Trial · NCT01296555

A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Participants With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma (NHL) and in Combination With Endocrine Therapy in Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer

NCT01296555, Phase 1, Terminated, Genentech, Inc.; results first posted 2024-07-31

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Participants With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma (NHL) and in Combination With Endocrine Therapy in Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer. Trials, record NCT01296555. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01296555

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Participants With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma (NHL) and in Combination With Endocrine Therapy in Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer
NCT number: NCT01296555
Status: Terminated
Phases: Phase 1
Enrollment: 674 participants, actual
Lead sponsor: Genentech, Inc.
Conditions: Solid Cancers, Non-Hodgkin's Lymphoma
Interventions: Fulvestrant, GDC-0032, Letrozole, Midazolam
First posted: 2011-02-15
Last updated: 2024-07-31
Other registries' IDs: eudract:2012-002042-21
Results first posted: 2024-07-31

Source ClinicalTrials.gov

Registered outcomes22

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Phase I Stage 1: Percentage of Participants With Dose-Limiting Toxicities (DLTs) as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0)	Baseline up to 35 days of Cycle 1	A DLT is defined as any one of the following toxicities occurring within the DLT Assessment Window (Days 1-35 of Cycle 1 in Stage 1) assessed by the investigator: Grade ≥ 3 non-hematologic, non-hepatic organ system, non-metabolic (hyperglycemia and hyperlipidemia) toxicity, excluding alopecia of any grade, Grade 3 diarrhea, Grade 3 nausea or vomiting; Grade ≥ 4 thrombocytopenia; Grade ≥ 4 neutropenia lasting \> 5 days or accompanied by fever; Fasting Grade ≥ 4 hyperglycemia or ≥ 3 hyperglycemia for ≥ 1 week; Grade ≥ 4 fasting hypercholesterolemia or triglyceridemia for ≥ 2 weeks; Grade ≥ 3 serum bilirubin or hepatic transaminase (ALT or AST); For participants abnormal at baseline: hepatic transaminase ≥ 7.5 × the upper limit of normal (ULN) or total bilirubin ≥ 5 × the ULN or 10 × the ULN or alkaline phosphatase ≥ 10 times the ULN.
Primary	Phase I Stage 2 Cohorts E and F: Percentage of Participants With DLTs as Assessed by NCI CTCAE v4.0	Baseline up to 28 days of Cycle 1	A DLT is defined as any one of the following toxicities occurring within the DLT Assessment Window (Days 1-28 of Cycle 1 in Stage 1) assessed by the investigator: Grade ≥ 3 non-hematologic, non-hepatic organ system, non-metabolic (hyperglycemia and hyperlipidemia) toxicity, excluding alopecia of any grade, Grade 3 diarrhea, Grade 3 nausea or vomiting; Grade ≥ 4 thrombocytopenia; Grade ≥ 4 neutropenia lasting \> 5 days or accompanied by fever; Fasting Grade ≥ 4 hyperglycemia or ≥ 3 hyperglycemia for ≥ 1 week; Grade ≥ 4 fasting hypercholesterolemia or triglyceridemia for ≥ 2 weeks; Grade ≥ 3 serum bilirubin or hepatic transaminase (ALT or AST); For participants abnormal at baseline: hepatic transaminase ≥ 7.5 × ULN or total bilirubin ≥ 5 × the ULN or 10 × the ULN or alkaline phosphatase ≥ 10 times the ULN.
Primary	Phase I: AUC From Zero to Tau (AUCtau) of GDC-0032	Cycle 1, Day 1: Pre-dose (0-2 hours [hr]), 0.5, 1, 2, 3, 4, 8, 24, 48 and 72 hr; Day 15: Pre-dose (0-2 hr), 0.5, 1, 2, 3, 4, 8 and 24 hr	The concentrations are in micromole (µM), and the molecular weight of GDC-0032 is 460.53 g/mol.
Primary	Phase I: Maximum Observed Plasma Concentration (Cmax) of GDC-0032	Cycle 1, Day 1: Pre-dose (0-2 hours [hr]), 0.5, 1, 2, 3, 4, 8, 24, 48 and 72 hr; Day 15: Pre-dose (0-2 hr), 0.5, 1, 2, 3, 4, 8 and 24 hr	The concentrations are in micromole (µM), and the molecular weight of GDC-0032 is 460.53 g/mol.
Primary	Phase I: Time to Reach Cmax (Tmax) of GDC-0032	Cycle 1, Day 1: Pre-dose (0-2 hours [hr]), 0.5, 1, 2, 3, 4, 8, 24, 48 and 72 hr
Primary	Phase I: Terminal Half-life (t1/2) of GDC-0032	Cycle 1, Day 1: Pre-dose (0-2 hours [hr]), 0.5, 1, 2, 3, 4, 8, 24, 48 and 72 hr
Primary	Across All Cohorts (Except Cohorts T and T2): Percentage of Participants With Best Overall Response (BOR) as Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)	Baseline up to disease progression or death, whichever occurred first (up to a maximum of 67 months)	BOR was defined as having best objective response as complete response (CR) or partial response (PR), as assessed by RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
Primary	Across All Cohorts (Except Cohorts T and T2): Duration of Objective Response (DOR) as Assessed Using RECIST v1.1	Baseline up to disease progression or death, whichever occurred first (up to a maximum of 67 months)	DOR was defined as the time from the first occurrence of a documented objective response (OR) to progressive disease (PD) or death from any cause (whichever occurred first) as determined by the investigator according to RECIST v1.1. OR=CR+PR. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm. Number of participants analyzed signifies the number of responders.
Primary	Across All Cohorts (Except Cohorts T and T2): Progression-Free Survival (PFS) as Assessed Using RECIST v1.1	Baseline up to disease progression or death, whichever occurred first (up to a maximum of 67 months)	PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause (whichever occurred first), as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Primary	Percentage of Participants With BOR in Cohort T and T2	Baseline up to disease progression or death, whichever occurs first (up to a maximum of 46 months)	BOR in Cohort T was assessed using the 2007 Revised International Working Group (IWG) Response Criteria in Malignant Lymphoma while in Cohort T2, BOR was assessed using the Modified Version of 2014 Lugano Response Criteria in Malignant Lymphoma.

