Talimogene Laherparepvec in Combination With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer
Sponsor
H. Lee Moffitt Cancer Center and Research Institute (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02779855
Collaborator
Amgen (Industry)
50
1
1
76
0.7
Study Details
Study Description
Brief Summary
The purpose of this study is to determine if an oncolytic virus called Talimogene laherparepvec (a modified herpes simplex 1 virus that can specifically destroy cancer cells while leaving normal cells alone) injected directly into the tumor during chemotherapy prior to surgery can enhance the elimination of triple negative breast cancer tumors. The natural herpes simplex 1 virus typically causes cold sores around the mouth, but the talimogene laherparepvec version of the herpes virus has been changed to prevent it from reproducing in normal tissue.
However, it can still attack and break open cancer tissue which is why it is used as a treatment for cancer. It is thought that this virus can also help recruit the participant's immune system to attack the cancer cells during their treatment and possibly destroy the tumor tissue more effectively than chemotherapy alone. This virus is already FDA approved to treat melanoma skin tumors, so investigators want to determine if this virus can achieve a similar benefit in women with triple negative breast tumors.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2 Study of Talimogene Laherparepvec in Combination With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer
Actual Study Start Date
:
May 2, 2017
Actual Primary Completion Date
:
Sep 20, 2020
Anticipated Study Completion Date
:
Aug 31, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Talimogene laherparepvec + Chemotherapy Talimogene laherparepvec with Neoadjuvant Paclitaxel Chemotherapy treatment administration on an outpatient basis. Phase I: Dose Escalation to Determine Maximum Tolerated Dose (MTD). Phase II: Treatment at MTD. |
Biological: Talimogene laherparepvec
Talimogene laherparepvec injection. Phase I: Dose escalation. Phase II: Treatment at Maximum Tolerated Dose (MTD) from Phase I. The MTD dose level is defined as the highest dose level with ≤1 out of 6 patients experiencing a dose limiting toxicity (DLT).
Other Names:
Drug: Paclitaxel
Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m^2.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Phase I: Maximum Tolerated Dose (MTD) / Recommended Phase II Dose (RP2D) [Up to 6 months]
MTD/RP2D of talimogene laherparepvec administered with neoadjuvant paclitaxel- doxorubicin/cyclophosphamide chemotherapy.
- Phase II: Percentage of Participants With Pathologic Complete Response Rate (pCR) [Up to 36 months]
Perceptage of participants with pCR following study treatment, defined as: Disappearance of histopathologic evidence of malignant cells in breast and axillary lymph nodes.
Other Outcome Measures
- Recurrence Free Survival Rate [Up to 5 years follow-up]
Percentage of participants who are disease recurrence free at 5 year follow-up.
- Overall Survival (OS) Rate [Up to 5 years follow-up]
Percentage of participants who are alive at 5 year follow-up.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Must have histologically or cytologically confirmed clinical stage T2-3 N0-2 triple negative (estrogen receptor/progesterone receptor <1% human epidermal growth factor receptor 2 (HER2) 0-1 by ImmunoHistoChemistry (IHC) or unamplified by fluorescence in situ hybridization (FISH)) invasive ductal carcinoma.
-
Must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. As well, participants must have primary tumor able to be visualized on ultrasound and amenable to direct injection.
-
No prior history of an invasive breast cancer
-
Adults ages 18-70
-
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
-
Must have normal organ and marrow function as outlined in protocol
-
Sexually active women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
-
Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
-
T4 tumors, known metastatic disease, recurrent disease, inflammatory breast cancer, multicentric disease, and/or synchronous bilateral breast cancer
-
A second active malignancy, exceptions are localized non-melanoma skin cancers or prior in situ carcinoma
-
Receiving any other investigational agents or are unable to be treated with doxorubicin, cyclophosphamide, and paclitaxel.
-
History of allergic reactions attributed to compounds of similar chemical or biologic composition to talimogene laherparepvec or other agents used in the study
-
Known active or prior herpes simplex virus infections (HSV), prior complications from HSV infections such as encephalitis, or require systemic antiviral therapy at the time of study enrollment
-
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, known active hepatitis B/C infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
-
Women who are pregnant or nursing
-
Immunocompromised patients may be at increased risk of herpetic infections when treated with talimogene laherparepvec. Therefore, HIV-positive patients, patients with acquired or congenital immunodeficiency conditions, those on chronic systemic immunosuppressants (requiring > 10 mg of prednisone or equivalent/day), Those with active autoimmune disease are excluded from the study.
