced a Dose Limiting Toxicity (DLT) During Phase I |
|---|---|
| Description | To assess the safety of TGR1202 in combination with ibrutinib relapsed or refractory CLL or MCL. DLT is based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. DLT refers to toxicities experienced at any time during the study treatment, defined as Grade 4 anemia; Grade 4 neutropenia lasting >7 days (while receiving growth factor support); Grade 4 thrombocytopenia lasting > 7 days; Grade ≥3 febrile neutropenia; and Grade ≥3 thrombocytopenia with Grade >2 hemorrhage;Grade ≥ 3 non-hematologic toxicity unresponsive to standard supportive care measure with the exception of asymptomatic Grade ≥3 lab abnormalities that resolve to ≤ Grade 1 or baseline within 7 days;treatment delay of ≥14 days due to unresolved toxicity; and non-hematologic toxicity of Grade 2 (at any time during treatment) that, in the judgment of the Investigators, Study Chair, and the Medical Monitor, is dose-limiting. |
| Time Frame | Participants were assessed every week or more often as needed during Cycle 1 or more often for up to 28 days to assess Dose-limiting toxicities (DLTs) during Phase I |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients who have been previously treated for MCL, CLL or SLL. MCL must have 1 measurable site of disease and have had received at least one prior standard therapy; CLL/SLL patients must have an indication for treatment according to 2008 ICWLL criteria and received at least one prior standard treatment regimen |
| Arm/Group Title | CLL: Phase I Cohort 1 | MCL: Phase 1 Cohort 1 | CLL: Phase I Cohort 2 | MCL: Phase I Cohort 2 | CLL Phase I/IICohort 3 (RPD2) | MCL Phase I/II Cohort 3 (RPD2) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. | Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 560 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. | Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. | Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. | Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. | Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. |
| Measure Participants | 3 | 3 | 3 | 3 | 15 | 15 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Overall Response Rate |
|---|---|
| Description | Response and progression will be evaluated in this study using the 2008 IW-CLL criteria for CLL (Hallek et al., 2008) by Lugano Criteria ( Cheson et al,.24) for MCL |
| Time Frame | At baseline, End of Cycle 2, End of Cycle 5, End of Cycle 9, End of Cycle 14 and approximately q6 months until C26, then investigator discretion thereafter |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Rate of Nodal Response With Lymphocytosis (nPR) |
|---|---|
| Description | |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Rate of Progression Free Survival |
|---|---|
| Description | |
| Time Frame | 2 Years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Duration of Response |
|---|---|
| Description | |
| Time Frame | 2 Years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | Adverse events are assessed at minimum every week during cycle 1, on days 1 and 15 of cycle 2, every Day 1 of cycles 3-6 where every cycle is 28 days. Cycles 8-12, participants are evaluated every other cycle on Day 1, and then every 3 cycles Cycle 12 onward to Cycle 36, then every 6 cycles on Day 1 thereafter. The DLT period was the first 28 days of treatment during Phase I. AEs were assessed up to 30 days after drug discontinuation. | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Maximum grade toxicity by type-Serious AEs were defined as per DFCI criteria: Any grade 2 or 3 unexpected and treatment related event, unexpected grade 4 events, all grade 5 events regardless of attribution to study treatment. Includes events deemed medically important by overall PI. Other AEs were defined as events with the attribution of at least possibly related to the study treatment that did not meet the SAE criteria. CTCAE 4.0 was used in investigator assessment and lab value review. | |||||||||||