1 to 10 of 22Source ClinicalTrials.gov

See all 22 registered outcomes

Outcomes22

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Phase I Stage 1: Percentage of Participants With Dose-Limiting Toxicities (DLTs) as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0)	Baseline up to 35 days of Cycle 1	The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.	percentage of participants	NUMBER
PRIMARY	Phase I Stage 2 Cohorts E and F: Percentage of Participants With DLTs as Assessed by NCI CTCAE v4.0	Baseline up to 28 days of Cycle 1	The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.	percentage of participants	NUMBER
PRIMARY	Phase I: AUC From Zero to Tau (AUCtau) of GDC-0032	Cycle 1, Day 1: Pre-dose (0-2 hours [hr]), 0.5, 1, 2, 3, 4, 8, 24, 48 and 72 hr; Day 15: Pre-dose (0-2 hr), 0.5, 1, 2, 3, 4, 8 and 24 hr	The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant. 'Number Analyzed' signifies number of participants analyzed for this outcome measure at the specified timepoint.	micromolar per hour (µM*h)	MEAN
PRIMARY	Phase I: Maximum Observed Plasma Concentration (Cmax) of GDC-0032	Cycle 1, Day 1: Pre-dose (0-2 hours [hr]), 0.5, 1, 2, 3, 4, 8, 24, 48 and 72 hr; Day 15: Pre-dose (0-2 hr), 0.5, 1, 2, 3, 4, 8 and 24 hr	The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant. 'Number Analyzed' signifies number of participants analyzed for this outcome measure at the specified timepoint.	micromolar (µM)	MEAN
PRIMARY	Phase I: Time to Reach Cmax (Tmax) of GDC-0032	Cycle 1, Day 1: Pre-dose (0-2 hours [hr]), 0.5, 1, 2, 3, 4, 8, 24, 48 and 72 hr	The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.	hours (hr)	MEDIAN
PRIMARY	Phase I: Terminal Half-life (t1/2) of GDC-0032	Cycle 1, Day 1: Pre-dose (0-2 hours [hr]), 0.5, 1, 2, 3, 4, 8, 24, 48 and 72 hr	The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.	hr	MEAN
PRIMARY	Across All Cohorts (Except Cohorts T and T2): Percentage of Participants With Best Overall Response (BOR) as Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)	Baseline up to disease progression or death, whichever occurred first (up to a maximum of 67 months)	The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.	percentage of participants	NUMBER
PRIMARY	Across All Cohorts (Except Cohorts T and T2): Duration of Objective Response (DOR) as Assessed Using RECIST v1.1	Baseline up to disease progression or death, whichever occurred first (up to a maximum of 67 months)	The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.	months	MEDIAN
PRIMARY	Across All Cohorts (Except Cohorts T and T2): Progression-Free Survival (PFS) as Assessed Using RECIST v1.1	Baseline up to disease progression or death, whichever occurred first (up to a maximum of 67 months)	The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.	months	MEDIAN
PRIMARY	Percentage of Participants With BOR in Cohort T and T2	Baseline up to disease progression or death, whichever occurs first (up to a maximum of 46 months)	The safety-evaluable population was defined as all participants who received at least one dose of GDC-0032, letrozole, or fulvestrant.	percentage of participants	NUMBER

