Lonafarnib in Metastatic Breast Cancer
Study Details
Study Description
Brief Summary
A published phase 2 study reported that lonafarnib was administered as a single agent via continuous or intermittent oral dosing to 76 women with advanced breast cancer who were previously treated with chemotherapy and/or with endocrine therapy. Objective response rates of approximately 10% were observed. This study will determine the rate of progression-free survival of patients with metastatic breast cancer who receive lonafarnib.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
OUTLINE: This is a multi-center study
Patients will be treated with lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
1 Cycle = 21 days of lonafarnib (plus the time required to recover from toxicity if encountered).
ECOG Performance Status 0-1
Life Expectancy: Not Specified
Hematopoietic:
-
Platelets > 100 K/mm3
-
Absolute Neutrophil Count (ANC) > 1.2 K/mm3
-
Hemoglobin ≥ 9 g/dl
-
Serum potassium ≥ 3.3 mmol/L
Hepatic:
-
Aspartate transaminase (AST) ≤ 5.0 x ULN
-
Alanine transaminase (ALT) ≤ 5.0 x ULN
-
Total bilirubin < 1.5 x ULN
Renal:
- Calculated creatinine clearance (using Cockcroft-Gault formula) > 45 cc/min
Cardiovascular:
- No history of Torsades de Pointes, ventricular tachycardia, ventricular fibrillation or ventricular flutter
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lonafarnib All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion. |
Drug: Lonafarnib
All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
|
Outcome Measures
Primary Outcome Measures
- Progression Free Survival [18 months]
To determine progression-free survival of lonafarnib in patients with metastatic breast cancer.
Secondary Outcome Measures
- Overall Response Rate [18 months]
To determine overall response rate.
- Toxicity Profile of Lonafarib [18 months]
To determine the toxicity profile of lonafarnib in this patient population.
- Clinical Benefit Response Rate (Complete Response (CR)+Partial Response(PR)+Stable Disease(SD) > 180 Day Duration). [18 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histological or cytological confirmed adenocarcinoma of the breast with locally advanced or metastatic disease.
-
Must be able and willing to enroll in the companion study entitled "Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study: Hoosier Oncology Group COE-03."
-
Must have measurable disease per RECIST as evaluated by imaging within 28 days prior to registration for protocol therapy.
-
Must be willing to not drink grapefruit juice for the duration of lonafarnib therapy.
-
Previously radiated area(s) must not be the only site of disease for study entry.
-
Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time of consent until at least 90 days following completion of study treatment.
-
Females of childbearing potential must have a negative pregnancy test within 7 days prior to registration for protocol therapy. Subjects are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
-
Females must not be breastfeeding.
-
Written informed consent and HIPAA authorization for release of personal health information.
-
Age > 18 years
Exclusion Criteria:
-
No history or radiologic evidence of CNS metastases including previously treated, resected or asymptomatic brain lesions or leptomeningeal involvement (head CT or MRI must be obtained within 42 days prior to registration for protocol therapy).
-
No treatment with any investigational agent within 30 days prior to registration for protocol therapy.
-
No history of Torsades de Pointes, ventricular tachycardia, ventricular fibrillation or ventricular flutter.
-
No history of syncope.
-
No history of seizures.
-
No prolonged QTc interval > 450msec on pre-entry electrocardiogram obtained within 28 days prior to registration for protocol therapy.
-
No history of hypokalemia that cannot be corrected prior to registration for protocol therapy.
-
No radiation within 14 days prior to registration for protocol therapy. Patients must have recovered from the acute toxic effects prior to registration for protocol therapy.
-
No prior chemotherapy within 21 days prior to registration for protocol therapy.