| Arm/Group Title | CLL: Phase I Cohort 1 | MCL: Phase I Cohort 1 | CLL: Phase I Cohort 2 | MCL: Phase I Cohort 2 | CLL: Phase I/IICohort 3 (RPD2) | MCL: Phase I/II Cohort 3 (RPD2) | ||||||
| Arm/Group Description | Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. | Phase I Cohort 1 patients received oral agent TGR1202 400mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 560 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. | Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. | Phase I Cohort 2 patients received oral agent TGR1202 600mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. | Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. | Phase I Cohort 3 patients received oral agent TGR1202 800mg daily on days 1-28 of a 28 day cycle and ibrutinib orally 420 mg daily on days 1-28 of a 28 day cycle. Patients are treated until progression without clinical benefit, toxicity, or withdrawal of consent by the patient, or closure of the trial by the Overall PI or regulatory authorities. | ||||||
All Cause Mortality |
||||||||||||
| CLL: Phase I Cohort 1 | MCL: Phase I Cohort 1 | CLL: Phase I Cohort 2 | MCL: Phase I Cohort 2 | CLL: Phase I/IICohort 3 (RPD2) | MCL: Phase I/II Cohort 3 (RPD2) | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/3 (33.3%) | 1/3 (33.3%) | 0/4 (0%) | 1/3 (33.3%) | 2/15 (13.3%) | 3/15 (20%) | ||||||
Serious Adverse Events |
||||||||||||
| CLL: Phase I Cohort 1 | MCL: Phase I Cohort 1 | CLL: Phase I Cohort 2 | MCL: Phase I Cohort 2 | CLL: Phase I/IICohort 3 (RPD2) | MCL: Phase I/II Cohort 3 (RPD2) | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/3 (66.7%) | 1/3 (33.3%) | 0/4 (0%) | 1/3 (33.3%) | 3/15 (20%) | 5/15 (33.3%) | ||||||
| Cardiac disorders | ||||||||||||
| Supraventricular Tachycardia | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/15 (0%) | 0 | 0/15 (0%) | 0 |
| General disorders | ||||||||||||
| Sudden Death | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 1/15 (6.7%) | 1 | 1/15 (6.7%) | 1 |
| Infections and infestations | ||||||||||||
| Sepsis | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/15 (0%) | 0 | 0/15 (0%) | 0 |
| Paraspinal Infection | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/15 (0%) | 0 | 1/15 (6.7%) | 1 |
| Fungal Pneumonia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/15 (0%) | 0 | 1/15 (6.7%) | 1 |
| Cellulitis | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/15 (0%) | 0 | 1/15 (6.7%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||
| Disease Progression | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 | 2/15 (13.3%) | 2 | 2/15 (13.3%) | 2 |
Other (Not Including Serious) Adverse Events |
||||||||||||
| CLL: Phase I Cohort 1 | MCL: Phase I Cohort 1 | CLL: Phase I Cohort 2 | MCL: Phase I Cohort 2 | CLL: Phase I/IICohort 3 (RPD2) | MCL: Phase I/II Cohort 3 (RPD2) | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/3 (100%) | 3/3 (100%) | 4/4 (100%) | 3/3 (100%) | 15/15 (100%) | 15/15 (100%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| Anemia | 2/3 (66.7%) | 3/3 (100%) | 3/4 (75%) | 2/3 (66.7%) | 15/15 (100%) | 7/15 (46.7%) | ||||||
| Leukocytosis | 2/3 (66.7%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 5/15 (33.3%) | 0/15 (0%) | ||||||
| Cardiac disorders | ||||||||||||
| Atrial fibrillation | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 3/15 (20%) | 1/15 (6.7%) | ||||||
| Ear and labyrinth disorders | ||||||||||||
| Hearing impaired | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 2/15 (13.3%) | 1/15 (6.7%) | ||||||
| Eye disorders | ||||||||||||