1 to 10 of 22Source ClinicalTrials.gov

See all 22 outcomes

Results by group154

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Phase I Stage 1: Percentage of Participants With Dose-Limiting Toxicities (DLTs) as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0)	Phase I, Stage 1: GDC-0032 3 mg QD		0.0		percentage of participants
Phase I Stage 1: Percentage of Participants With Dose-Limiting Toxicities (DLTs) as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0)	Phase I, Stage 1: GDC-0032 5 mg QD		0.0		percentage of participants
Phase I Stage 1: Percentage of Participants With Dose-Limiting Toxicities (DLTs) as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0)	Phase I, Stage 1: GDC-0032 8 mg QD		0.0		percentage of participants
Phase I Stage 1: Percentage of Participants With Dose-Limiting Toxicities (DLTs) as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0)	Phase I, Stage 1: GDC-0032 12 mg QD		10.0		percentage of participants
Phase I Stage 1: Percentage of Participants With Dose-Limiting Toxicities (DLTs) as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0)	Phase I, Stage 1: GDC-0032 16 mg QD		18.1		percentage of participants
Phase I Stage 2 Cohorts E and F: Percentage of Participants With DLTs as Assessed by NCI CTCAE v4.0	Phase I, Stage 2: Cohort E - GDC-0032 6 mg QD + Letrozole 2.5 mg QD		0.0		percentage of participants
Phase I Stage 2 Cohorts E and F: Percentage of Participants With DLTs as Assessed by NCI CTCAE v4.0	Phase I, Stage 2: Cohort E - GDC-0032 9 mg QD + Letrozole 2.5 mg QD		0.0		percentage of participants
Phase I Stage 2 Cohorts E and F: Percentage of Participants With DLTs as Assessed by NCI CTCAE v4.0	Phase I, Stage 2: Cohort F - GDC-0032 6 mg QD + Fulvestrant 500 mg		0.0		percentage of participants
Phase I Stage 2 Cohorts E and F: Percentage of Participants With DLTs as Assessed by NCI CTCAE v4.0	Phase I, Stage 2: Cohort F - GDC-0032 9 mg QD + Fulvestrant 500 mg		0.0		percentage of participants
Phase I: AUC From Zero to Tau (AUCtau) of GDC-0032	Phase I, Stage 1: GDC-0032 3 Milligrams (mg) Once Daily (QD)	Day 1	0.441	Standard Deviation 0.142	micromolar per hour (µM*h)

