## Protocol Section
### Identification Module
**NCT ID:** NCT01609179

**Brief Title:** IPI-926 Extension Protocol for Continuation of Treatment With IPI-926

**Official Title:** IPI-926 Extension Protocol for Continuation of IPI-926 Treatment in Patients Experiencing Clinical Benefit While Enrolled in an IPI-926 Protocol

#### Organization Study ID Info
**ID:** IPI-926-09
#### Organization
**Class:** INDUSTRY
**Full Name:** Infinity Pharmaceuticals, Inc.
### Status Module
#### Completion Date
**Date:** 2012-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-11-14

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-11-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2012-10

**Type:** ACTUAL

#### Start Date
**Date:** 2012-03

**Status Verified Date:** 2012-11

#### Study First Post Date
**Date:** 2012-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2012-05-29
**Study First Submit QC Date:** 2012-05-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Infinity Pharmaceuticals, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** A treatment protocol that enables patients to have continued access to IPI-926.

**Detailed Description:** The extension protocol is a continuation of treatment with IPI-926, as administered to each individual patient during participation in their original IPI-926 protocol.

Patients who are completing their participation in the original IPI-926 protocol in which they enrolled, as defined in the original protocol, and, have stable disease or confirmed complete or partial response as defined by the original protocol may continue to receive treatment with IPI-926 in the extension protocol.

### Conditions Module

**Conditions:**

- Basal Cell Carcinoma

- Chondrosarcoma

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 9

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: IPI-926

**Label:** IPI-926

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- IPI-926

**Description:** IPI-926 is administered orally as a capsule formulation, as a fixed dose in mg/day. Patients will be administered the same dose with same cycle length of IPI-926 and combination therapy that they were receiving in the original protocol at the time of transition into the extension study. The following are potential once-daily doses that patients are receiving in original protocols: 60 mg, 90 mg, 100 mg, 110 mg, 130 mg, or 160 mg.

**Name:** IPI-926

**Other Names:**

- saridegib

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Monitoring of AEs, including SAEs as well as review of laboratory sample test data to assess safety and tolerability of IPI-926

**Measure:** Incidence of adverse events (AEs) and serious adverse events (SAEs), and laboratory test results

**Time Frame:** Up to 30 days after the last patient study visit

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Voluntarily sign the informed consent form
2. Currently receiving IPI-926 while participating in an Infinity-sponsored IPI-926 study. Note: For blinded studies, patient's treatment assignment must be unblinded according to the instructions in the original protocol to confirm they are receiving IPI-926.
3. Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1.
4. Documented response or stable disease, as defined in the original protocol, at the time of entry to the extension study.
5. Willingness and ability to continue IPI-926 dispensation and follow-up procedures at the current investigational site.
6. Willingness and ability to comply with scheduled visits, treatment plans, and laboratory tests and other study procedures.
7. Women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months, must have a negative serum or urine pregnancy test prior to treatment. All WCBP, all sexually active male patients, and all partners of patients must agree to use adequate methods of birth control throughout the study.

Exclusion Criteria:

1. Discontinued IPI-926 or withdrew informed consent to participate in original Infinity-sponsored IPI-926 study.
2. Require addition of or change to a new concomitant therapy to adequately treat the malignancy under study.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Aurora

**Country:** United States

**Facility:** University of Colorado Denver

**State:** Colorado

**Zip:** 80045

**Location 2:**

**City:** Baltimore

**Country:** United States

**Facility:** Johns Hopkins

**State:** Maryland

**Zip:** 21205

#### Overall Officials

**Official 1:**

**Affiliation:** Infinity Pharmaceuticals, Inc.

**Name:** Tess Schmalbach, MD

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000018295

- Term: Neoplasms, Basal Cell

- ID: D000009372

- Term: Neoplasms, Connective Tissue

- ID: D000018204

- Term: Neoplasms, Connective and Soft Tissue

- ID: D000012509

- Term: Sarcoma

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M5537

- Name: Carcinoma, Basal Cell

- Relevance: HIGH

- As Found: Basal Cell Carcinoma

- ID: M6053

- Name: Chondrosarcoma

- Relevance: HIGH

- As Found: Chondrosarcoma

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M20439

- Name: Neoplasms, Basal Cell

- Relevance: LOW

- As Found: Unknown

- ID: M12317

- Name: Neoplasms, Connective Tissue

- Relevance: LOW

- As Found: Unknown

- ID: M20350

- Name: Neoplasms, Connective and Soft Tissue

- Relevance: LOW

- As Found: Unknown

- ID: M15327

- Name: Sarcoma

- Relevance: LOW

- As Found: Unknown

- ID: T1172

- Name: Chondrosarcoma

- Relevance: HIGH

- As Found: Chondrosarcoma

- ID: T5284

- Name: Soft Tissue Sarcoma

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002280

- Term: Carcinoma, Basal Cell

- ID: D000002813

- Term: Chondrosarcoma

### Misc Info Module

- Version Holder: 2024-05-24