| Blurred vision | 1/3 (33.3%) | 0/3 (0%) | 1/4 (25%) | 1/3 (33.3%) | 3/15 (20%) | 1/15 (6.7%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| Abdominal pain | 1/3 (33.3%) | 1/3 (33.3%) | 1/4 (25%) | 0/3 (0%) | 1/15 (6.7%) | 2/15 (13.3%) | ||||||
| Bloating | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 1/15 (6.7%) | 2/15 (13.3%) | ||||||
| Colitis | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/15 (0%) | 2/15 (13.3%) | ||||||
| Constipation | 1/3 (33.3%) | 0/3 (0%) | 1/4 (25%) | 1/3 (33.3%) | 4/15 (26.7%) | 4/15 (26.7%) | ||||||
| Diarrhea | 2/3 (66.7%) | 3/3 (100%) | 2/4 (50%) | 3/3 (100%) | 10/15 (66.7%) | 12/15 (80%) | ||||||
| Dyspepsia | 1/3 (33.3%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 1/15 (6.7%) | 2/15 (13.3%) | ||||||
| Flatulence | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 1/3 (33.3%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Gastroesophageal reflux disease | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 3/3 (100%) | 2/15 (13.3%) | 5/15 (33.3%) | ||||||
| Gastrointestinal disorders - Other, specify | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 1/15 (6.7%) | 3/15 (20%) | ||||||
| Lip pain | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 2/15 (13.3%) | 1/15 (6.7%) | ||||||
| Mucositis oral | 1/3 (33.3%) | 1/3 (33.3%) | 1/4 (25%) | 0/3 (0%) | 1/15 (6.7%) | 2/15 (13.3%) | ||||||
| Nausea | 1/3 (33.3%) | 0/3 (0%) | 1/4 (25%) | 2/3 (66.7%) | 8/15 (53.3%) | 9/15 (60%) | ||||||
| Oral pain | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 1/15 (6.7%) | 1/15 (6.7%) | ||||||
| Stomach pain | 1/3 (33.3%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 2/15 (13.3%) | 0/15 (0%) | ||||||
| Toothache | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 1/15 (6.7%) | 1/15 (6.7%) | ||||||
| Vomiting | 1/3 (33.3%) | 0/3 (0%) | 1/4 (25%) | 1/3 (33.3%) | 2/15 (13.3%) | 5/15 (33.3%) | ||||||
| General disorders | ||||||||||||
| Edema limbs | 2/3 (66.7%) | 0/3 (0%) | 2/4 (50%) | 1/3 (33.3%) | 3/15 (20%) | 3/15 (20%) | ||||||
| Fatigue | 3/3 (100%) | 2/3 (66.7%) | 3/4 (75%) | 3/3 (100%) | 12/15 (80%) | 13/15 (86.7%) | ||||||
| Fever | 1/3 (33.3%) | 1/3 (33.3%) | 1/4 (25%) | 0/3 (0%) | 1/15 (6.7%) | 2/15 (13.3%) | ||||||
| Localized edema | 2/3 (66.7%) | 0/3 (0%) | 1/4 (25%) | 1/3 (33.3%) | 1/15 (6.7%) | 3/15 (20%) | ||||||
| Malaise | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 2/15 (13.3%) | 1/15 (6.7%) | ||||||
| Non-cardiac chest pain | 1/3 (33.3%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 1/15 (6.7%) | 1/15 (6.7%) | ||||||
| Pain | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 3/15 (20%) | 0/15 (0%) | ||||||
| Infections and infestations | ||||||||||||
| Infections and infestations - Other, specify | 0/3 (0%) | 0/3 (0%) | 3/4 (75%) | 0/3 (0%) | 1/15 (6.7%) | 1/15 (6.7%) | ||||||
| Lung infection | 0/3 (0%) | 0/3 (0%) | 2/4 (50%) | 0/3 (0%) | 5/15 (33.3%) | 4/15 (26.7%) | ||||||
| Nail infection | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 1/15 (6.7%) | 2/15 (13.3%) | ||||||
| Sinusitis | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 2/15 (13.3%) | 0/15 (0%) | ||||||
| Skin infection | 1/3 (33.3%) | 0/3 (0%) | 2/4 (50%) | 0/3 (0%) | 2/15 (13.3%) | 2/15 (13.3%) | ||||||
| Upper respiratory infection | 3/3 (100%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 6/15 (40%) | 1/15 (6.7%) | ||||||
| Urinary tract infection | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 2/15 (13.3%) | 0/15 (0%) | ||||||
| Injury, poisoning and procedural complications | ||||||||||||
| Bruising | 1/3 (33.3%) | 2/3 (66.7%) | 1/4 (25%) | 0/3 (0%) | 9/15 (60%) | 7/15 (46.7%) | ||||||
| Fall | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 3/15 (20%) | 2/15 (13.3%) | ||||||
| Investigations | ||||||||||||
| Alanine aminotransferase increased | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 2/15 (13.3%) | 3/15 (20%) | ||||||