-
No clinically active serious infections as judged by the treating investigator (CTC v3, > Grade 2) including known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
-
Following concomitant medications must be discontinued 7 days prior to registration for protocol therapy and for the duration of lonafarnib therapy: bisphosphonates, including but not limited to etidronate (Didronel), pamidronate (Aredia), alendronate (Fosamax), risedronate (Actonel), zoledronate (Zometa or Reclast), ibandronate (Boniva), ethinylestradiol, gestodene, itraconazole, ketoconazole, cimetidine, erythromycin, carbamazepine, high dose chronic steroids, phenobarbital, phenytoin, rifampin (rifampicin), sulfinpyrazone
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical & Surgical Specialists, LLC | Galesburg | Illinois | United States | 61401 |
| 2 | Cancer Care Center of Southern Indiana | Bloomington | Indiana | United States | 47403 |
| 3 | Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | United States | 46202 |
| 4 | Arnett Cancer Care | Lafayette | Indiana | United States | 47904 |
| 5 | Horizon Oncology Center | Lafayette | Indiana | United States | 47905 |
| 6 | Ireland Cancer Center - University Hospitals of Cleveland | Cleveland | Ohio | United States | 44106 |
Sponsors and Collaborators
- George Sledge
- Schering-Plough
- Hoosier Cancer Research Network
Investigators
- Principal Investigator: George Sledge, M.D., Hoosier Cancer Research Network
- Principal Investigator: Brian Leland-Jones, M.D., Hoosier Cancer Research Network
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- HOG BRE07-126
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Lonafarnib |
|---|---|
| Arm/Group Description | All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion. Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion. |
| Period Title: Overall Study | |
| STARTED | 29 |
| COMPLETED | 29 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Lonafarnib |
|---|---|
| Arm/Group Description | All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion. Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion. |
| Overall Participants | 29 |
| Age (years) [Median (Full Range) ] | |
| Median (Full Range) [years] |
56
|
| Sex: Female, Male (Count of Participants) | |
| Female |
29
100%
|
| Male |
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
1
3.4%
|
| Not Hispanic or Latino |
27
93.1%
|
| Unknown or Not Reported |
1
3.4%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
3
10.3%
|
| White |
26
89.7%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
29
100%
|
| Primary Tumor Diagnosis (participants) [Number] | |
| Breast Carcinoma |
14
48.3%
|
| Ductal Breast Carcinoma |
20
69%
|
| Lobular Breast Carcinoma |
1
3.4%
|
| Other |
1
3.4%
|
| Estrogen Receptor (ER)/Progesterone Receptor (PR)/ HER2 Status (participants) [Number] | |
| ER- |
9
31%
|
| ER+ |
15
51.7%
|
| PR- |
13
44.8%
|
| PR+ |
11
37.9%
|
| HER2- |
17
58.6%
|
| HER2+ |
3
10.3%
|
| Unknown |
4
13.8%
|
| Number of Prior Therapies (Prior Therapies) [Median (Full Range) ] | |
| Median (Full Range) [Prior Therapies] |
8.4
|
Outcome Measures
| Title | Progression Free Survival |
|---|---|
| Description | To determine progression-free survival of lonafarnib in patients with metastatic breast cancer. |
