## Protocol Section
### Identification Module
**NCT ID:** NCT02342379

**Brief Title:** TH-302 in Combination With Bevacizumab for Glioblastoma

**Official Title:** A Phase 2, Investigator Initiated Study to Determine the Safety and Efficacy of TH-302 in Combination With Bevacizumab for Glioblastoma Following Bevacizumab Failure

#### Organization Study ID Info
**ID:** CTRC 12-0105
#### Organization
**Class:** OTHER
**Full Name:** The University of Texas Health Science Center at San Antonio
#### Secondary ID Infos
**Domain:** UT Health Science Center Institutional Review Board
**ID:** HSC20130212H
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2019-12-04

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-04-10

**Type:** ACTUAL

**Last Update Submit Date:** 2020-04-09

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-01-04

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2020-04-10

**Type:** ACTUAL

**Results First Submit Date:** 2020-02-07

**Results First Submit QC Date:** 2020-04-09

#### Start Date
**Date:** 2015-05

**Status Verified Date:** 2020-04

#### Study First Post Date
**Date:** 2015-01-19
**Type:** ESTIMATED
**Study First Submit Date:** 2015-01-14
**Study First Submit QC Date:** 2015-01-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** The University of Texas Health Science Center at San Antonio

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Dual center, single arm, two-stage, non-blinded, prospective study of combination therapy bevacizumab at 10mg/kg and TH-302 at 670mg/m2 every 2 weeks (6 week cycle) until disease progression.

### Conditions Module

**Conditions:**

- Glioblastoma

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 35

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients will be treated with combination of bevacizumab and TH-302.

**Intervention Names:**

- Drug: Bevacizumab

- Drug: TH-302

**Label:** Bevacizumab and TH-302

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Bevacizumab and TH-302

**Description:** 10mg/kg

**Name:** Bevacizumab

**Other Names:**

- Avastin

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Bevacizumab and TH-302

**Description:** 670mg/m2

**Name:** TH-302

**Other Names:**

- MSC2491899A

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Safety lab tests and adverse event assessment

**Measure:** Number of Patients With Adverse Events

**Time Frame:** 4 months

#### Secondary Outcomes

**Description:** Progression of disease by RANO criteria:

The RANO criteria divides response into four types of response based on imaging and clinical features

1. complete response
2. partial response
3. stable disease
4. progression

**Measure:** Progression Free Survival

**Time Frame:** 4 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* At least 18 years of age
* Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee
* Histologically confirmed glioblastoma
* Progression following both standard combined modality treatment with radiation and temozolomide chemotherapy, as well as bevacizumab
* Recovered from toxicities of prior therapy to grade 0 or 1
* ECOG performance status ≤ 2
* Life expectancy of at least 3 months
* Acceptable liver function:

  1. Bilirubin ≤ 1.5 times upper limit of normal
  2. AST (SGOT) and ALT (SGPT) ≤ 3.0 times upper limit of normal (ULN);
* Acceptable renal function:

  a. Serum creatinine ≤ULN
* Acceptable hematologic status (without hematologic support):

  1. ANC ≥1500 cells/uL
  2. Platelet count ≥100,000/uL
  3. Hemoglobin ≥9.0 g/dL
* All women of childbearing potential must have a negative serum pregnancy test and male and female subjects must agree to use effective means of contraception (surgical sterilization or the use or barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose

Exclusion Criteria:

* The subject is receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin (LMWH) before the first dose of study drug.
* The subject has evidence of acute intracranial or intratumoral hemorrhage either by MRI or computerized tomography (CT) scan. Subjects with resolving hemorrhage, punctate hemorrhage, or hemosiderin are eligible.
* The subject is unable to undergo MRI scan (eg, has pacemaker).
* The subject has received enzyme-inducing anti-epileptic agents within 14 days of study drug (eg, carbamazepine, phenytoin, phenobarbital, primidone).
* The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade ≤ 1 from AEs (except alopecia, anemia and lymphopenia) due to surgery, antineoplastic agents, investigational drugs, or other medications that were administered prior to study drug.
* The subject has evidence of wound dehiscence
* Severe chronic obstructive or other pulmonary disease with hypoxemia (requires supplementary oxygen, symptoms due to hypoxemia or oxygen saturation \<90% by pulse oximetry after a 2 minute walk) or in the opinion of the investigator any physiological state likely to cause normal tissue hypoxia
* The subject is pregnant or breast-feeding.
* The subject has serious intercurrent illness, such as:

  1. hypertension (two or more blood pressure \[BP\] readings performed at screening of \> 150 mmHg systolic or \> 100 mmHg diastolic) despite optimal treatment
  2. non-healing wound, ulcer, or bone fracture
  3. significant cardiac arrhythmias
  4. untreated hypothyroidism
  5. uncontrolled active infection
  6. symptomatic congestive heart failure or unstable angina pectoris within 3 months prior study drug
  7. myocardial infarction, stroke, transient ischemic attack within 6 months
  8. gastrointestinal perforation, abdominal fistula, intra- abdominal abscess within 1 year
  9. history or clinical evidence of pancreatitis within 2 years
* The subject has inherited bleeding diathesis or coagulopathy with the risk of bleeding.
* The subject has received any of the following prior anticancer therapy:

  1. Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy, or intra-operative radiotherapy (IORT). Note: stereotactic radiosurgery (SRS) is allowed
  2. Non-bevacizumab systemic therapy (including investigational agents and small-molecule kinase inhibitors) or non-cytotoxic hormonal therapy (eg, tamoxifen) within 7 days or 5 half-lives, whichever is shorter, prior first dose of study drug
  3. Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to first dose of study drug
  4. Nitrosoureas or mitomycin C within 42 days, or metronomic/protracted low-dose chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days, prior to first dose of study drug
  5. Prior treatment with carmustine wafers
  6. Prior treatment with TH-302

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Boston

**Country:** United States

**Facility:** Dana-Farber Cancer Institute

**State:** Massachusetts

**Zip:** 02215

**Location 2:**

**City:** San Antonio

**Country:** United States

**Facility:** University of Texas Health Science Center San Antonio at the Cancer Therapy and Research Center

**State:** Texas

**Zip:** 78229

#### Overall Officials

**Official 1:**

**Affiliation:** University of Texas Health Science Center San Antonio at the Cancer Therapy and Research Center

**Name:** Andrew Brenner, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Document Section

### Large Document Module

#### Large Docs

- Date: 2017-04-04

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 1992823

- Type Abbrev: Prot_SAP

- Upload Date: 2020-01-10T16:14

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001254

- Term: Astrocytoma

- ID: D000005910

- Term: Glioma

- ID: D000018302

- Term: Neoplasms, Neuroepithelial

- ID: D000017599

- Term: Neuroectodermal Tumors

- ID: D000009373

- Term: Neoplasms, Germ Cell and Embryonal

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009380

- Term: Neoplasms, Nerve Tissue

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M9019

- Name: Glioblastoma

- Relevance: HIGH

- As Found: Glioblastoma

- ID: M4561

- Name: Astrocytoma

- Relevance: LOW

- As Found: Unknown

- ID: M9020

- Name: Glioma

- Relevance: LOW

- As Found: Unknown

- ID: M20446

- Name: Neoplasms, Neuroepithelial

- Relevance: LOW

- As Found: Unknown

- ID: M19845

- Name: Neuroectodermal Tumors

- Relevance: LOW

- As Found: Unknown

- ID: M20388

- Name: Neuroectodermal Tumors, Primitive

- Relevance: LOW

- As Found: Unknown

- ID: M12318

- Name: Neoplasms, Germ Cell and Embryonal

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12325

- Name: Neoplasms, Nerve Tissue

- Relevance: LOW

- As Found: Unknown

- ID: T2518

- Name: Glioblastoma

- Relevance: HIGH

- As Found: Glioblastoma

- ID: T2519

- Name: Glioma

- Relevance: LOW

- As Found: Unknown

- ID: T4092

- Name: Neuroepithelioma

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005909

- Term: Glioblastoma

### Intervention Browse Module - Ancestors

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000020533

- Term: Angiogenesis Inhibitors

- ID: D000043924

- Term: Angiogenesis Modulating Agents

- ID: D000006133

- Term: Growth Substances

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000006131

- Term: Growth Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M246

- Name: Bevacizumab

- Relevance: HIGH

- As Found: Non-

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

- ID: M22318

- Name: Angiogenesis Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M9231

- Name: Growth Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000068258

- Term: Bevacizumab

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Bevacizumab and TH-302

**Deaths Num At Risk:** 35

**Description:** Patients will be treated with combination of bevacizumab and TH-302.

Bevacizumab: 10mg/kg

TH-302: 670mg/m2

**ID:** EG000

**Other Num Affected:** 35

**Other Num at Risk:** 35

**Serious Number At Risk:** 35

**Title:** Bevacizumab and TH-302

**Frequency Threshold:** 0

#### Other Events

**Term:** Abscess (left axillary abscess)

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Anemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** 

**Term:** Anorexia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Cognitive Disturbance

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** confusion

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Nasal congestion

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Constipation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Decreased Appetite

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Decreased Platelets

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** 

**Term:** Dermatitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Diarrhea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Dry Skin

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Edema (pedal)

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** 

**Term:** Epistaxis (intermittent)

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** Bleeding of the nose

**Organ System:** Vascular disorders

**Source Vocabulary:** 

**Term:** Facial Erythema

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Blurred vision/diplopia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** 

**Term:** Fatigue

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Fever

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Flu

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** Upper respiratory tract infection