-
Have received any live vaccine therapies used for the prevention of infectious disease within 28 days prior to enrollment and during treatment period. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed. However, intranasal influenza vaccines (eg, Flu - Mist®) are live attenuated vaccines, and are not allowed.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | United States | 33612 |
Sponsors and Collaborators
- H. Lee Moffitt Cancer Center and Research Institute
- Amgen
Investigators
- Principal Investigator: Hatem Soliman, M.D., H. Lee Moffitt Cancer Center and Research Institute
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT02779855
Other Study ID Numbers:
- MCC-18621
First Posted:
May 20, 2016
Last Update Posted:
Jun 23, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Talimogene Laherparepvec + Chemotherapy -Phase 1 Dose Level 1 | Talimogene Laherparepvec + Chemotherapy -Phase 1 Dose Level 2 | Talimogene Laherparepvec + Chemotherapy -Phase 2 |
|---|---|---|---|
| Arm/Group Description | Talimogene laherparepvec with Neoadjuvant Paclitaxel Chemotherapy treatment administration on an outpatient basis. Phase I Dose Level 1: 10^6 PFU (plaque forming units) for all five injections Paclitaxel: Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m^2. | Talimogene laherparepvec with Neoadjuvant Paclitaxel Chemotherapy treatment administration on an outpatient basis. Phase I Dose Level 2: 10^6 PFU (plaque forming units) 1st injection, followed by 10^8 for remaining injections Paclitaxel: Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m^2. | Talimogene laherparepvec with Neoadjuvant Paclitaxel Chemotherapy treatment administration on an outpatient basis. Phase 2 at MTD Paclitaxel: Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m^2. |
| Period Title: Overall Study | |||
| STARTED | 4 | 6 | 40 |
| COMPLETED | 3 | 6 | 40 |
| NOT COMPLETED | 1 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Phase 1 Dose Level 1 | Phase 1 Dose Level 2 | Phase 2 | Total |
|---|---|---|---|---|
| Arm/Group Description | Talimogene laherparepvec with Neoadjuvant Paclitaxel Chemotherapy treatment administration on an outpatient basis. Phase I Dose Level 1: 10^6 PFU (plaque forming units) for all five injections Paclitaxel: Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m^2. | Talimogene laherparepvec with Neoadjuvant Paclitaxel Chemotherapy treatment administration on an outpatient basis. Phase I Dose Level 2: 10^6 PFU (plaque forming units) 1st injection, followed by 10^8 for remaining injections. Paclitaxel: Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m^2. | Phase II: Treatment at Maximum Tolerated Dose (MTD) from Phase I. The MTD dose level is defined as the highest dose level with ≤1 out of 6 patients experiencing a dose limiting toxicity (DLT). Talimogene laherparepvec: Talimogene laherparepvec injection. Phase II: treatment at MTD Paclitaxel: Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m^2. | Total of all reporting groups |
| Overall Participants | 3 | 6 | 40 | 49 |
| Age (Count of Participants) | ||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
3
100%
|
6
100%
|
38
95%
|
47
95.9%
|
| >=65 years |
0
0%
|
0
0%
|
2
5%
|
2
4.1%
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
3
100%
|
6
100%
|
40
100%
|
49
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
2
66.7%
|
2
33.3%
|
6
15%
|
10
20.4%
|
| Not Hispanic or Latino |
1
33.3%
|
4
66.7%
|
33
82.5%
|
38
77.6%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
1
2.5%
|
1
2%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
1
2.5%
|
1
2%
|
| Asian |
0
0%
|
0
0%
|
5
12.5%
|
5
10.2%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
2
33.3%
|
4
10%
|
6
12.2%
|
| White |
2
66.7%
|
3
50%
|
27
67.5%
|
32
65.3%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
1
33.3%
|
1
16.7%
|
3
7.5%
|
5
10.2%
|
| Region of Enrollment (participants) [Number] | ||||
| United States |
3
100%
|
6
100%
|
40
100%
|
49
100%
|
Outcome Measures
| Title | Phase I: Maximum Tolerated Dose (MTD) / Recommended Phase II Dose (RP2D) |
|---|---|
| Description | MTD/RP2D of talimogene laherparepvec administered with neoadjuvant paclitaxel- doxorubicin/cyclophosphamide chemotherapy. |