| Time Frame | 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 20 participants were eligible for analysis via the Kaplan-Meier method. PFS assessed via RECIST criteria. |
| Arm/Group Title | Lonafarnib |
|---|---|
| Arm/Group Description | All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion. Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion. |
| Measure Participants | 20 |
| Mean (95% Confidence Interval) [days] |
65.5
|
| Title | Overall Response Rate |
|---|---|
| Description | To determine overall response rate. |
| Time Frame | 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 17 participants were evaluable for Overall Response Rate analysis using RECIST criteria. |
| Arm/Group Title | Lonafarnib |
|---|---|
| Arm/Group Description | All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion. Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion. |
| Measure Participants | 17 |
| CR |
0
0%
|
| PR |
0
0%
|
| SD |
5
17.2%
|
| PD |
12
41.4%
|
| Title | Toxicity Profile of Lonafarib |
|---|---|
| Description | To determine the toxicity profile of lonafarnib in this patient population. |
| Time Frame | 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Lonafarnib |
|---|---|
| Arm/Group Description | All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion. Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion. |
| Measure Participants | 29 |
| Grade 3/4 Diarrhea |
6
20.7%
|
| Grade 3/4 Dehydration |
2
6.9%
|
| Grade 5 Encephalopathy |
1
3.4%
|
| Disease Progression NOS |
1
3.4%
|
| Title | Clinical Benefit Response Rate (Complete Response (CR)+Partial Response(PR)+Stable Disease(SD) > 180 Day Duration). |
|---|---|
| Description | |
| Time Frame | 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 20 evaluable subjects were analyzed for Clinical Benefit Rate (CR+PR+SD>180 days per RECIST criteria. |
| Arm/Group Title | Lonafarnib |
|---|---|
| Arm/Group Description | All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion. Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion. |
| Measure Participants | 20 |
| Number [participants] |
0
0%
|
Adverse Events
| Time Frame | Duration of Study, a maximum of seven cycles (Typically 21 days) | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Lonafarnib | |
| Arm/Group Description | All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion. Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion. | |
All Cause Mortality |
||
| Lonafarnib | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Lonafarnib | ||
| Affected / at Risk (%) | # Events | |
| Total | 7/29 (24.1%) | |
| Gastrointestinal disorders | ||
| DEHYDRATION | 1/29 (3.4%) | 2 |
| General disorders | ||
| DEATH NOT ASSOCIATED WITH CTCAE TERM / DISEASE PROGRESSION NOS | 1/29 (3.4%) | 1 |
| Hepatobiliary disorders | ||
| HEPATOBILIARY/PANCREAS - OTHER | 1/29 (3.4%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| FRACTURE | 1/29 (3.4%) | 1 |
| MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / WHOLE BODY/GENERALIZED | 1/29 (3.4%) | 1 |
| Nervous system disorders | ||
| ATAXIA (INCOORDINATION) | 1/29 (3.4%) | 1 |
| ENCEPHALOPATHY | 1/29 (3.4%) | 2 |
| Psychiatric disorders | ||
| MOOD ALTERATION / ANXIETY | 1/29 (3.4%) | 1 |
| SOMNOLENCE/DEPRESSED LEVEL OF CONSCIOUSNESS | 1/29 (3.4%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| PNEUMONITIS/PULMONARY INFILTRATES | 1/29 (3.4%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Lonafarnib | ||