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Headache

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Heartburn

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Hemorrhoid

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Herpes Simplex Virus

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Hoarsness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Hyperglycemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** 

**Term:** Hyperkeratosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** palmar plantar erythrodysethesia syndrome

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Hyperpigmentation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Hypertension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** High blood pressure

**Organ System:** Cardiac disorders

**Source Vocabulary:** 

**Term:** Kratoderma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Leukopenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** Decreased white blood cell count

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** 

**Term:** Lung Infection (PNA)

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Mouth Sores

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Anal Mucositis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Oral Mucositis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Perianal Mucositis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Rectal Mucositis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Vaginal Mucositis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** 

**Term:** Nausea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Neutropenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** 

**Term:** Pain, abdominal

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Pain, rectal

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Phlebitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** Left anticubital fossa

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** 

**Term:** Photosensitivity Reaction

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Proteinuria

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** 

**Term:** Pruritis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Rash

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Scar

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Skin Abrasion

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Skin Atrophy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** Peeling

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Skin Irritation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** Groin

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Skin excoriation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** Right armpit

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Other skin excoriation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** Labial/vaginal/rectal

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Skin Ulceration

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Small intestine perforation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Thrombocytopenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** 

**Term:** Dysuria

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** 

**Term:** Urinary Tract Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** 

**Term:** Vaginal Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** 

**Term:** Vomiting

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Weakness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** Left sided weakness

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Wound complication

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** Delayed healing of right chest wall

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Time Frame:** Adverse events are collected from start of drug administration until 30 days after study drug is discontinued, giving a total of 5 months potential evaluation period.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 35

**Units:** Participants

### Group

**ID:** BG000

**Title:** Bevacizumab and TH-302

**Description:** Patients will be treated with combination of bevacizumab and TH-302.

Bevacizumab: 10mg/kg

TH-302: 670mg/m2

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

**Class Title:** 18-21 years

#### Measurement

**Group ID:** BG000

**Value:** 4

**Class Title:** 22-29 years

#### Measurement

**Group ID:** BG000

**Value:** 7

**Class Title:** 30-39 years

#### Measurement

**Group ID:** BG000

**Value:** 4

**Class Title:** 40-49 years

#### Measurement

**Group ID:** BG000

**Value:** 11

**Class Title:** 50-59 years

#### Measurement

**Group ID:** BG000

**Value:** 6

**Class Title:** 60-69 years

#### Measurement

**Group ID:** BG000

**Value:** 2

**Class Title:** 70-79 years

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 11

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 24

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 10

**Class Title:** White : Female

#### Measurement

**Group ID:** BG000

**Value:** 15

**Class Title:** White : Male

#### Measurement

**Group ID:** BG000

**Value:** 0

**Class Title:** Black or African American : Female

#### Measurement

**Group ID:** BG000

**Value:** 1

**Class Title:** Black or African American : Male

#### Measurement

**Group ID:** BG000

**Value:** 1

**Class Title:** White/Hispanic or Latino : Female

#### Measurement

**Group ID:** BG000

**Value:** 6

**Class Title:** White/Hispanic or Latino : Male

#### Measurement

**Group ID:** BG000

**Value:** 0

**Class Title:** Asian : Female

#### Measurement

**Group ID:** BG000

**Value:** 2

**Class Title:** Asian : Male

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 35

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Customized
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** brennera@uthscsa.edu
**Organization:** University of Texas Health San Antonio
**Phone:** 210-450-5936
**Title:** Andrew Brenner, MD, PhD
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 35
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 32
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Safety lab tests and adverse event assessment
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** 4 months
**Title:** Number of Patients With Adverse Events
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Patients will be treated with combination of bevacizumab and TH-302.

Bevacizumab: 10mg/kg

TH-302: 670mg/m2
**ID:** OG000
**Title:** Bevacizumab and TH-302
#### Outcome Measure 2
**Description:** Progression of disease by RANO criteria:

The RANO criteria divides response into four types of response based on imaging and clinical features

1. complete response
2. partial response
3. stable disease
4. progression
**Parameter Type:** NUMBER
**Population Description:** 3 of the enrolled participants were not evaluable
**Reporting Status:** POSTED
**Time Frame:** 4 months
**Title:** Progression Free Survival
**Type:** SECONDARY
**Unit of Measure:** Number of participants
##### Group
**Description:** Patients will be treated with combination of bevacizumab and TH-302.

Bevacizumab: 10mg/kg

TH-302: 670mg/m2
**ID:** OG000
**Title:** Bevacizumab and TH-302
### Participant Flow Module
#### Group
**Description:** Patients will be treated with combination of bevacizumab and TH-302.

Bevacizumab: 10mg/kg

TH-302: 670mg/m2
**ID:** FG000
**Title:** Bevacizumab and TH-302
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 35
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 35
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
**Has Results:** True