| Time Frame | Up to 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Talimogene Laherparepvec + Chemotherapy |
|---|---|
| Arm/Group Description | Talimogene laherparepvec with Neoadjuvant Paclitaxel Chemotherapy treatment administration on an outpatient basis. Phase I: Dose Escalation to Determine Maximum Tolerated Dose (MTD). Phase II: Treatment at MTD. Talimogene laherparepvec: Talimogene laherparepvec injection. Phase I: Dose escalation. Phase II: Treatment at Maximum Tolerated Dose (MTD) from Phase I. The MTD dose level is defined as the highest dose level with ≤1 out of 6 patients experiencing a dose limiting toxicity (DLT). Paclitaxel: Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m^2. |
| Measure Participants | 9 |
| Number [million plaque forming units per mL] |
100
|
| Title | Phase II: Percentage of Participants With Pathologic Complete Response Rate (pCR) |
|---|---|
| Description | Perceptage of participants with pCR following study treatment, defined as: Disappearance of histopathologic evidence of malignant cells in breast and axillary lymph nodes. |
| Time Frame | Up to 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients evaluable for response per protocol |
| Arm/Group Title | Phase 1 Dose Level 1 | Phase 1 Dose Level 2 | Phase 2 |
|---|---|---|---|
| Arm/Group Description | Talimogene laherparepvec with Neoadjuvant Paclitaxel Chemotherapy treatment administration on an outpatient basis. Phase I Dose Level 1: 10^6 PFU (plaque forming units) for all five injections Paclitaxel: Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m^2. | Talimogene laherparepvec with Neoadjuvant Paclitaxel Chemotherapy treatment administration on an outpatient basis. Phase I Dose Level 2: 10^6 PFU (plaque forming units) 1st injection, followed by 10^8 PFU for remaining injections. Paclitaxel: Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m^2. | Phase II: Treatment at Maximum Tolerated Dose (MTD) from Phase I. The MTD dose level is defined as the highest dose level with ≤1 out of 6 patients experiencing a dose limiting toxicity (DLT). Talimogene laherparepvec: Talimogene laherparepvec injection. Phase II: treatment at MTD Paclitaxel: Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m^2. |
| Measure Participants | 3 | 6 | 37 |
| Number [percentage of participants] |
66.7
2223.3%
|
50
833.3%
|
43.24
108.1%
|
| Title | Recurrence Free Survival Rate |
|---|---|
| Description | Percentage of participants who are disease recurrence free at 5 year follow-up. |
| Time Frame | Up to 5 years follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Overall Survival (OS) Rate |
|---|---|
| Description | Percentage of participants who are alive at 5 year follow-up. |
| Time Frame | Up to 5 years follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | Adverse events collected from on study date to 30 days post last study treatment (3 years, 4.5 months) | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Phase 1 Dose Level 1 | Phase 1 Dose Level 2 | Phase 2 | |||
| Arm/Group Description | .Talimogene laherparepvec with Neoadjuvant Paclitaxel Chemotherapy treatment administration on an outpatient basis. Phase I Dose Level 1: 10^6 PFU (plaque forming units) for all five injections Paclitaxel: Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m^2. | .Talimogene laherparepvec with Neoadjuvant Paclitaxel Chemotherapy treatment administration on an outpatient basis. Phase I Dose Level 1: 10^6 PFU (plaque forming units) 1st injection, followed by 10^8 PFU for remaining injections. Paclitaxel: Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m^2. | Phase II: Treatment at Maximum Tolerated Dose (MTD) . The MTD dose level is defined as the highest dose level with ≤1 out of 6 patients experiencing a dose limiting toxicity (DLT). Talimogene laherparepvec: Talimogene laherparepvec injection. Phase II: treatment at MTD Paclitaxel: Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m^2. | |||
All Cause Mortality |
||||||
| Phase 1 Dose Level 1 | Phase 1 Dose Level 2 | Phase 2 | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/3 (0%) | 4/6 (66.7%) | 1/40 (2.5%) | |||
Serious Adverse Events |
||||||
| Phase 1 Dose Level 1 | Phase 1 Dose Level 2 | Phase 2 | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/3 (33.3%) | 4/6 (66.7%) | 7/40 (17.5%) | |||