| Alkaline phosphatase increased | 2/3 (66.7%) | 1/3 (33.3%) | 3/4 (75%) | 1/3 (33.3%) | 1/15 (6.7%) | 2/15 (13.3%) | ||||||
| Aspartate aminotransferase increased | 3/3 (100%) | 2/3 (66.7%) | 1/4 (25%) | 2/3 (66.7%) | 7/15 (46.7%) | 5/15 (33.3%) | ||||||
| Blood bilirubin increased | 1/3 (33.3%) | 0/3 (0%) | 2/4 (50%) | 1/3 (33.3%) | 3/15 (20%) | 4/15 (26.7%) | ||||||
| Creatinine increased | 1/3 (33.3%) | 1/3 (33.3%) | 1/4 (25%) | 1/3 (33.3%) | 5/15 (33.3%) | 3/15 (20%) | ||||||
| Lipase increased | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 1/15 (6.7%) | 1/15 (6.7%) | ||||||
| Lymphocyte count decreased | 0/3 (0%) | 1/3 (33.3%) | 2/4 (50%) | 1/3 (33.3%) | 1/15 (6.7%) | 6/15 (40%) | ||||||
| Lymphocyte count increased | 3/3 (100%) | 2/3 (66.7%) | 2/4 (50%) | 0/3 (0%) | 11/15 (73.3%) | 2/15 (13.3%) | ||||||
| Neutrophil count decreased | 1/3 (33.3%) | 3/3 (100%) | 2/4 (50%) | 0/3 (0%) | 13/15 (86.7%) | 7/15 (46.7%) | ||||||
| Platelet count decreased | 2/3 (66.7%) | 3/3 (100%) | 2/4 (50%) | 2/3 (66.7%) | 15/15 (100%) | 10/15 (66.7%) | ||||||
| Weight gain | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 4/15 (26.7%) | 2/15 (13.3%) | ||||||
| Weight loss | 0/3 (0%) | 1/3 (33.3%) | 2/4 (50%) | 0/3 (0%) | 0/15 (0%) | 2/15 (13.3%) | ||||||
| White blood cell decreased | 2/3 (66.7%) | 2/3 (66.7%) | 2/4 (50%) | 0/3 (0%) | 4/15 (26.7%) | 7/15 (46.7%) | ||||||
| Metabolism and nutrition disorders | ||||||||||||
| Anorexia | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 3/3 (100%) | 4/15 (26.7%) | 2/15 (13.3%) | ||||||
| Dehydration | 2/3 (66.7%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 1/15 (6.7%) | 1/15 (6.7%) | ||||||
| Hyperglycemia | 3/3 (100%) | 1/3 (33.3%) | 2/4 (50%) | 3/3 (100%) | 14/15 (93.3%) | 7/15 (46.7%) | ||||||
| Hyperkalemia | 0/3 (0%) | 1/3 (33.3%) | 1/4 (25%) | 1/3 (33.3%) | 1/15 (6.7%) | 3/15 (20%) | ||||||
| Hyperuricemia | 0/3 (0%) | 1/3 (33.3%) | 0/4 (0%) | 1/3 (33.3%) | 3/15 (20%) | 2/15 (13.3%) | ||||||
| Hypoalbuminemia | 1/3 (33.3%) | 1/3 (33.3%) | 2/4 (50%) | 3/3 (100%) | 4/15 (26.7%) | 4/15 (26.7%) | ||||||
| Hypocalcemia | 1/3 (33.3%) | 2/3 (66.7%) | 2/4 (50%) | 2/3 (66.7%) | 7/15 (46.7%) | 5/15 (33.3%) | ||||||
| Hypoglycemia | 0/3 (0%) | 2/3 (66.7%) | 0/4 (0%) | 2/3 (66.7%) | 6/15 (40%) | 4/15 (26.7%) | ||||||
| Hypokalemia | 0/3 (0%) | 1/3 (33.3%) | 2/4 (50%) | 0/3 (0%) | 3/15 (20%) | 8/15 (53.3%) | ||||||
| Hypomagnesemia | 1/3 (33.3%) | 1/3 (33.3%) | 0/4 (0%) | 1/3 (33.3%) | 2/15 (13.3%) | 6/15 (40%) | ||||||
| Hyponatremia | 1/3 (33.3%) | 1/3 (33.3%) | 3/4 (75%) | 3/3 (100%) | 5/15 (33.3%) | 6/15 (40%) | ||||||
| Hypophosphatemia | 2/3 (66.7%) | 1/3 (33.3%) | 1/4 (25%) | 1/3 (33.3%) | 3/15 (20%) | 6/15 (40%) | ||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Arthralgia | 2/3 (66.7%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 3/15 (20%) | 1/15 (6.7%) | ||||||
| Arthritis | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 2/15 (13.3%) | 0/15 (0%) | ||||||
| Back pain | 3/3 (100%) | 0/3 (0%) | 1/4 (25%) | 1/3 (33.3%) | 5/15 (33.3%) | 3/15 (20%) | ||||||
| Generalized muscle weakness | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 2/15 (13.3%) | 2/15 (13.3%) | ||||||
| Musculoskeletal and connective tissue disorder - Other, specify | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 1/15 (6.7%) | 2/15 (13.3%) | ||||||
| Myalgia | 2/3 (66.7%) | 2/3 (66.7%) | 1/4 (25%) | 0/3 (0%) | 4/15 (26.7%) | 2/15 (13.3%) | ||||||
| Pain in extremity | 2/3 (66.7%) | 0/3 (0%) | 3/4 (75%) | 1/3 (33.3%) | 2/15 (13.3%) | 2/15 (13.3%) | ||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | 1/3 (33.3%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/15 (0%) | 3/15 (20%) | ||||||
| Nervous system disorders | ||||||||||||
| Dizziness | 2/3 (66.7%) | 1/3 (33.3%) | 2/4 (50%) | 2/3 (66.7%) | 6/15 (40%) | 4/15 (26.7%) | ||||||