| Affected / at Risk (%) | # Events | |
| Total | 29/29 (100%) | |
| Blood and lymphatic system disorders | ||
| BLOOD/BONE MARROW - OTHER | 1/29 (3.4%) | 1 |
| DERMAL CHANGE LYMPHEDEMA, PHLEBOLYMPHEDEMA | 2/29 (6.9%) | 2 |
| EDEMA: LIMB | 2/29 (6.9%) | 2 |
| HEMOGLOBIN | 8/29 (27.6%) | 10 |
| LEUKOCYTES (TOTAL WBC) | 2/29 (6.9%) | 3 |
| LYMPHOPENIA | 3/29 (10.3%) | 5 |
| NEUTROPHILS/GRANULOCYTES (ANC/AGC) | 1/29 (3.4%) | 1 |
| PLATELETS | 4/29 (13.8%) | 4 |
| Cardiac disorders | ||
| CARDIAC ARRHYTHMIA - OTHER | 2/29 (6.9%) | 2 |
| CARDIAC GENERAL - OTHER | 1/29 (3.4%) | 1 |
| HYPERTENSION | 3/29 (10.3%) | 3 |
| PROLONGED QTC INTERVAL | 1/29 (3.4%) | 2 |
| Ear and labyrinth disorders | ||
| TINNITUS | 1/29 (3.4%) | 1 |
| Endocrine disorders | ||
| HOT FLASHES/FLUSHES | 9/29 (31%) | 9 |
| PANCREATIC ENDOCRINE: GLUCOSE INTOLERANCE | 1/29 (3.4%) | 1 |
| THYROID FUNCTION, LOW (HYPOTHYROIDISM) | 2/29 (6.9%) | 2 |
| Eye disorders | ||
| DRY EYE SYNDROME | 2/29 (6.9%) | 2 |
| EYELID DYSFUNCTION | 1/29 (3.4%) | 1 |
| OCULAR/VISUAL - OTHER | 1/29 (3.4%) | 1 |
| VISION-BLURRED VISION | 1/29 (3.4%) | 1 |
| Gastrointestinal disorders | ||
| ANOREXIA | 17/29 (58.6%) | 27 |
| COLITIS, INFECTIOUS (E.G., CLOSTRIDIUM DIFFICILE) | 1/29 (3.4%) | 1 |
| CONSTIPATION | 15/29 (51.7%) | 17 |
| DEHYDRATION | 3/29 (10.3%) | 3 |
| DIARRHEA | 22/29 (75.9%) | 57 |
| DISTENSION/BLOATING, ABDOMINAL | 1/29 (3.4%) | 1 |
| DRY MOUTH/SALIVARY GLAND (XEROSTOMIA) | 1/29 (3.4%) | 1 |
| FLATULENCE | 2/29 (6.9%) | 2 |
| GASTROINTESTINAL - OTHER | 2/29 (6.9%) | 3 |
| HEARTBURN/DYSPEPSIA | 6/29 (20.7%) | 7 |
| INCONTINENCE, ANAL | 1/29 (3.4%) | 2 |
| MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / STOMACH | 1/29 (3.4%) | 1 |
| NAUSEA | 18/29 (62.1%) | 36 |
| PAIN / ABDOMEN NOS | 5/29 (17.2%) | 6 |
| PAIN / STOMACH | 1/29 (3.4%) | 1 |
| TASTE ALTERATION (DYSGEUSIA) | 10/29 (34.5%) | 12 |
| VOMITING | 13/29 (44.8%) | 20 |
| General disorders | ||
| FATIGUE (ASTHENIA, LETHARGY, MALAISE) | 25/29 (86.2%) | 48 |
| FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L) | 1/29 (3.4%) | 2 |
| FLU-LIKE SYNDROME | 1/29 (3.4%) | 1 |
| GROWTH AND DEVELOPMENT - OTHER | 1/29 (3.4%) | 1 |
| INSOMNIA | 15/29 (51.7%) | 18 |
| OBESITY | 1/29 (3.4%) | 1 |
| PAIN / BACK | 8/29 (27.6%) | 9 |
| PAIN / HEAD/HEADACHE | 6/29 (20.7%) | 7 |
| PAIN / NECK | 1/29 (3.4%) | 1 |
| PAIN / PAIN NOS | 3/29 (10.3%) | 5 |
| PAIN / PELVIS | 3/29 (10.3%) | 4 |
| PAIN / TUMOR PAIN | 1/29 (3.4%) | 1 |
| PAIN - OTHER | 1/29 (3.4%) | 1 |
| RIGORS/CHILLS | 1/29 (3.4%) | 1 |
| SWEATING (DIAPHORESIS) | 1/29 (3.4%) | 1 |
| WEIGHT GAIN | 1/29 (3.4%) | 1 |
| WEIGHT LOSS | 3/29 (10.3%) | 5 |
| Immune system disorders | ||
| ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP) | 1/29 (3.4%) | 1 |
| ALLERGY/IMMUNOLOGY - OTHER | 2/29 (6.9%) | 2 |
| Infections and infestations | ||
| INFECTIONWITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / SINUS | 1/29 (3.4%) | 1 |
| INFECTION - OTHER | 2/29 (6.9%) | 2 |
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / URINARY TRACT NOS | 1/29 (3.4%) | 1 |
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / WOUND | 1/29 (3.4%) | 1 |
| Investigations | ||
| ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA) | 5/29 (17.2%) | 7 |