| Blood and lymphatic system disorders | ||||||
| Febrile neuropenia | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/40 (0%) | 0 |
| Cardiac disorders | ||||||
| Cardiac arrest | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/40 (0%) | 0 |
| General disorders | ||||||
| Fever | 0/3 (0%) | 0 | 2/6 (33.3%) | 3 | 0/40 (0%) | 0 |
| Pain | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Edema limbs | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Infections and infestations | ||||||
| Periorbital infection | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Lung infection | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 2/40 (5%) | 2 |
| Skin infection | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||
| Myositis | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Nervous system disorders | ||||||
| Headache | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Syncope | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Peripheral motor neuropathy | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Vascular disorders | ||||||
| Thromboembolic event | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 1 | 3/40 (7.5%) | 3 |
| Superficial thrombophlebitis | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||
| Phase 1 Dose Level 1 | Phase 1 Dose Level 2 | Phase 2 | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/3 (100%) | 6/6 (100%) | 39/40 (97.5%) | |||
| Blood and lymphatic system disorders | ||||||
| Anemia | 3/3 (100%) | 16 | 6/6 (100%) | 26 | 35/40 (87.5%) | 102 |
| Leukocystosis | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 6/40 (15%) | 7 |
| Febrile neuropenia | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 1/40 (2.5%) | 1 |
| Blood and lymphatic system disorders -Other | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Cardiac disorders | ||||||
| Sinus tachycardia | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 4/40 (10%) | 6 |
| Palpitations | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 3/40 (7.5%) | 4 |
| Sinus bradycardia | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 1/40 (2.5%) | 1 |
| Cardiac arrest | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/40 (0%) | 0 |
| Cardiac disorders - Other | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Ear and labyrinth disorders | ||||||
| Ear pain | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 2/40 (5%) | 3 |
| Tinnitus | 0/3 (0%) | 0 | 2/6 (33.3%) | 3 | 0/40 (0%) | 0 |
| Vertigo | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Endocrine disorders | ||||||
| Hyperparathyroidism | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Eye disorders | ||||||
| Blurred vision | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 7/40 (17.5%) | 9 |
| Dry eye | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 6/40 (15%) | 6 |
| Eye disorders - Other | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 4/40 (10%) | 6 |
| Watering eyes | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 4/40 (10%) | 5 |
| Conjunctivitis | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 2/40 (5%) | 2 |
| Eye pain | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Floaters | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Papilledema | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/40 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Nausea | 2/3 (66.7%) | 4 | 6/6 (100%) | 12 | 29/40 (72.5%) | 51 |
| Diarrhea | 1/3 (33.3%) | 1 | 3/6 (50%) | 4 | 16/40 (40%) | 29 |
| Constipation | 2/3 (66.7%) | 2 | 1/6 (16.7%) | 1 | 15/40 (37.5%) | 18 |
| Mucositis oral | 1/3 (33.3%) | 1 | 3/6 (50%) | 3 | 14/40 (35%) | 17 |
| Gastroesophageal reflux disease | 2/3 (66.7%) | 2 | 3/6 (50%) | 5 | 9/40 (22.5%) | 10 |
| Vomitting | 1/3 (33.3%) | 1 | 4/6 (66.7%) | 6 | 9/40 (22.5%) | 13 |
| Abdominal pain | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 1 | 11/40 (27.5%) | 19 |
| Oral pain | 0/3 (0%) | 0 | 1/6 (16.7%) | 2 | 11/40 (27.5%) | 12 |
| Gastritis | 0/3 (0%) | 0 | 2/6 (33.3%) | 3 | 4/40 (10%) | 6 |
| Dry mouth | 0/3 (0%) | 0 | 2/6 (33.3%) | 2 | 3/40 (7.5%) | 3 |
| Dyspepsia | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 2/40 (5%) | 2 |