| Dysgeusia | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 2/15 (13.3%) | 1/15 (6.7%) | ||||||
| Headache | 2/3 (66.7%) | 2/3 (66.7%) | 2/4 (50%) | 1/3 (33.3%) | 4/15 (26.7%) | 6/15 (40%) | ||||||
| Memory impairment | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 1/3 (33.3%) | 1/15 (6.7%) | 2/15 (13.3%) | ||||||
| Nervous system disorders - Other, specify | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 2/15 (13.3%) | 0/15 (0%) | ||||||
| Paresthesia | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 1/15 (6.7%) | 1/15 (6.7%) | ||||||
| Peripheral sensory neuropathy | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 1/15 (6.7%) | 1/15 (6.7%) | ||||||
| Tremor | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 0/15 (0%) | 2/15 (13.3%) | ||||||
| Psychiatric disorders | ||||||||||||
| Anxiety | 1/3 (33.3%) | 0/3 (0%) | 1/4 (25%) | 1/3 (33.3%) | 0/15 (0%) | 3/15 (20%) | ||||||
| Confusion | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 2/15 (13.3%) | 4/15 (26.7%) | ||||||
| Insomnia | 2/3 (66.7%) | 0/3 (0%) | 1/4 (25%) | 1/3 (33.3%) | 3/15 (20%) | 4/15 (26.7%) | ||||||
| Renal and urinary disorders | ||||||||||||
| Urinary frequency | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 3/15 (20%) | 1/15 (6.7%) | ||||||
| Reproductive system and breast disorders | ||||||||||||
| Reproductive system and breast disorders - Other, specify | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/15 (0%) | 2/15 (13.3%) | ||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Cough | 1/3 (33.3%) | 1/3 (33.3%) | 2/4 (50%) | 1/3 (33.3%) | 7/15 (46.7%) | 3/15 (20%) | ||||||
| Dyspnea | 0/3 (0%) | 1/3 (33.3%) | 2/4 (50%) | 0/3 (0%) | 5/15 (33.3%) | 4/15 (26.7%) | ||||||
| Epistaxis | 1/3 (33.3%) | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 2/15 (13.3%) | 0/15 (0%) | ||||||
| Nasal congestion | 2/3 (66.7%) | 1/3 (33.3%) | 1/4 (25%) | 0/3 (0%) | 3/15 (20%) | 3/15 (20%) | ||||||
| Sore throat | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 1/15 (6.7%) | 1/15 (6.7%) | ||||||
| Skin and subcutaneous tissue disorders | ||||||||||||
| Alopecia | 1/3 (33.3%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Dry skin | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 1/15 (6.7%) | 2/15 (13.3%) | ||||||
| Hyperhidrosis | 3/3 (100%) | 0/3 (0%) | 2/4 (50%) | 1/3 (33.3%) | 3/15 (20%) | 1/15 (6.7%) | ||||||
| Nail loss | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 3/15 (20%) | 1/15 (6.7%) | ||||||
| Pruritus | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 2/15 (13.3%) | 2/15 (13.3%) | ||||||
| Rash acneiform | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 1/15 (6.7%) | 2/15 (13.3%) | ||||||
| Rash maculo-papular | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 6/15 (40%) | 3/15 (20%) | ||||||
| Skin/subcutaneous tissue disorders | 1/3 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 1/15 (6.7%) | 1/15 (6.7%) | ||||||
| Vascular disorders | ||||||||||||
| Hematoma | 1/3 (33.3%) | 1/3 (33.3%) | 1/4 (25%) | 0/3 (0%) | 4/15 (26.7%) | 0/15 (0%) | ||||||
| Hypertension | 0/3 (0%) | 0/3 (0%) | 2/4 (50%) | 1/3 (33.3%) | 3/15 (20%) | 5/15 (33.3%) | ||||||
| Hypotension | 0/3 (0%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 1/15 (6.7%) | 1/15 (6.7%) | ||||||
| Thromboembolic event | 1/3 (33.3%) | 0/3 (0%) | 1/4 (25%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Matthew Davids, MD, MMSc |
|---|---|
| Organization | Dana-Farber Cancer Institute |
| Phone | 617-632-6331 |
| matthew_davids@dfci.harvard.edu |
Responsible Party:
Matthew S. Davids, MD,
Principal Investigators,
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT02268851
Other Study ID Numbers:
- 14-396
- TGR-IB-105
First Posted:
Oct 20, 2014
Last Update Posted:
Oct 4, 2021
Last Verified:
Sep 1, 2021