| ALKALINE PHOSPHATASE | 5/29 (17.2%) | 6 |
| ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE) | 3/29 (10.3%) | 4 |
| AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE) | 8/29 (27.6%) | 12 |
| BILIRUBIN (HYPERBILIRUBINEMIA) | 1/29 (3.4%) | 1 |
| CALCIUM, SERUM-HIGH (HYPERCALCEMIA) | 1/29 (3.4%) | 1 |
| CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTREMIA) | 2/29 (6.9%) | 2 |
| CREATININE | 2/29 (6.9%) | 6 |
| GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA) | 3/29 (10.3%) | 6 |
| GLUCOSE, SERUM-LOW (HYPOGLYCEMIA) | 2/29 (6.9%) | 3 |
| MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA) | 1/29 (3.4%) | 1 |
| POTASSIUM, SERUM-HIGH (HYPERKALEMIA) | 1/29 (3.4%) | 1 |
| POTASSIUM, SERUM-LOW (HYPOKALEMIA) | 4/29 (13.8%) | 4 |
| SODIUM, SERUM-LOW (HYPONATREMIA) | 5/29 (17.2%) | 9 |
| Musculoskeletal and connective tissue disorders | ||
| ARTHRITIS (NON-SEPTIC) | 3/29 (10.3%) | 3 |
| FRACTURE | 2/29 (6.9%) | 3 |
| MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / WHOLE BODY/GENERALIZED | 4/29 (13.8%) | 6 |
| MUSCULOSKELETAL/SOFT TISSUE - OTHER | 1/29 (3.4%) | 3 |
| OSTEOPOROSIS | 1/29 (3.4%) | 1 |
| PAIN / BONE | 3/29 (10.3%) | 3 |
| PAIN / EXTREMITY-LIMB | 7/29 (24.1%) | 11 |
| PAIN / JOINT | 7/29 (24.1%) | 13 |
| Nervous system disorders | ||
| COGNITIVE DISTURBANCE | 1/29 (3.4%) | 1 |
| CONFUSION | 1/29 (3.4%) | 1 |
| DIZZINESS | 6/29 (20.7%) | 8 |
| NEUROLOGY - OTHER | 1/29 (3.4%) | 1 |
| NEUROPATHY: MOTOR | 2/29 (6.9%) | 2 |
| NEUROPATHY: SENSORY | 17/29 (58.6%) | 17 |
| Psychiatric disorders | ||
| MOOD ALTERATION / ANXIETY | 10/29 (34.5%) | 10 |
| MOOD ALTERATION / DEPRESSION | 8/29 (27.6%) | 8 |
| Renal and urinary disorders | ||
| CYSTITIS | 1/29 (3.4%) | 1 |
| RENAL/GENITOURINARY - OTHER | 2/29 (6.9%) | 2 |
| Reproductive system and breast disorders | ||
| PAIN / BREAST | 1/29 (3.4%) | 1 |
| VAGINAL DRYNESS | 1/29 (3.4%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| COUGH | 11/29 (37.9%) | 11 |
| DYSPNEA (SHORTNESS OF BREATH) | 14/29 (48.3%) | 16 |
| OBSTRUCTION/STENOSIS OF AIRWAY / BRONCHUS | 1/29 (3.4%) | 1 |
| PAIN / CHEST WALL | 1/29 (3.4%) | 1 |
| PAIN / CHEST/THORAX NOS | 5/29 (17.2%) | 5 |
| PAIN / THROAT/PHARYNX/LARYNX | 1/29 (3.4%) | 1 |
| PLEURAL EFFUSION (NON-MALIGNANT) | 1/29 (3.4%) | 1 |
| PULMONARY FIBROSIS (RADIOGRAPHIC CHANGES) | 1/29 (3.4%) | 1 |
| PULMONARY/UPPER RESPIRATORY - OTHER | 3/29 (10.3%) | 3 |
| VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS) | 2/29 (6.9%) | 2 |
| Skin and subcutaneous tissue disorders | ||
| CHELITIS | 1/29 (3.4%) | 1 |
| DERMATOLOGY/SKIN - OTHER | 2/29 (6.9%) | 2 |
| FLUSHING | 3/29 (10.3%) | 3 |
| HAIR LOSS/ALOPECIA (SCALP OR BODY) | 6/29 (20.7%) | 6 |
| HYPERPIGMENTATION | 2/29 (6.9%) | 2 |
| NAIL CHANGES | 2/29 (6.9%) | 2 |
| PRURITUS/ITCHING | 7/29 (24.1%) | 7 |
| RASH/DESQUAMATION | 3/29 (10.3%) | 3 |
| RASH: ACNE/ACNEIFORM | 3/29 (10.3%) | 3 |
| RASH: HAND-FOOT SKIN REACTION | 1/29 (3.4%) | 1 |
| Vascular disorders | ||
| PORTAL VEIN FLOW | 1/29 (3.4%) | 1 |
| THROMBOSIS/THROMBUS/EMBOLISM | 1/29 (3.4%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT 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 | Principal Investigator |
|---|---|
| Organization | Hoosier Cancer Research Network, Inc. |
| Phone | 317-921-2050 |
| jsmith@hoosiercancer.org |
- HOG BRE07-126