| Bloating | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 1/40 (2.5%) | 1 |
| Flatulence | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 1/40 (2.5%) | 1 |
| Gastrointestinal disorders - Other | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 2/40 (5%) | 2 |
| Hemorrhoids | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 1/40 (2.5%) | 1 |
| Cheilitis | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Dysphagia | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Lower gastrointestinal hemorrhage | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| General disorders | ||||||
| Fatigue | 1/3 (33.3%) | 2 | 4/6 (66.7%) | 9 | 34/40 (85%) | 59 |
| Fever | 3/3 (100%) | 4 | 5/6 (83.3%) | 6 | 18/40 (45%) | 37 |
| Chills | 0/3 (0%) | 0 | 3/6 (50%) | 4 | 21/40 (52.5%) | 37 |
| Flu like symptoms | 2/3 (66.7%) | 2 | 3/6 (50%) | 3 | 10/40 (25%) | 15 |
| Injection site reaction | 1/3 (33.3%) | 3 | 3/6 (50%) | 4 | 10/40 (25%) | 15 |
| Infusion related reaction | 2/3 (66.7%) | 4 | 4/6 (66.7%) | 5 | 7/40 (17.5%) | 13 |
| Pain | 0/3 (0%) | 0 | 2/6 (33.3%) | 2 | 10/40 (25%) | 11 |
| Edema limbs | 1/3 (33.3%) | 1 | 2/6 (33.3%) | 3 | 9/40 (22.5%) | 13 |
| Non-cardiac chest pain | 0/3 (0%) | 0 | 4/6 (66.7%) | 4 | 4/40 (10%) | 5 |
| Edema face | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 3/40 (7.5%) | 3 |
| Malaise | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 2/40 (5%) | 2 |
| General disorders and administration site conditions - Other | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Localized edema | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 2/40 (5%) | 2 |
| Gait disturbance | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Neck edema | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Immune system disorders | ||||||
| Allergic reaction | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 1 | 5/40 (12.5%) | 5 |
| Infections and infestations | ||||||
| Upper respiratory infection | 0/3 (0%) | 0 | 4/6 (66.7%) | 5 | 13/40 (32.5%) | 16 |
| Skin infection | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 10/40 (25%) | 15 |
| Sinusitis | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 5/40 (12.5%) | 5 |
| Urinary tract infection | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 6/40 (15%) | 12 |
| Vaginal infection | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 1 | 4/40 (10%) | 4 |
| Lip infection | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 5/40 (12.5%) | 5 |
| Paronychia | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 4/40 (10%) | 6 |
| Lung infection | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 2/40 (5%) | 2 |
| Papulopustular rash | 0/3 (0%) | 0 | 2/6 (33.3%) | 2 | 0/40 (0%) | 0 |
| Infections and infestations - Other | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Mucosal infection | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Nail infection | 0/3 (0%) | 0 | 1/6 (16.7%) | 2 | 0/40 (0%) | 0 |
| Periorbital infection | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Pharyngitis | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/40 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| Bruising | 1/3 (33.3%) | 1 | 2/6 (33.3%) | 3 | 3/40 (7.5%) | 3 |
| Burn | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Investigations | ||||||
| White blood cell decreased | 1/3 (33.3%) | 5 | 5/6 (83.3%) | 11 | 19/40 (47.5%) | 43 |
| Alanine aminotransferase increased | 1/3 (33.3%) | 2 | 4/6 (66.7%) | 7 | 17/40 (42.5%) | 26 |
| Neutrophil count decreased | 1/3 (33.3%) | 3 | 5/6 (83.3%) | 10 | 16/40 (40%) | 51 |
| Alkaline phosphatase increased | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 13/40 (32.5%) | 15 |
| Platelet count decreased | 1/3 (33.3%) | 1 | 2/6 (33.3%) | 2 | 7/40 (17.5%) | 10 |
| Aspartate aminotransferase increased | 0/3 (0%) | 0 | 2/6 (33.3%) | 4 | 6/40 (15%) | 6 |
| Weight gain | 0/3 (0%) | 0 | 1/6 (16.7%) | 2 | 4/40 (10%) | 4 |
| Weight loss | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 5/40 (12.5%) | 6 |
| Creatinine increased | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 1/40 (2.5%) | 2 |
| Lymphocyte count decreased | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 2/40 (5%) | 3 |