1 to 10 of 154Source ClinicalTrials.gov

See all 154 results by group

Participant flow87

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Phase I, Stage 1: GDC-0032 3 Milligrams (mg) Once	6
Overall Study	STARTED	Phase I, Stage 1: GDC-0032 5 mg QD	3
Overall Study	STARTED	Phase I, Stage 1: GDC-0032 8 mg QD	4
Overall Study	STARTED	Phase I, Stage 1: GDC-0032 12 mg QD	10
Overall Study	STARTED	Phase I, Stage 1: GDC-0032 16 mg QD	11
Overall Study	STARTED	Phase I, Stage 2: Cohort A - GDC-0032 9 mg QD	20
Overall Study	STARTED	Phase I, Stage 2: Cohort B - GDC-0032 9 mg QD	20
Overall Study	STARTED	Phase I, Stage 2: Cohort C - GDC-0032 9 mg QD + Midazolam 5 mg	13
Overall Study	STARTED	Phase I, Stage 2: Cohort D - GDC-0032 9 mg QD	10
Overall Study	STARTED	Phase I, Stage 2: Cohort E - GDC-0032 6 mg QD + Letrozole 2.5 mg QD	20

1 to 10 of 87Source ClinicalTrials.gov

See all 87 participant flow

Adverse events18,473

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	DIARRHOEA	Gastrointestinal disorders	Phase I, Stage 1: GDC-0032 3 Milligrams (mg) Once	1	6	2
other	DIARRHOEA	Gastrointestinal disorders	Phase I, Stage 1: GDC-0032 5 mg QD	2	3	2
other	DIARRHOEA	Gastrointestinal disorders	Phase I, Stage 1: GDC-0032 8 mg QD	1	4	1
other	DIARRHOEA	Gastrointestinal disorders	Phase I, Stage 1: GDC-0032 12 mg QD	7	10	14
other	DIARRHOEA	Gastrointestinal disorders	Phase I, Stage 1: GDC-0032 16 mg QD	9	11	20
other	DIARRHOEA	Gastrointestinal disorders	Phase I, Stage 2: Cohort A - GDC-0032 9 mg QD	10	20	52
other	DIARRHOEA	Gastrointestinal disorders	Phase I, Stage 2: Cohort B - GDC-0032 9 mg QD	16	20	31
other	DIARRHOEA	Gastrointestinal disorders	Phase I, Stage 2: Cohort C - GDC-0032 9 mg QD + Midazolam 5 mg	9	13	13
other	DIARRHOEA	Gastrointestinal disorders	Phase I, Stage 2: Cohort D - GDC-0032 9 mg QD	5	10	10
other	DIARRHOEA	Gastrointestinal disorders	Phase I, Stage 2: Cohort E - GDC-0032 6 mg QD + Letrozole 2.5 mg QD	15	20	38

1 to 10 of 18,473Source ClinicalTrials.gov

See all 18,473 adverse events

Adverse event totals87

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phase I, Stage 1: GDC-0032 3 Milligrams (mg) Once	0	6
Total, all-cause mortality	Phase I, Stage 1: GDC-0032 5 mg QD	0	3
Total, all-cause mortality	Phase I, Stage 1: GDC-0032 8 mg QD	0	4
Total, all-cause mortality	Phase I, Stage 1: GDC-0032 12 mg QD	2	10
Total, all-cause mortality	Phase I, Stage 1: GDC-0032 16 mg QD	1	11
Total, all-cause mortality	Phase I, Stage 2: Cohort A - GDC-0032 9 mg QD	0	20
Total, all-cause mortality	Phase I, Stage 2: Cohort B - GDC-0032 9 mg QD	2	20
Total, all-cause mortality	Phase I, Stage 2: Cohort C - GDC-0032 9 mg QD + Midazolam 5 mg	0	13
Total, all-cause mortality	Phase I, Stage 2: Cohort D - GDC-0032 9 mg QD	0	10
Total, all-cause mortality	Phase I, Stage 2: Cohort E - GDC-0032 6 mg QD + Letrozole 2.5 mg QD	1	20

1 to 10 of 87Source ClinicalTrials.gov

See all 87 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38937298	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01296555

GET https://conductscience.org/api/trials/v1/NCT01296555/registered?page=2

API reference For AI assistants