| Ejection fraction decreased | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Electrocardiogram QT corrected interval prolonged | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/40 (0%) | 0 |
| Hemoglobin increased | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Lymphocyte count increased | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Metabolism and nutrition disorders | ||||||
| Hyperkalemia | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 13/40 (32.5%) | 18 |
| Anorexia | 0/3 (0%) | 0 | 2/6 (33.3%) | 4 | 10/40 (25%) | 11 |
| Hypocalcemia | 1/3 (33.3%) | 1 | 2/6 (33.3%) | 4 | 3/40 (7.5%) | 3 |
| Dehydration | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 4/40 (10%) | 5 |
| Hypernatremia | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 5/40 (12.5%) | 5 |
| Hypoalbuminemia | 1/3 (33.3%) | 2 | 2/6 (33.3%) | 2 | 2/40 (5%) | 2 |
| Hypokalemia | 0/3 (0%) | 0 | 2/6 (33.3%) | 2 | 3/40 (7.5%) | 4 |
| Hyperglycemia | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 4/40 (10%) | 5 |
| Hypercalcemia | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 2/40 (5%) | 4 |
| Hypophosphatemia | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 1/40 (2.5%) | 4 |
| Hypermagnesemia | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 3 |
| Hypomagnesemia | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/40 (0%) | 0 |
| Hyponatremia | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Metabolism and nutrition disorders - Other | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Obesity | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/40 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Myalgia | 2/3 (66.7%) | 2 | 1/6 (16.7%) | 2 | 12/40 (30%) | 17 |
| Arthralgia | 1/3 (33.3%) | 1 | 3/6 (50%) | 3 | 10/40 (25%) | 10 |
| Bone pain | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 12/40 (30%) | 19 |
| Generalized muscle weakness | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 8/40 (20%) | 10 |
| Back pain | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 5/40 (12.5%) | 7 |
| Neck pain | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 3/40 (7.5%) | 3 |
| Pain in extremity | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 3/40 (7.5%) | 3 |
| Chest wall pain | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 2/40 (5%) | 2 |
| Muscle weakness lower limb | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 2/40 (5%) | 4 |
| Flank pain | 0/3 (0%) | 0 | 1/6 (16.7%) | 2 | 0/40 (0%) | 0 |
| Myositis | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Nervous system disorders | ||||||
| Peripheral sensory neuropathy | 2/3 (66.7%) | 2 | 3/6 (50%) | 8 | 25/40 (62.5%) | 38 |
| Headache | 2/3 (66.7%) | 3 | 2/6 (33.3%) | 4 | 20/40 (50%) | 33 |
| Dizziness | 2/3 (66.7%) | 2 | 1/6 (16.7%) | 1 | 11/40 (27.5%) | 15 |
| Dysgeusia | 0/3 (0%) | 0 | 2/6 (33.3%) | 2 | 12/40 (30%) | 14 |
| Cognitive disturbance | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 4/40 (10%) | 4 |
| Paresthesia | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 3/40 (7.5%) | 3 |
| Nervous system disorders - Other | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 1/40 (2.5%) | 1 |
| Syncope | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 1/40 (2.5%) | 2 |
| Amnesia | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Memory impairment | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Peripheral motor neuropathy | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Psychiatric disorders | ||||||
| Anxiety | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 7/40 (17.5%) | 9 |
| Insomnia | 1/3 (33.3%) | 1 | 2/6 (33.3%) | 2 | 4/40 (10%) | 6 |
| Depression | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 4/40 (10%) | 4 |
| Confusion | 0/3 (0%) | 0 | 1/6 (16.7%) | 2 | 0/40 (0%) | 0 |
| Restlessness | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Renal and urinary disorders | ||||||
| Urinary frequency | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 4/40 (10%) | 4 |
| Cystitis noninfective | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Urinary tract pain | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Urinary urgency | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Urine discoloration | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Reproductive system and breast disorders | ||||||
| Breast pain | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 9/40 (22.5%) | 14 |
| Irregular menstruation | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 2/40 (5%) | 2 |
| Menorrhagia | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 1 | 0/40 (0%) | 0 |
| Vaginal discharge | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 2/40 (5%) | 2 |
| Pelvic pain | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 2 |
| Vaginal pain | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 2 |
| Vascular access complication | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 4/40 (10%) | 4 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 0/3 (0%) | 0 | 3/6 (50%) | 4 | 15/40 (37.5%) | 16 |
| Dyspnea | 1/3 (33.3%) | 1 | 3/6 (50%) | 3 | 9/40 (22.5%) | 12 |
| Nasal congestion | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 10/40 (25%) | 10 |
| Epistaxis | 2/3 (66.7%) | 2 | 2/6 (33.3%) | 2 | 4/40 (10%) | 4 |
| Allergic rhinitis | 0/3 (0%) | 0 | 4/6 (66.7%) | 4 | 3/40 (7.5%) | 3 |
| Sore throat | 0/3 (0%) | 0 | 1/6 (16.7%) | 2 | 6/40 (15%) | 6 |
| Postnasal drip | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 4/40 (10%) | 5 |
| Hoarseness | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 2/40 (5%) | 2 |
| Hypoxia | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Productive cough | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Pulmonary edema | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Wheezing | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 2 |
| Skin and subcutaneous tissue disorders | ||||||
| Rash maculo-papular | 2/3 (66.7%) | 2 | 3/6 (50%) | 3 | 18/40 (45%) | 23 |
| Alopecia | 1/3 (33.3%) | 1 | 4/6 (66.7%) | 4 | 14/40 (35%) | 14 |
| Pruritus | 1/3 (33.3%) | 1 | 3/6 (50%) | 5 | 13/40 (32.5%) | 14 |
| Nail discoloration | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 1 | 6/40 (15%) | 7 |
| Dry skin | 0/3 (0%) | 0 | 2/6 (33.3%) | 3 | 5/40 (12.5%) | 5 |
| Skin and subcutaneous tissue disorders - Other | 0/3 (0%) | 0 | 2/6 (33.3%) | 2 | 5/40 (12.5%) | 6 |
| Rash acneiform | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 6/40 (15%) | 6 |
| Scalp pain | 0/3 (0%) | 0 | 2/6 (33.3%) | 2 | 4/40 (10%) | 4 |
| Skin hyperpigmentation | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 5/40 (12.5%) | 5 |
| Nail ridging | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 1 | 2/40 (5%) | 2 |
| Nail loss | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 2/40 (5%) | 2 |
| Skin ulceration | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 3/40 (7.5%) | 3 |
| Bullous dermatitis | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 2/40 (5%) | 2 |
| Pain of skin | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 2/40 (5%) | 2 |
| Periorbital edema | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Photosensitivity | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/40 (0%) | 0 |
| Skin hypopigmentation | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Telangiectasia | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
| Urticaria | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/40 (0%) | 0 |
| Social circumstances | ||||||
| Menopause | 2/3 (66.7%) | 2 | 0/6 (0%) | 0 | 0/40 (0%) | 0 |
| Vascular disorders | ||||||
| Hot flashes | 1/3 (33.3%) | 1 | 2/6 (33.3%) | 2 | 6/40 (15%) | 6 |
| Hypertension | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 7/40 (17.5%) | 10 |
| Hematoma | 1/3 (33.3%) | 1 | 2/6 (33.3%) | 3 | 3/40 (7.5%) | 3 |
| Thromboembolic event | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 1 | 4/40 (10%) | 5 |
| Flushing | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 2/40 (5%) | 2 |
| Hypotension | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 2/40 (5%) | 2 |
| Capillary leak syndrome | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/40 (2.5%) | 1 |
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 | Hatem Soliman, MD |
|---|---|
| Organization | Moffitt Cancer Center |
| Phone | 813-745-4985 |
| hatem.soliman@moffitt.org |
Responsible Party:
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT02779855
Other Study ID Numbers:
- MCC-18621
First Posted:
May 20, 2016
Last Update Posted:
Jun 23, 2022
Last Verified:
Jun 1, 2022